Trial Outcomes & Findings for Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis (NCT NCT00838565)

Last Updated: 2018-11-02

Results Overview

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)

Results posted on

2018-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Overall Study STARTED	9	7	6	6	6	7
Overall Study Treated	9	6	6	6	6	7
Overall Study COMPLETED	9	4	5	6	6	5
Overall Study NOT COMPLETED	0	3	1	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-04236921 1 mg PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Overall Study Withdrawal by Subject	0	1	2
Overall Study Other	2	0	0
Overall Study Randomized but not Treated	1	0	0

Baseline Characteristics

Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=9 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=6 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg n=7 Participants PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	Total n=40 Participants Total of all reporting groups
Age, Continuous	59.6 years STANDARD_DEVIATION 8.5 • n=5 Participants	61.7 years STANDARD_DEVIATION 7.9 • n=7 Participants	49.8 years STANDARD_DEVIATION 13.5 • n=5 Participants	46.0 years STANDARD_DEVIATION 4.1 • n=4 Participants	56.7 years STANDARD_DEVIATION 8.9 • n=21 Participants	55.4 years STANDARD_DEVIATION 9.8 • n=8 Participants	55.2 years STANDARD_DEVIATION 10.1 • n=8 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	34 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	6 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=6 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg n=7 Participants PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	9 participants	4 participants	4 participants	6 participants	6 participants	5 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 participants	0 participants	0 participants	2 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)

Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Number of Participants With Positive Anti-drug Antibodies Response Day 56	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With Positive Anti-drug Antibodies Response Day 84	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With Positive Anti-drug Antibodies Response Day 1	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With Positive Anti-drug Antibodies Response Day 28	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With Positive Anti-drug Antibodies Response Day 174	0 participants	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With Positive Anti-drug Antibodies Response Day 354	—	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With Positive Anti-drug Antibodies Response End of Study	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose

Population: Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Maximum Observed Serum Concentration (Cmax): Day 1	421.6 nanogram per milliliter (ng/mL) Standard Deviation 162.89	4631 nanogram per milliliter (ng/mL) Standard Deviation 1429.9	11320 nanogram per milliliter (ng/mL) Standard Deviation 2167.2	42290 nanogram per milliliter (ng/mL) Standard Deviation 7883.0	66280 nanogram per milliliter (ng/mL) Standard Deviation 59405	—

PRIMARY outcome

Timeframe: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose

Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1	0.0521 days Interval 0.0521 to 0.0528	0.0521 days Interval 0.0521 to 0.0521	0.0521 days Interval 0.0521 to 0.0521	0.0521 days Interval 0.0278 to 0.0521	0.0521 days Interval 0.0521 to 0.0528	—

PRIMARY outcome

Timeframe: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose

Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.

AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1	1899 ng*day/mL Standard Deviation 1090.1	19570 ng*day/mL Standard Deviation 5335.7	54140 ng*day/mL Standard Deviation 9345.0	206000 ng*day/mL Standard Deviation 40578	348500 ng*day/mL Standard Deviation 336540	—

PRIMARY outcome

Timeframe: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose

Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=5 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Maximum Observed Serum Concentration (Cmax): Day 28	617.6 ng/mL Standard Deviation 430.18	4719 ng/mL Standard Deviation 1807.2	13680 ng/mL Standard Deviation 3453.2	57280 ng/mL Standard Deviation 6396.4	158300 ng/mL Standard Deviation 50966	—

PRIMARY outcome

Timeframe: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=5 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28	0.0521 days Interval 0.0521 to 0.0528	0.0521 days Interval 0.0521 to 0.0521	0.0521 days Interval 0.0521 to 0.0521	0.0521 days Interval 0.0521 to 0.0528	0.0521 days Interval 0.0514 to 0.0521	—

PRIMARY outcome

Timeframe: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose

AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=5 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28	3104 ng*day/mL Standard Deviation 2369.7	21660 ng*day/mL Standard Deviation 7232.7	76510 ng*day/mL Standard Deviation 19496	316900 ng*day/mL Standard Deviation 45597	767900 ng*day/mL Standard Deviation 213320	—

