Trial Outcomes & Findings for Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus (NCT NCT01673178)

Last Updated: 2015-02-16

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug 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 events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

107 participants

Primary outcome timeframe

Baseline up to 28 days after last dose

Results posted on

2015-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Study STARTED	22	21	21	22	21
Overall Study COMPLETED	19	19	18	14	19
Overall Study NOT COMPLETED	3	2	3	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Study Lost to Follow-up	0	1	0	0	0
Overall Study Withdrawal by Subject	0	0	1	4	2
Overall Study Protocol Violation	1	1	0	1	0
Overall Study Adverse Event	1	0	0	2	0
Overall Study Other	1	0	2	1	0

Baseline Characteristics

Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.	Total n=107 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 8.0 • n=5 Participants	54.6 years STANDARD_DEVIATION 8.3 • n=7 Participants	53.4 years STANDARD_DEVIATION 9.5 • n=5 Participants	53.0 years STANDARD_DEVIATION 7.4 • n=4 Participants	53.2 years STANDARD_DEVIATION 8.0 • n=21 Participants	53.4 years STANDARD_DEVIATION 8.1 • n=10 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	31 Participants n=10 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	17 Participants n=21 Participants	76 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after last dose

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

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	11 participants	15 participants	10 participants	13 participants	12 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 participants	2 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to Day 49

Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.

Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles \[RBC\] count: less than \[\<\]0.8\*lower limit of normal \[LLN\], platelets: \<0.5\*LLN/greater than \[\>\]1.75\*upper limit of normal \[ULN\], leukocytes: \<0.6\*LLN or \>1.5\*ULN, lymphocytes, total neutrophils: \<0.8\*LLN or \>1.2\*ULN, basophils, eosinophil: \<0.8\*LLN, monocytes: \>1.2\*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>0.3\*ULN, total protein, albumin: \<0.8\*LLN or \>1.2\*ULN); total bilirubin, direct bilirubin, indirect bilirubin: \>1.5\*ULN; Renal Function (blood urea nitrogen, creatinine: \>1.3\*ULN, uric acid: \>1.2\*ULN); Electrolytes (sodium: \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN or \>1.1\*ULN; creatine kinase: \>2.0\*ULN; glucose fasting: \<0.6\*LLN or \>1.5\*ULN, urine white blood corpuscles \[WBC\] and RBC: greater than or equal to (\>=) 20/High Power Field \[HPF\]).

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=20 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Number of Participants With Laboratory Abnormalities	18 participants	17 participants	17 participants	12 participants	15 participants

PRIMARY outcome

Timeframe: Baseline up to Day 49

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

Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of \<40 beats per minute (bpm) or \>120 bpm, supine systolic blood pressure (SBP) of \<90 millimeter of mercury (mmHg), \>=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of \<50 mmHg; \>=20 mmHg maximum increase and decrease from baseline in same posture.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Number of Participants With Clinically Significant Vital Sign Abnormalities Supine SBP: <90 mmHg	1 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Vital Sign Abnormalities Supine DBP: <50 mmHg	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With Clinically Significant Vital Sign Abnormalities Maximum Increase in Supine SBP: >=30 mmHg	1 participants	5 participants	4 participants	6 participants	2 participants
Number of Participants With Clinically Significant Vital Sign Abnormalities Maximum Increase in Supine DBP: >=20 mmHg	2 participants	4 participants	3 participants	1 participants	2 participants
Number of Participants With Clinically Significant Vital Sign Abnormalities Maximum Decrease in Supine SBP: >=30 mmHg	3 participants	2 participants	2 participants	0 participants	0 participants
Number of Participants With Clinically Significant Vital Sign Abnormalities Maximum Decrease in Supine DBP: >=20 mmHg	5 participants	1 participants	4 participants	4 participants	2 participants
Number of Participants With Clinically Significant Vital Sign Abnormalities Supine Pulse Rate: <40 bpm	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Vital Sign Abnormalities Supine Pulse Rate: >120 bpm	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to Day 49