PRIMARY outcome

Timeframe: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=5 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Maximum Observed Serum Concentration (Cmax): Day 56	741.0 ng/mL Standard Deviation 977.35	4424 ng/mL Standard Deviation 1384.8	19650 ng/mL Standard Deviation 1537.5	64850 ng/mL Standard Deviation 13289	164600 ng/mL Standard Deviation 35644	—

PRIMARY outcome

Timeframe: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=5 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56	0.0521 days Interval 0.0521 to 0.0542	0.0521 days Interval 0.0521 to 0.0521	0.0521 days Interval 0.0521 to 0.0521	0.0521 days Interval 0.0521 to 0.0521	0.0521 days Interval 0.0521 to 0.0528	—

PRIMARY outcome

Timeframe: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose

AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=5 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=7 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56	3730 ng*day/mL Standard Deviation 4479.8	23200 ng*day/mL Standard Deviation 7558.6	101100 ng*day/mL Standard Deviation 6438.2	389100 ng*day/mL Standard Deviation 71949	912200 ng*day/mL Standard Deviation 209610	—

PRIMARY outcome

Timeframe: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose

Serum decay half-life is the time measured for the serum concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=5 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=5 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=6 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Serum Decay Half-Life (t1/2): Day 56	45.50 days Full Range NA • Interval 45.0 to 46.0	36.90 days Full Range 11.010 • Interval 19.3 to 49.5	45.30 days Full Range 9.5166 • Interval 32.9 to 54.3	38.80 days Full Range 6.9500 • Interval 35.5 to 51.7	51.70 days Full Range 9.2230 • Interval 31.9 to 59.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation