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

Clinically significant ECG findings included PR interval \>=300 milliseconds (msec) or \>=25 percent (%) increase from baseline (if baseline PR interval \>200 msec) or \>=50% increase (if baseline PR interval less than or equal to \[\<=\] 200 msec); QRS interval \>=140 msec or \>=50% increase from baseline; QT interval \>=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to \<480 msec, 480 to \<500 msec, \>=500 msec or \>=30 msec but \<60 msec increase from baseline or \>=60 msec increase from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum QRS complex increase from baseline:>=50%	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum PR interval increase : 25% or 50%	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum QRS complex: >=140 msec	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum PR interval: >=300 msec	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum QTcF interval increase: >= 30 to <60 msec	7 participants	4 participants	1 participants	1 participants	4 participants
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum QT interval: >=500 msec	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum QTcF interval: 450-<480 msec	4 participants	3 participants	3 participants	1 participants	3 participants
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum QTcF interval: 480-<500 msec	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum QTcF interval: >=500 msec	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Electrocardiogram Findings Maximum QTCF interval increase: >=60 msec	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to Day 49

Population: Physical examination data reported in this study was for identification of adverse events and were reported as an adverse event in the adverse event section.

Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

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

Results are reported in micro international units per milliliter (mcIU/mL).

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Thyroid Stimulating Hormone (TSH) Level at Baseline	1.57 mcIU/mL Standard Deviation 0.65	2.14 mcIU/mL Standard Deviation 1.25	1.96 mcIU/mL Standard Deviation 1.06	1.88 mcIU/mL Standard Deviation 1.02	2.06 mcIU/mL Standard Deviation 0.87

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=21 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Thyroid Stimulating Hormone (TSH) Level at Day 1	1.96 mcIU/mL Standard Deviation 0.95	2.19 mcIU/mL Standard Deviation 1.10	2.40 mcIU/mL Standard Deviation 1.40	2.26 mcIU/mL Standard Deviation 1.27	4.21 mcIU/mL Standard Deviation 6.67

PRIMARY outcome

Timeframe: Day 25

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=20 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=15 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Thyroid Stimulating Hormone (TSH) Level at Day 25	2.70 mcIU/mL Standard Deviation 3.68	2.13 mcIU/mL Standard Deviation 1.07	2.43 mcIU/mL Standard Deviation 0.87	2.52 mcIU/mL Standard Deviation 1.38	4.06 mcIU/mL Standard Deviation 5.69

PRIMARY outcome

Timeframe: Day 39

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Thyroid Stimulating Hormone (TSH) Level at Day 39	3.69 mcIU/mL Standard Deviation 8.11	2.08 mcIU/mL Standard Deviation 1.54	2.17 mcIU/mL Standard Deviation 1.12	2.50 mcIU/mL Standard Deviation 1.37	3.10 mcIU/mL Standard Deviation 3.28

PRIMARY outcome

Timeframe: Day 49

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=18 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Thyroid Stimulating Hormone (TSH) Level at Day 49	3.42 mcIU/mL Standard Deviation 7.45	1.98 mcIU/mL Standard Deviation 1.16	2.43 mcIU/mL Standard Deviation 1.78	2.55 mcIU/mL Standard Deviation 1.06	3.10 mcIU/mL Standard Deviation 2.03

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=20 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Phosphate Level at Baseline	4.1 milligram per deciliter (mg/dL) Interval 3.0 to 5.1	3.8 milligram per deciliter (mg/dL) Interval 3.1 to 5.0	3.9 milligram per deciliter (mg/dL) Interval 3.0 to 5.3	4.0 milligram per deciliter (mg/dL) Interval 3.0 to 5.2	4.0 milligram per deciliter (mg/dL) Interval 2.9 to 4.5

PRIMARY outcome

Timeframe: Baseline, Day 8

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=20 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=20 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=17 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Change From Baseline in Phosphate Level at Day 8	-0.2 mg/dL Interval -1.4 to 0.8	-0.4 mg/dL Interval -1.4 to 0.6	0.1 mg/dL Interval -0.8 to 0.6	0.0 mg/dL Interval -1.0 to 0.8	-0.3 mg/dL Interval -1.0 to 1.0

PRIMARY outcome

Timeframe: Baseline, Day 15

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=20 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=16 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=17 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=20 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Change From Baseline in Phosphate Level at Day 15	-0.2 mg/dL Interval -1.2 to 0.8	-0.2 mg/dL Interval -2.3 to 0.7	0.2 mg/dL Interval -1.6 to 1.3	-0.1 mg/dL Interval -0.9 to 0.9	-0.2 mg/dL Interval -0.8 to 0.5

PRIMARY outcome

Timeframe: Baseline, Day 25

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=20 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=17 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=15 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Change From Baseline in Phosphate Level at Day 25	-0.1 mg/dL Interval -1.1 to 0.8	-0.2 mg/dL Interval -1.1 to 0.5	0.2 mg/dL Interval -0.6 to 1.1	0.1 mg/dL Interval -0.6 to 0.8	0.0 mg/dL Interval -0.7 to 0.4

PRIMARY outcome

Timeframe: Baseline, Day 49

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=17 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Change From Baseline in Phosphate Level at Day 49	-0.40 mg/dL Interval -1.5 to 0.3	-0.40 mg/dL Interval -1.4 to 1.0	-0.20 mg/dL Interval -1.2 to 1.2	-0.30 mg/dL Interval -1.1 to 0.7	-0.10 mg/dL Interval -0.9 to 0.9

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=20 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Creatine Phosphokinase (CPK) Level at Baseline	73 units per liter (U/L) Interval 26.0 to 471.0	94 units per liter (U/L) Interval 42.0 to 493.0	94 units per liter (U/L) Interval 38.0 to 399.0	103 units per liter (U/L) Interval 45.0 to 699.0	108 units per liter (U/L) Interval 44.0 to 173.0

PRIMARY outcome

Timeframe: Baseline, Day 8

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=20 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=20 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=17 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8	10 U/L Interval -260.0 to 143.0	32 U/L Interval -21.0 to 850.0	13 U/L Interval -70.0 to 245.0	25 U/L Interval -175.0 to 92.0	13 U/L Interval -27.0 to 7614.0

PRIMARY outcome

Timeframe: Baseline, Day 15

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=20 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=16 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=16 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=20 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15	28 U/L Interval -34.0 to 852.0	20 U/L Interval -34.0 to 629.0	7 U/L Interval -97.0 to 243.0	22 U/L Interval -113.0 to 238.0	18 U/L Interval -62.0 to 248.0

PRIMARY outcome

Timeframe: Baseline, Day 25

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=16 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=15 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=18 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25	-5 U/L Interval -246.0 to 32.0	-6 U/L Interval -38.0 to 48.0	-15 U/L Interval -110.0 to 19.0	-8 U/L Interval -54.0 to 771.0	-3 U/L Interval -90.0 to 39.0

PRIMARY outcome

Timeframe: Baseline, Day 49

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=17 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49	21 U/L Interval -141.0 to 2214.0	40 U/L Interval -30.0 to 494.0	27 U/L Interval -85.0 to 292.0	43 U/L Interval -16.0 to 216.0	10 U/L Interval -62.0 to 139.0

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=21 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline PINP	46.3 nanogram per milliliter (NG/ML) Standard Deviation 15.6	41.7 nanogram per milliliter (NG/ML) Standard Deviation 17.0	44.7 nanogram per milliliter (NG/ML) Standard Deviation 19.4	45.0 nanogram per milliliter (NG/ML) Standard Deviation 19.8	44.6 nanogram per milliliter (NG/ML) Standard Deviation 17.6
Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline CTX	0.35 nanogram per milliliter (NG/ML) Standard Deviation 0.11	0.33 nanogram per milliliter (NG/ML) Standard Deviation 0.16	0.35 nanogram per milliliter (NG/ML) Standard Deviation 0.15	0.38 nanogram per milliliter (NG/ML) Standard Deviation 0.20	0.37 nanogram per milliliter (NG/ML) Standard Deviation 0.19

PRIMARY outcome

Timeframe: Baseline, Day 25

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=20 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=15 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25 PINP	-0.8 percent change Standard Deviation 13.5	-14.5 percent change Standard Deviation 11.0	-13.4 percent change Standard Deviation 13.3	-17.6 percent change Standard Deviation 12.8	-19.8 percent change Standard Deviation 9.2
Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25 CTX	5.2 percent change Standard Deviation 15.5	2.3 percent change Standard Deviation 19.7	8.0 percent change Standard Deviation 23.6	7.3 percent change Standard Deviation 17.7	7.9 percent change Standard Deviation 19.4