Population: Pharmacodynamic analysis set included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Data collected at Early Discontinuation included those subjects who left the study early.'N' (number of participants analyzed) = participants who were evaluable for this measure.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra sensitive assay. A decrease in the level of CRP indicates reduction in inflammation.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=5 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=6 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg n=7 Participants PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 28	1.06 milligram per liter (mg/L) Standard Deviation 5.153	-4.48 milligram per liter (mg/L) Standard Deviation 8.635	-9.98 milligram per liter (mg/L) Standard Deviation 6.168	-6.70 milligram per liter (mg/L) Standard Deviation 8.402	-8.59 milligram per liter (mg/L) Standard Deviation 5.797	-17.52 milligram per liter (mg/L) Standard Deviation 25.634
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Baseline	11.54 milligram per liter (mg/L) Standard Deviation 12.452	9.95 milligram per liter (mg/L) Standard Deviation 7.886	11.01 milligram per liter (mg/L) Standard Deviation 6.419	7.23 milligram per liter (mg/L) Standard Deviation 8.316	8.88 milligram per liter (mg/L) Standard Deviation 5.797	17.91 milligram per liter (mg/L) Standard Deviation 25.572
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 7	-0.09 milligram per liter (mg/L) Standard Deviation 7.128	-6.36 milligram per liter (mg/L) Standard Deviation 8.322	-9.85 milligram per liter (mg/L) Standard Deviation 5.830	-6.43 milligram per liter (mg/L) Standard Deviation 7.766	-8.26 milligram per liter (mg/L) Standard Deviation 5.747	-17.31 milligram per liter (mg/L) Standard Deviation 25.317
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 14	-2.63 milligram per liter (mg/L) Standard Deviation 10.877	-5.81 milligram per liter (mg/L) Standard Deviation 9.019	-10.03 milligram per liter (mg/L) Standard Deviation 6.134	-6.69 milligram per liter (mg/L) Standard Deviation 8.357	-8.56 milligram per liter (mg/L) Standard Deviation 5.827	-17.52 milligram per liter (mg/L) Standard Deviation 25.571
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 35	0.74 milligram per liter (mg/L) Standard Deviation 6.859	-6.51 milligram per liter (mg/L) Standard Deviation 8.817	-11.10 milligram per liter (mg/L) Standard Deviation 6.617	-6.52 milligram per liter (mg/L) Standard Deviation 8.515	-8.63 milligram per liter (mg/L) Standard Deviation 5.824	-17.56 milligram per liter (mg/L) Standard Deviation 25.608
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 42	-0.06 milligram per liter (mg/L) Standard Deviation 6.823	-6.60 milligram per liter (mg/L) Standard Deviation 8.299	-11.02 milligram per liter (mg/L) Standard Deviation 6.653	-6.82 milligram per liter (mg/L) Standard Deviation 8.384	-8.65 milligram per liter (mg/L) Standard Deviation 5.833	-17.59 milligram per liter (mg/L) Standard Deviation 25.614
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 56	-0.07 milligram per liter (mg/L) Standard Deviation 6.724	-6.14 milligram per liter (mg/L) Standard Deviation 8.918	-10.68 milligram per liter (mg/L) Standard Deviation 6.503	-6.65 milligram per liter (mg/L) Standard Deviation 8.453	-8.66 milligram per liter (mg/L) Standard Deviation 5.817	-17.59 milligram per liter (mg/L) Standard Deviation 25.611
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 63	-0.10 milligram per liter (mg/L) Standard Deviation 8.214	-7.83 milligram per liter (mg/L) Standard Deviation 8.284	-11.35 milligram per liter (mg/L) Standard Deviation 6.758	-6.67 milligram per liter (mg/L) Standard Deviation 8.472	-8.68 milligram per liter (mg/L) Standard Deviation 5.812	-17.58 milligram per liter (mg/L) Standard Deviation 25.611
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 70	1.68 milligram per liter (mg/L) Standard Deviation 13.334	-7.67 milligram per liter (mg/L) Standard Deviation 8.263	-11.25 milligram per liter (mg/L) Standard Deviation 6.740	-6.82 milligram per liter (mg/L) Standard Deviation 8.441	-8.69 milligram per liter (mg/L) Standard Deviation 5.810	-17.60 milligram per liter (mg/L) Standard Deviation 25.608
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 84	5.16 milligram per liter (mg/L) Standard Deviation 26.869	-6.23 milligram per liter (mg/L) Standard Deviation 9.130	-10.88 milligram per liter (mg/L) Standard Deviation 6.555	-6.88 milligram per liter (mg/L) Standard Deviation 8.441	-8.54 milligram per liter (mg/L) Standard Deviation 5.760	-17.58 milligram per liter (mg/L) Standard Deviation 25.587
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 129	5.10 milligram per liter (mg/L) Standard Deviation 23.998	-8.49 milligram per liter (mg/L) Standard Deviation 10.327	-10.26 milligram per liter (mg/L) Standard Deviation 5.772	-6.63 milligram per liter (mg/L) Standard Deviation 8.513	-8.65 milligram per liter (mg/L) Standard Deviation 5.840	-17.66 milligram per liter (mg/L) Standard Deviation 25.605
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 174	2.42 milligram per liter (mg/L) Standard Deviation 15.773	-4.55 milligram per liter (mg/L) Standard Deviation 0.735	-8.73 milligram per liter (mg/L) Standard Deviation 4.550	-4.28 milligram per liter (mg/L) Standard Deviation 4.545	-8.57 milligram per liter (mg/L) Standard Deviation 5.781	-17.62 milligram per liter (mg/L) Standard Deviation 25.581
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 219	4.35 milligram per liter (mg/L) Standard Deviation 18.530	4.01 milligram per liter (mg/L) Standard Deviation 10.083	-6.22 milligram per liter (mg/L) Standard Deviation 4.790	-6.40 milligram per liter (mg/L) Standard Deviation 8.602	-8.66 milligram per liter (mg/L) Standard Deviation 5.807	-19.43 milligram per liter (mg/L) Standard Deviation 26.221
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 264	-5.33 milligram per liter (mg/L) Standard Deviation 6.033	-6.30 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-4.06 milligram per liter (mg/L) Standard Deviation 1.961	-2.58 milligram per liter (mg/L) Standard Deviation 1.056	-8.07 milligram per liter (mg/L) Standard Deviation 5.922	-16.60 milligram per liter (mg/L) Standard Deviation 28.318
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 309	-6.19 milligram per liter (mg/L) Standard Deviation 7.987	—	-4.36 milligram per liter (mg/L) Standard Deviation 1.761	-5.80 milligram per liter (mg/L) Standard Deviation 8.951	-7.63 milligram per liter (mg/L) Standard Deviation 6.599	-16.52 milligram per liter (mg/L) Standard Deviation 28.364
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 354	-3.33 milligram per liter (mg/L) Standard Deviation 12.217	—	-2.30 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-5.11 milligram per liter (mg/L) Standard Deviation 9.482	-8.12 milligram per liter (mg/L) Standard Deviation 5.849	-16.61 milligram per liter (mg/L) Standard Deviation 28.313
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 399	-2.49 milligram per liter (mg/L) Standard Deviation 8.119	—	—	-6.47 milligram per liter (mg/L) Standard Deviation 8.596	4.68 milligram per liter (mg/L) Standard Deviation 32.401	-16.56 milligram per liter (mg/L) Standard Deviation 28.330
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 444	-15.00 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	-0.79 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-4.78 milligram per liter (mg/L) Standard Deviation 4.694	-15.57 milligram per liter (mg/L) Standard Deviation 28.927
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 489	-14.38 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	-1.05 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-1.80 milligram per liter (mg/L) Standard Deviation 0.870	-16.47 milligram per liter (mg/L) Standard Deviation 28.357
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 534	-6.82 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	-0.86 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-2.34 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-16.25 milligram per liter (mg/L) Standard Deviation 28.463
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 579	-13.88 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	—	—	-15.81 milligram per liter (mg/L) Standard Deviation 28.620
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 624	—	—	—	—	—	-23.45 milligram per liter (mg/L) Standard Deviation 37.575
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Early Discontinuation	—	—	—	—	—	2.30 milligram per liter (mg/L) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624