PRIMARY outcome

Timeframe: Baseline, Day 39

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39 PINP	-2.8 percent change Standard Deviation 13.6	-9.8 percent change Standard Deviation 12.4	-6.6 percent change Standard Deviation 15.6	-10.3 percent change Standard Deviation 12.8	-11.0 percent change Standard Deviation 13.5
Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39 CTX	-7.3 percent change Standard Deviation 21.7	-4.2 percent change Standard Deviation 21.1	-3.5 percent change Standard Deviation 20.2	-13.1 percent change Standard Deviation 18.2	-3.0 percent change Standard Deviation 31.5

PRIMARY outcome

Timeframe: Baseline, Day 49

Population: Safety analysis set included all participants who receive at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=18 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49 PINP	-3.0 percent change Standard Deviation 16.4	-9.4 percent change Standard Deviation 16.9	-1.3 percent change Standard Deviation 20.3	-4.6 percent change Standard Deviation 15.0	-7.4 percent change Standard Deviation 18.3
Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49 CTX	1.5 percent change Standard Deviation 20.8	7.5 percent change Standard Deviation 30.9	-3.9 percent change Standard Deviation 33.8	-16.6 percent change Standard Deviation 15.3	-5.3 percent change Standard Deviation 25.0

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=21 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline Blood Osteocalcin	18.8 microgram per liter (mcg/l) Standard Deviation 5.4	19.2 microgram per liter (mcg/l) Standard Deviation 5.9	18.5 microgram per liter (mcg/l) Standard Deviation 6.3	20.2 microgram per liter (mcg/l) Standard Deviation 8.2	19.9 microgram per liter (mcg/l) Standard Deviation 7.0
Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline Bone-Specific Alkaline Phosphatase	13.0 microgram per liter (mcg/l) Standard Deviation 5.7	11.7 microgram per liter (mcg/l) Standard Deviation 3.9	11.2 microgram per liter (mcg/l) Standard Deviation 4.8	10.0 microgram per liter (mcg/l) Standard Deviation 3.0	11.2 microgram per liter (mcg/l) Standard Deviation 4.2

PRIMARY outcome

Timeframe: Baseline, Day 25

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=20 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=15 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25 Blood Osteocalcin	-2.4 percent change Standard Deviation 8.2	-12.2 percent change Standard Deviation 9.6	-6.4 percent change Standard Deviation 14.0	-7.1 percent change Standard Deviation 11.2	-4.8 percent change Standard Deviation 8.2
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25 Bone-Specific Alkaline Phosphatase	-4.3 percent change Standard Deviation 14.5	-6.6 percent change Standard Deviation 17.0	-0.4 percent change Standard Deviation 15.4	-5.1 percent change Standard Deviation 16.2	-7.1 percent change Standard Deviation 13.1

PRIMARY outcome

Timeframe: Baseline, Day 39

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39 Blood Osteocalcin	-1.8 percent change Standard Deviation 12.6	-10.7 percent change Standard Deviation 9.1	-11.6 percent change Standard Deviation 12.4	-14.7 percent change Standard Deviation 11.6	-13.4 percent change Standard Deviation 13.3
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39 Bone-Specific Alkaline Phosphatase	-5.0 percent change Standard Deviation 20.7	-5.1 percent change Standard Deviation 11.2	3.0 percent change Standard Deviation 18.9	-13.0 percent change Standard Deviation 19.0	-8.1 percent change Standard Deviation 12.4

PRIMARY outcome

Timeframe: Baseline, Day 49

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=18 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49 Blood Osteocalcin	-4.5 percent change Standard Deviation 11.9	-10.7 percent change Standard Deviation 8.5	-5.1 percent change Standard Deviation 17.1	-11.0 percent change Standard Deviation 9.3	-4.8 percent change Standard Deviation 12.3
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49 Bone-Specific Alkaline Phosphatase	-3.8 percent change Standard Deviation 20.6	-3.9 percent change Standard Deviation 14.4	-0.9 percent change Standard Deviation 13.2	-9.6 percent change Standard Deviation 16.6	0.7 percent change Standard Deviation 27.1

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=21 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline	2.97 units per liter (U/L) Standard Deviation 0.53	2.72 units per liter (U/L) Standard Deviation 0.48	3.10 units per liter (U/L) Standard Deviation 0.73	2.78 units per liter (U/L) Standard Deviation 0.62	3.08 units per liter (U/L) Standard Deviation 0.65