Population: Data for this outcome measure was not assessed since this measure was analyzed as per sponsor discretion as the change from baseline in CRP in this study was well demonstrated with the raw CRP data. Therefore, log transformation of CRP was not performed.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation

Population: Pharmacodynamic analysis set included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter.Data collected at Early Discontinuation included those subjects who left the study early. 'N' (number of participants analyzed) = participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=5 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=5 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg n=7 Participants PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 354	1.46 10^3 cells/millimeter (mm)^3 Standard Deviation 0.296	—	-2.02 10^3 cells/millimeter (mm)^3 Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-0.88 10^3 cells/millimeter (mm)^3 Standard Deviation 0.448	-1.33 10^3 cells/millimeter (mm)^3 Standard Deviation 0.624	-0.16 10^3 cells/millimeter (mm)^3 Standard Deviation 0.717
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 84	-0.05 10^3 cells/millimeter (mm)^3 Standard Deviation 0.427	-0.87 10^3 cells/millimeter (mm)^3 Standard Deviation 1.257	-1.77 10^3 cells/millimeter (mm)^3 Standard Deviation 1.138	-0.33 10^3 cells/millimeter (mm)^3 Standard Deviation 1.740	-1.02 10^3 cells/millimeter (mm)^3 Standard Deviation 1.858	-1.24 10^3 cells/millimeter (mm)^3 Standard Deviation 0.719
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 129	1.56 10^3 cells/millimeter (mm)^3 Standard Deviation 2.271	-0.35 10^3 cells/millimeter (mm)^3 Standard Deviation 0.289	-1.40 10^3 cells/millimeter (mm)^3 Standard Deviation 1.424	-0.84 10^3 cells/millimeter (mm)^3 Standard Deviation 1.005	-1.62 10^3 cells/millimeter (mm)^3 Standard Deviation 0.757	-0.60 10^3 cells/millimeter (mm)^3 Standard Deviation 0.458
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 174	0.49 10^3 cells/millimeter (mm)^3 Standard Deviation 1.222	-0.51 10^3 cells/millimeter (mm)^3 Standard Deviation 1.944	-1.27 10^3 cells/millimeter (mm)^3 Standard Deviation 1.468	-0.09 10^3 cells/millimeter (mm)^3 Standard Deviation 2.183	-1.25 10^3 cells/millimeter (mm)^3 Standard Deviation 1.254	-0.58 10^3 cells/millimeter (mm)^3 Standard Deviation 0.254
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 219	0.69 10^3 cells/millimeter (mm)^3 Standard Deviation 1.071	-0.99 10^3 cells/millimeter (mm)^3 Standard Deviation 0.994	-1.11 10^3 cells/millimeter (mm)^3 Standard Deviation 1.111	-0.75 10^3 cells/millimeter (mm)^3 Standard Deviation 0.876	-1.71 10^3 cells/millimeter (mm)^3 Standard Deviation 0.906	-0.82 10^3 cells/millimeter (mm)^3 Standard Deviation 0.667
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 264	0.69 10^3 cells/millimeter (mm)^3 Standard Deviation 0.653	-1.48 10^3 cells/millimeter (mm)^3 Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-0.87 10^3 cells/millimeter (mm)^3 Standard Deviation 0.969	-1.28 10^3 cells/millimeter (mm)^3 Standard Deviation 0.857	-1.36 10^3 cells/millimeter (mm)^3 Standard Deviation 1.237	-0.64 10^3 cells/millimeter (mm)^3 Standard Deviation 0.683
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 309	0.05 10^3 cells/millimeter (mm)^3 Standard Deviation 0.452	—	-2.61 10^3 cells/millimeter (mm)^3 Standard Deviation 0.709	-1.34 10^3 cells/millimeter (mm)^3 Standard Deviation 0.726	-1.01 10^3 cells/millimeter (mm)^3 Standard Deviation 0.990	-0.42 10^3 cells/millimeter (mm)^3 Standard Deviation 0.726
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 399	0.44 10^3 cells/millimeter (mm)^3 Standard Deviation 0.922	—	—	-0.61 10^3 cells/millimeter (mm)^3 Standard Deviation 0.781	0.34 10^3 cells/millimeter (mm)^3 Standard Deviation 2.056	-0.11 10^3 cells/millimeter (mm)^3 Standard Deviation 0.901
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 444	0.47 10^3 cells/millimeter (mm)^3 Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	-0.32 10^3 cells/millimeter (mm)^3 Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-0.96 10^3 cells/millimeter (mm)^3 Standard Deviation 2.067	0.11 10^3 cells/millimeter (mm)^3 Standard Deviation 1.064
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 489	0.68 10^3 cells/millimeter (mm)^3 Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	—	-1.24 10^3 cells/millimeter (mm)^3 Standard Deviation 0.564	0.05 10^3 cells/millimeter (mm)^3 Standard Deviation 0.769