PRIMARY outcome

Timeframe: Baseline, Day 25

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=20 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=15 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25	1.3 percent change Standard Deviation 9.4	-1.7 percent change Standard Deviation 12.6	1.9 percent change Standard Deviation 11.0	-0.4 percent change Standard Deviation 10.6	-1.4 percent change Standard Deviation 10.9

PRIMARY outcome

Timeframe: Baseline, Day 39

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=19 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39	0.5 percent change Standard Deviation 10.7	-0.4 percent change Standard Deviation 11.6	0.2 percent change Standard Deviation 10.0	-2.9 percent change Standard Deviation 9.9	3.7 percent change Standard Deviation 16.2

PRIMARY outcome

Timeframe: Day 49

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=19 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=18 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=14 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=18 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49	-2.4 percent change Standard Deviation 10.2	3.1 percent change Standard Deviation 18.0	-0.8 percent change Standard Deviation 12.0	-0.1 percent change Standard Deviation 9.3	-1.1 percent change Standard Deviation 15.8

PRIMARY outcome

Timeframe: Baseline

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=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline Urine Calcium (n=20, 20, 20, 20, 21)	296.4 milligram per 24 hours (mg/24hr) Standard Deviation 143.4	202.1 milligram per 24 hours (mg/24hr) Standard Deviation 104.5	224.3 milligram per 24 hours (mg/24hr) Standard Deviation 122.2	205.3 milligram per 24 hours (mg/24hr) Standard Deviation 100.1	207.4 milligram per 24 hours (mg/24hr) Standard Deviation 112.9
Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline Urine Phosphate (n=21, 20, 20, 21, 21)	922.1 milligram per 24 hours (mg/24hr) Standard Deviation 430.3	673.2 milligram per 24 hours (mg/24hr) Standard Deviation 228.3	859.1 milligram per 24 hours (mg/24hr) Standard Deviation 318.7	795.4 milligram per 24 hours (mg/24hr) Standard Deviation 294.4	755.3 milligram per 24 hours (mg/24hr) Standard Deviation 292.1

PRIMARY outcome

Timeframe: Day 24

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 Participants PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24 Urine Phosphate (n=18, 16, 16, 15, 18)	18.8 mg/24 hours Standard Deviation 276.0	225.8 mg/24 hours Standard Deviation 283.4	241.6 mg/24 hours Standard Deviation 436.0	244.1 mg/24 hours Standard Deviation 363.4	484.4 mg/24 hours Standard Deviation 514.7
Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24 Urine Calcium (n=17, 17, 16, 15, 19)	-29.3 mg/24 hours Standard Deviation 106.3	-9.1 mg/24 hours Standard Deviation 69.6	38.0 mg/24 hours Standard Deviation 131.9	8.2 mg/24 hours Standard Deviation 69.0	5.1 mg/24 hours Standard Deviation 89.7

PRIMARY outcome

Timeframe: Day 1

Population: Safety Analysis Set included all participants who receive 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

Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=22 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=21 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1 Anti-PF- 05231023 Antibodies (n=21, 21, 22, 21)	0 participants	0 participants	0 participants	0 participants	—
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1 Neutralizing Antibodies (n=0, 0, 0, 1)	NA participants Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.	NA participants Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.	NA participants Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.	0 participants	—

PRIMARY outcome

Timeframe: Day 39

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 specified antibodies for each arm, respectively and "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=14 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39 Anti-PF- 05231023 Antibodies (n=19, 18, 14, 19)	0 participants	0 participants	0 participants	1 participants	—
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39 Neutralizing Antibodies (n=0, 0, 1, 1)	NA participants Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.	NA participants Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.	0 participants	0 participants	—

PRIMARY outcome

Timeframe: Day 49

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=14 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49 Neutralizing Antibodies (n=0, 2, 0, 1)	NA participants Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.	1 participants	NA participants Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.	0 participants	—
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49 Anti-PF- 05231023 Antibodies (n=19, 18, 14, 19)	0 participants	1 participants	0 participants	1 participants	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8