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 534	-0.10 10^3 cells/millimeter (mm)^3 Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	-0.61 10^3 cells/millimeter (mm)^3 Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-1.07 10^3 cells/millimeter (mm)^3 Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-0.22 10^3 cells/millimeter (mm)^3 Standard Deviation 0.685
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 579	0.16 10^3 cells/millimeter (mm)^3 Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	—	—	0.41 10^3 cells/millimeter (mm)^3 Standard Deviation 0.566
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 624	—	—	—	—	—	0.10 10^3 cells/millimeter (mm)^3 Standard Deviation 0.792
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Early Discontinuation	0.00 10^3 cells/millimeter (mm)^3 Standard Deviation 0.498	0.93 10^3 cells/millimeter (mm)^3 Standard Deviation 1.106	-1.00 10^3 cells/millimeter (mm)^3 Standard Deviation 0.899	-0.69 10^3 cells/millimeter (mm)^3 Standard Deviation 1.087	-0.63 10^3 cells/millimeter (mm)^3 Standard Deviation 0.849	-0.07 10^3 cells/millimeter (mm)^3 Standard Deviation 0.948
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Baseline	3.41 10^3 cells/millimeter (mm)^3 Standard Deviation 1.458	4.13 10^3 cells/millimeter (mm)^3 Standard Deviation 1.161	4.35 10^3 cells/millimeter (mm)^3 Standard Deviation 1.203	4.38 10^3 cells/millimeter (mm)^3 Standard Deviation 1.791	4.26 10^3 cells/millimeter (mm)^3 Standard Deviation 1.058	3.13 10^3 cells/millimeter (mm)^3 Standard Deviation 0.950
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 7	0.27 10^3 cells/millimeter (mm)^3 Standard Deviation 0.932	-0.16 10^3 cells/millimeter (mm)^3 Standard Deviation 1.707	-1.61 10^3 cells/millimeter (mm)^3 Standard Deviation 0.936	-0.61 10^3 cells/millimeter (mm)^3 Standard Deviation 0.756	-1.87 10^3 cells/millimeter (mm)^3 Standard Deviation 0.550	-1.08 10^3 cells/millimeter (mm)^3 Standard Deviation 0.671
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 14	0.34 10^3 cells/millimeter (mm)^3 Standard Deviation 0.919	-0.71 10^3 cells/millimeter (mm)^3 Standard Deviation 1.145	-1.34 10^3 cells/millimeter (mm)^3 Standard Deviation 0.586	-0.70 10^3 cells/millimeter (mm)^3 Standard Deviation 0.899	-1.91 10^3 cells/millimeter (mm)^3 Standard Deviation 0.660	-0.78 10^3 cells/millimeter (mm)^3 Standard Deviation 0.588
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 28	0.24 10^3 cells/millimeter (mm)^3 Standard Deviation 0.632	-0.58 10^3 cells/millimeter (mm)^3 Standard Deviation 1.828	-0.56 10^3 cells/millimeter (mm)^3 Standard Deviation 1.278	-0.66 10^3 cells/millimeter (mm)^3 Standard Deviation 0.764	-1.91 10^3 cells/millimeter (mm)^3 Standard Deviation 0.460	-0.60 10^3 cells/millimeter (mm)^3 Standard Deviation 0.637
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 35	0.34 10^3 cells/millimeter (mm)^3 Standard Deviation 0.987	-0.39 10^3 cells/millimeter (mm)^3 Standard Deviation 1.394	-1.92 10^3 cells/millimeter (mm)^3 Standard Deviation 1.051	-1.28 10^3 cells/millimeter (mm)^3 Standard Deviation 0.574	-2.08 10^3 cells/millimeter (mm)^3 Standard Deviation 0.756	-0.70 10^3 cells/millimeter (mm)^3 Standard Deviation 0.859
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 42	0.48 10^3 cells/millimeter (mm)^3 Standard Deviation 0.842	-0.67 10^3 cells/millimeter (mm)^3 Standard Deviation 1.834	-1.19 10^3 cells/millimeter (mm)^3 Standard Deviation 0.763	-0.54 10^3 cells/millimeter (mm)^3 Standard Deviation 1.094	-1.78 10^3 cells/millimeter (mm)^3 Standard Deviation 0.954	-0.83 10^3 cells/millimeter (mm)^3 Standard Deviation 0.617
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 56	0.49 10^3 cells/millimeter (mm)^3 Standard Deviation 1.085	-0.79 10^3 cells/millimeter (mm)^3 Standard Deviation 1.071	-1.75 10^3 cells/millimeter (mm)^3 Standard Deviation 1.024	-1.11 10^3 cells/millimeter (mm)^3 Standard Deviation 0.682	-1.47 10^3 cells/millimeter (mm)^3 Standard Deviation 0.778	-1.27 10^3 cells/millimeter (mm)^3 Standard Deviation 0.674
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 63	-0.45 10^3 cells/millimeter (mm)^3 Standard Deviation 1.683	-1.17 10^3 cells/millimeter (mm)^3 Standard Deviation 1.742	-1.36 10^3 cells/millimeter (mm)^3 Standard Deviation 0.548	-1.23 10^3 cells/millimeter (mm)^3 Standard Deviation 0.872	-1.69 10^3 cells/millimeter (mm)^3 Standard Deviation 0.979	-1.04 10^3 cells/millimeter (mm)^3 Standard Deviation 0.657
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation Change at Day 70	0.57 10^3 cells/millimeter (mm)^3 Standard Deviation 0.883	-1.18 10^3 cells/millimeter (mm)^3 Standard Deviation 1.054	-1.80 10^3 cells/millimeter (mm)^3 Standard Deviation 0.952	-0.48 10^3 cells/millimeter (mm)^3 Standard Deviation 0.746	-2.20 10^3 cells/millimeter (mm)^3 Standard Deviation 1.218	-1.11 10^3 cells/millimeter (mm)^3 Standard Deviation 0.871