Population: Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=17 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=20 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose PF-05231023 C-Terminus	108100 nanogramhour per milliliter (nghr/mL) Standard Deviation 41048	206200 nanogramhour per milliliter (nghr/mL) Standard Deviation 107110	376600 nanogramhour per milliliter (nghr/mL) Standard Deviation 134870	475600 nanogramhour per milliliter (nghr/mL) Standard Deviation 99316	—
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose PF-05231023 N-Terminus	376100 nanogramhour per milliliter (nghr/mL) Standard Deviation 111420	693400 nanogramhour per milliliter (nghr/mL) Standard Deviation 214250	1508000 nanogramhour per milliliter (nghr/mL) Standard Deviation 253030	2004000 nanogramhour per milliliter (nghr/mL) Standard Deviation 405880	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8

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

Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=21 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose PF-05231023 C-Terminus	0.5 hours Interval 0.5 to 1.0	0.5 hours Interval 0.5 to 11.5	0.5 hours Interval 0.5 to 3.4	0.5 hours Interval 0.5 to 1.03	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose PF-05231023 N-Terminus	1.0 hours Interval 0.5 to 5.6	1.0 hours Interval 0.5 to 11.5	1.0 hours Interval 0.5 to 9.5	1.0 hours Interval 0.5 to 3.5	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8

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

Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=21 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose PF-05231023 C-Terminus	7983 nanogram per milliliter (ng/mL) Standard Deviation 2000	15250 nanogram per milliliter (ng/mL) Standard Deviation 3672	32980 nanogram per milliliter (ng/mL) Standard Deviation 7944	48320 nanogram per milliliter (ng/mL) Standard Deviation 8376	—
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose PF-05231023 N-Terminus	8881 nanogram per milliliter (ng/mL) Standard Deviation 1743	16800 nanogram per milliliter (ng/mL) Standard Deviation 4740	31750 nanogram per milliliter (ng/mL) Standard Deviation 5134	44470 nanogram per milliliter (ng/mL) Standard Deviation 8516	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29

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

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=15 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose PF-05231023 C-Terminus	76520 ng*hr/mL Standard Deviation 26169	136200 ng*hr/mL Standard Deviation 34051	301200 ng*hr/mL Standard Deviation 71897	424700 ng*hr/mL Standard Deviation 97424	—
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose PF-05231023 N-Terminus	467700 ng*hr/mL Standard Deviation 136600	855500 ng*hr/mL Standard Deviation 269920	1860000 ng*hr/mL Standard Deviation 434690	2326000 ng*hr/mL Standard Deviation 433010	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=16 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose PF-05231023 C-Terminus	0.55 hours Interval 0.5 to 1.02	0.53 hours Interval 0.45 to 1.0	0.79 hours Interval 0.48 to 3.5	1.00 hours Interval 0.5 to 1.0	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose PF-05231023 N-Terminus	1.00 hours Interval 0.5 to 4.55	1.00 hours Interval 0.48 to 4.5	1.00 hours Interval 0.5 to 4.5	1.00 hours Interval 0.5 to 4.52	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=16 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose PF-05231023 C-Terminus	7697 ng/mL Standard Deviation 1622	14450 ng/mL Standard Deviation 3428	29610 ng/mL Standard Deviation 5300	42260 ng/mL Standard Deviation 7419	—
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose PF-05231023 N-Terminus	9981 ng/mL Standard Deviation 3406	16900 ng/mL Standard Deviation 3279	33140 ng/mL Standard Deviation 9119	48090 ng/mL Standard Deviation 17688	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29

Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=15 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023 PF-05231023 C-Terminus	0.70 ratio Standard Deviation 0.23	0.65 ratio Standard Deviation 0.20	0.79 ratio Standard Deviation 0.24	0.90 ratio Standard Deviation 0.17	—
Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023 PF-05231023 N-Terminus	1.24 ratio Standard Deviation 0.20	1.28 ratio Standard Deviation 0.31	1.25 ratio Standard Deviation 0.15	1.16 ratio Standard Deviation 0.15	—

SECONDARY outcome

Timeframe: 0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=16 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023 PF-05231023 C-Terminus	0.93 ratio Standard Deviation 0.12	0.96 ratio Standard Deviation 0.20	0.89 ratio Standard Deviation 0.23	0.89 ratio Standard Deviation 0.22	—
Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023 PF-05231023 N-Terminus	1.13 ratio Standard Deviation 0.27	1.04 ratio Standard Deviation 0.17	1.04 ratio Standard Deviation 0.33	1.10 ratio Standard Deviation 0.74	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49

Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=16 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose PF-05231023 C-Terminus	0.0001000 ng/mL Standard Deviation 0.00000	0.0001000 ng/mL Standard Deviation 0.00000	0.0001000 ng/mL Standard Deviation 0.00000	0.0001866 ng/mL Standard Deviation 3.2348	—
Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose PF-05231023 N-Terminus	768.3 ng/mL Standard Deviation 405.33	1213 ng/mL Standard Deviation 585.54	3293 ng/mL Standard Deviation 1287.0	4182 ng/mL Standard Deviation 1646.7	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49

Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=15 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose PF-05231023 C-Terminus	455.8 ng/mL Standard Deviation 156.12	810.7 ng/mL Standard Deviation 203.85	1793 ng/mL Standard Deviation 426.65	2529 ng/mL Standard Deviation 581.04	—
Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose PF-05231023 N-Terminus	2783 ng/mL Standard Deviation 812.93	5091 ng/mL Standard Deviation 1605.8	11060 ng/mL Standard Deviation 2593.9	13840 ng/mL Standard Deviation 2574.9	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=15 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Plasma Decay Half-Life (t1/2) of PF-05231023 PF-05231023 C-Terminus	7.6 hours Standard Deviation 1.0	7.4 hours Standard Deviation 1.3	7.4 hours Standard Deviation 1.2	8.6 hours Standard Deviation 3.5	—
Plasma Decay Half-Life (t1/2) of PF-05231023 PF-05231023 N-Terminus	121.6 hours Standard Deviation 16.5	119.3 hours Standard Deviation 24.5	114.8 hours Standard Deviation 12.5	114.6 hours Standard Deviation 12.0	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49

CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=18 Participants PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=15 Participants PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=19 Participants PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Apparent Clearance (CL) of PF-05231023 PF-05231023 C-Terminus	0.33 liter/hour (L/hr) Standard Deviation 0.09	0.37 liter/hour (L/hr) Standard Deviation 0.08	0.33 liter/hour (L/hr) Standard Deviation 0.09	0.35 liter/hour (L/hr) Standard Deviation 0.08	—
Apparent Clearance (CL) of PF-05231023 PF-05231023 N-Terminus	0.05 liter/hour (L/hr) Standard Deviation 0.02	0.06 liter/hour (L/hr) Standard Deviation 0.02	0.05 liter/hour (L/hr) Standard Deviation 0.01	0.06 liter/hour (L/hr) Standard Deviation 0.01	—

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

PF-05231023 25 mg

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

PF-05231023 50 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

PF-05231023 100 mg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

PF-05231023 150 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=22 participants at risk Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 participants at risk PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 participants at risk PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 participants at risk PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 participants at risk PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Cardiac disorders Sinus tachycardia	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Non-cardiac chest pain	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Hypersensitivity	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Breast mass	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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=22 participants at risk Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 25 mg n=21 participants at risk PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 50 mg n=21 participants at risk PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 100 mg n=22 participants at risk PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.	PF-05231023 150 mg n=21 participants at risk PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Blood and lymphatic system disorders Iron deficiency anaemia	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Tachycardia	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Ocular hyperaemia	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 lower	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.6% 3/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	38.1% 8/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Flatulence	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Frequent bowel movements	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.6% 3/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.1% 2/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Toothache	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Generalised oedema	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Hunger	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Infusion site haematoma	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Vessel puncture site haemorrhage	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Lower respiratory tract infection	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Tooth fracture	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatine phosphokinase increased	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 pressure diastolic increased	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 thyroid stimulating hormone increased	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Electrocardiogram ST segment abnormal	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Electrocardiogram T wave abnormal	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Neutrophil count increased	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count increased	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Gout	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Increased appetite	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Flank pain	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	9.1% 2/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Pain in extremity	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Burning sensation	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dysgeusia	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Libido decreased	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Dysuria	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Erectile dysfunction	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Vaginal haemorrhage	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Wheezing	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Night sweats	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 erythematous	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 papular	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Phlebitis	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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