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624

Population: Pharmacodynamic analysis set included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. n=participants evaluable for this measure at specified time points for each arm, respectively.

Serum samples were analyzed for IL-6 concentrations using a validated analytical colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) method.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 Participants PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 Participants PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 Participants PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=6 Participants PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg n=7 Participants PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Baseline	12.55 picogram per milliliter (pg/mL) Standard Deviation 14.593	9.11 picogram per milliliter (pg/mL) Standard Deviation 7.204	17.82 picogram per milliliter (pg/mL) Standard Deviation 12.433	3.96 picogram per milliliter (pg/mL) Standard Deviation 3.272	11.75 picogram per milliliter (pg/mL) Standard Deviation 9.797	9.49 picogram per milliliter (pg/mL) Standard Deviation 11.744
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 28	0.45 picogram per milliliter (pg/mL) Standard Deviation 5.383	-2.16 picogram per milliliter (pg/mL) Standard Deviation 5.767	-13.12 picogram per milliliter (pg/mL) Standard Deviation 13.086	-2.40 picogram per milliliter (pg/mL) Standard Deviation 3.272	-9.70 picogram per milliliter (pg/mL) Standard Deviation 9.147	-7.25 picogram per milliliter (pg/mL) Standard Deviation 10.337
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 56	-2.00 picogram per milliliter (pg/mL) Standard Deviation 8.081	-3.04 picogram per milliliter (pg/mL) Standard Deviation 6.583	-16.14 picogram per milliliter (pg/mL) Standard Deviation 12.643	-1.80 picogram per milliliter (pg/mL) Standard Deviation 3.342	-10.19 picogram per milliliter (pg/mL) Standard Deviation 9.797	-7.93 picogram per milliliter (pg/mL) Standard Deviation 11.744
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 84	-0.04 picogram per milliliter (pg/mL) Standard Deviation 14.524	-5.60 picogram per milliliter (pg/mL) Standard Deviation 7.278	-14.96 picogram per milliliter (pg/mL) Standard Deviation 14.406	-2.08 picogram per milliliter (pg/mL) Standard Deviation 3.623	-10.19 picogram per milliliter (pg/mL) Standard Deviation 9.797	-7.29 picogram per milliliter (pg/mL) Standard Deviation 11.313
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 129	-1.25 picogram per milliliter (pg/mL) Standard Deviation 8.691	-1.90 picogram per milliliter (pg/mL) Standard Deviation 9.291	-13.39 picogram per milliliter (pg/mL) Standard Deviation 13.627	-1.89 picogram per milliliter (pg/mL) Standard Deviation 3.907	-10.19 picogram per milliliter (pg/mL) Standard Deviation 9.797	-7.16 picogram per milliliter (pg/mL) Standard Deviation 11.507
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 174	4.53 picogram per milliliter (pg/mL) Standard Deviation 20.905	-4.70 picogram per milliliter (pg/mL) Standard Deviation 14.863	-11.63 picogram per milliliter (pg/mL) Standard Deviation 12.903	-1.34 picogram per milliliter (pg/mL) Standard Deviation 4.056	-10.19 picogram per milliliter (pg/mL) Standard Deviation 9.797	-7.22 picogram per milliliter (pg/mL) Standard Deviation 11.332
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 219	4.51 picogram per milliliter (pg/mL) Standard Deviation 19.163	-2.51 picogram per milliliter (pg/mL) Standard Deviation 16.794	-14.23 picogram per milliliter (pg/mL) Standard Deviation 13.524	-0.77 picogram per milliliter (pg/mL) Standard Deviation 3.830	-10.19 picogram per milliliter (pg/mL) Standard Deviation 9.797	-3.89 picogram per milliliter (pg/mL) Standard Deviation 7.796
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 264	-2.33 picogram per milliliter (pg/mL) Standard Deviation 14.034	-17.94 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-1.03 picogram per milliliter (pg/mL) Standard Deviation 17.395	-1.39 picogram per milliliter (pg/mL) Standard Deviation 2.609	-9.93 picogram per milliliter (pg/mL) Standard Deviation 9.856	-1.33 picogram per milliliter (pg/mL) Standard Deviation 1.905
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 309	-1.36 picogram per milliliter (pg/mL) Standard Deviation 2.356	—	-9.19 picogram per milliliter (pg/mL) Standard Deviation 18.993	-1.67 picogram per milliliter (pg/mL) Standard Deviation 2.506	-8.87 picogram per milliliter (pg/mL) Standard Deviation 10.655	-1.33 picogram per milliliter (pg/mL) Standard Deviation 1.905
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 354	-1.36 picogram per milliliter (pg/mL) Standard Deviation 2.356	—	-20.00 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-2.34 picogram per milliliter (pg/mL) Standard Deviation 3.487	-8.61 picogram per milliliter (pg/mL) Standard Deviation 10.701	-1.33 picogram per milliliter (pg/mL) Standard Deviation 1.905
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 399	-1.36 picogram per milliliter (pg/mL) Standard Deviation 2.356	—	—	2.15 picogram per milliliter (pg/mL) Standard Deviation 4.508	-3.74 picogram per milliliter (pg/mL) Standard Deviation 17.157	-1.33 picogram per milliliter (pg/mL) Standard Deviation 1.905
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 444	-4.08 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	4.69 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-8.19 picogram per milliliter (pg/mL) Standard Deviation 12.557	-0.78 picogram per milliliter (pg/mL) Standard Deviation 1.865
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 489	-4.08 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	-2.51 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-6.31 picogram per milliliter (pg/mL) Standard Deviation 19.778	-0.44 picogram per milliliter (pg/mL) Standard Deviation 2.157
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 534	-4.08 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	-2.51 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-20.93 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	-1.33 picogram per milliliter (pg/mL) Standard Deviation 1.905
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 579	-4.08 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—	—	—	—	-1.33 picogram per milliliter (pg/mL) Standard Deviation 1.905
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 Change at Day 624	—	—	—	—	—	-0.85 picogram per milliliter (pg/mL) Standard Deviation 1.472

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

PF-04236921 1 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PF-04236921 10 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PF-04236921 30 mg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

PF-04236921 100 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

PF-04236921 250 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=9 participants at risk Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 participants at risk PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 participants at risk PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 participants at risk PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=6 participants at risk PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg n=7 participants at risk PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
General disorders Chest pain	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Abscess limb	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Plantar fasciitis	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	Placebo n=9 participants at risk Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 1 mg n=6 participants at risk PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 10 mg n=6 participants at risk PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 30 mg n=6 participants at risk PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 100 mg n=6 participants at risk PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.	PF-04236921 250 mg n=7 participants at risk PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days.
General disorders Pain	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Tinnitus	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 allergic	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Eye pain	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Colonic polyp	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dental caries	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	22.2% 2/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dry mouth	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Periodontal disease	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Feeling cold	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Folliculitis	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	33.3% 3/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral herpes	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Rhinitis	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 3/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Ligament sprain	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Traumatic haematoma	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Urine analysis abnormal	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 potassium decreased	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Hepatic enzyme increased	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Weight decreased	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Decreased appetite	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Hypokalaemia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	33.3% 3/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Neck pain	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Osteopenia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	22.2% 2/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 3/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Haematuria	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Pyuria	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal cyst	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Perineal pain	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Asthma	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Rhinitis allergic	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Ingrowing nail	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Urticaria	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Haematoma	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Orthostatic hypotension	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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