Trial Outcomes & Findings for An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis (NCT NCT00601484)

NCT ID: NCT00601484

Last Updated: 2021-05-13

Results Overview

Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 65 participants
• Primary outcome timeframe: Baseline, Week 6
• Results posted on: 2021-05-13

Participant Flow

Participant milestones

Measure	Tanezumab A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Overall Study STARTED	34	31
Overall Study Treated	34	30
Overall Study COMPLETED	29	23
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Measure	Tanezumab A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	4	3
Overall Study Lack of Efficacy	0	2
Overall Study Withdrawal by Subject	1	1
Overall Study Randomized, but not treated	0	1

Baseline Characteristics

An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

Baseline characteristics by cohort

Measure	Tanezumab n=34 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=31 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Total n=65 Participants Total of all reporting groups
Age, Continuous	43.5 years STANDARD_DEVIATION 13.9 • n=5 Participants	46.4 years STANDARD_DEVIATION 16.6 • n=7 Participants	44.9 years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Restricted Full Analysis Set(rFAS): All randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows.

Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Average Daily Pain Score at Week 6 Baseline	6.4 units on a scale Standard Deviation 1.39	5.9 units on a scale Standard Deviation 1.15
Change From Baseline in Average Daily Pain Score at Week 6 Change at Week 6	-2.3 units on a scale Standard Deviation 1.88	-1.1 units on a scale Standard Deviation 1.49

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 Change at Week 2	-1.5 units on a scale Standard Deviation 1.64	-0.9 units on a scale Standard Deviation 1.15
Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 Change at Week 4	-2.1 units on a scale Standard Deviation 2.04	-1.0 units on a scale Standard Deviation 1.44
Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 Change at Week 10	-2.2 units on a scale Standard Deviation 1.93	-1.4 units on a scale Standard Deviation 1.87
Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 Change at Week 16	-1.9 units on a scale Standard Deviation 1.92	-1.7 units on a scale Standard Deviation 1.77

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16 Change at Week 2	-23.2 percent change Standard Deviation 26.41	-15.9 percent change Standard Deviation 19.64
Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16 Change at Week 4	-33.3 percent change Standard Deviation 34.52	-17.1 percent change Standard Deviation 24.73
Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16 Change at Week 6	-36.3 percent change Standard Deviation 29.10	-18.3 percent change Standard Deviation 26.88
Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16 Change at Week 10	-35.0 percent change Standard Deviation 32.47	-23.5 percent change Standard Deviation 30.66
Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16 Change at Week 16	-29.5 percent change Standard Deviation 32.45	-28.6 percent change Standard Deviation 30.16

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Baseline	13.8 units on a scale Standard Deviation 2.75	13.2 units on a scale Standard Deviation 3.08
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 2	-2.8 units on a scale Standard Deviation 2.98	-2.1 units on a scale Standard Deviation 2.52
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 4	-3.2 units on a scale Standard Deviation 3.28	-1.9 units on a scale Standard Deviation 2.77
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 6	-2.9 units on a scale Standard Deviation 3.75	-1.2 units on a scale Standard Deviation 3.30
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 10	-2.0 units on a scale Standard Deviation 2.71	-2.1 units on a scale Standard Deviation 3.45
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 16	-3.0 units on a scale Standard Deviation 3.22	-2.2 units on a scale Standard Deviation 2.76

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: RFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 2	-21.0 percent change Standard Deviation 21.07	-16.3 percent change Standard Deviation 21.15
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 4	-23.2 percent change Standard Deviation 24.62	-14.5 percent change Standard Deviation 23.46
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 6	-20.5 percent change Standard Deviation 28.12	-9.3 percent change Standard Deviation 27.01
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 10	-14.1 percent change Standard Deviation 18.01	-15.8 percent change Standard Deviation 28.79
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 Change at Week 16	-21.0 percent change Standard Deviation 22.00	-15.5 percent change Standard Deviation 19.34

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Baseline	14.2 micturitions per 24 hours Standard Deviation 3.81	13.0 micturitions per 24 hours Standard Deviation 4.54
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-1.1 micturitions per 24 hours Standard Deviation 1.84	-1.0 micturitions per 24 hours Standard Deviation 2.54
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-0.8 micturitions per 24 hours Standard Deviation 2.23	-0.5 micturitions per 24 hours Standard Deviation 2.85
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-0.3 micturitions per 24 hours Standard Deviation 3.78	-0.6 micturitions per 24 hours Standard Deviation 3.08
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-0.7 micturitions per 24 hours Standard Deviation 3.99	-0.8 micturitions per 24 hours Standard Deviation 3.05
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-0.5 micturitions per 24 hours Standard Deviation 2.42	-0.9 micturitions per 24 hours Standard Deviation 3.18

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-9.8 percent change Interval -28.0 to 20.7	-7.4 percent change Interval -45.0 to 39.6
Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-8.5 percent change Interval -31.3 to 34.2	-0.1 percent change Interval -40.6 to 56.4
Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-8.9 percent change Interval -33.6 to 101.8	-8.9 percent change Interval -39.9 to 86.7
Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-14.9 percent change Interval -35.5 to 80.9	-9.5 percent change Interval -35.9 to 69.8
Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-5.0 percent change Interval -37.9 to 45.9	-10.2 percent change Interval -34.8 to 57.9

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.

Outcome measures

Measure	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=26 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Baseline	7.1 micturitions per night Standard Deviation 5.37	5.8 micturitions per night Standard Deviation 5.52
Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 2	-1.5 micturitions per night Standard Deviation 4.22	-0.6 micturitions per night Standard Deviation 3.48
Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 4	-1.6 micturitions per night Standard Deviation 4.72	-1.5 micturitions per night Standard Deviation 4.99
Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 6	-1.3 micturitions per night Standard Deviation 3.36	-2.1 micturitions per night Standard Deviation 4.78
Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 10	-1.6 micturitions per night Standard Deviation 4.45	-1.5 micturitions per night Standard Deviation 4.95
Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 16	0.1 micturitions per night Standard Deviation 4.31	-1.6 micturitions per night Standard Deviation 5.82

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.

Outcome measures

Measure	Tanezumab n=29 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=24 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 2	-8.8 percent change Interval -100.0 to 114.3	-14.6 percent change Interval -58.8 to 850.0
Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 4	-12.5 percent change Interval -100.0 to 160.0	-41.4 percent change Interval -100.0 to 400.0
Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 6	-17.7 percent change Interval -95.0 to 166.7	-29.2 percent change Interval -88.0 to 271.4
Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 10	-23.7 percent change Interval -100.0 to 183.3	-25.0 percent change Interval -92.0 to 214.3
Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 Change at Week 16	0.0 percent change Interval -82.4 to 333.3	-40.0 percent change Interval -100.0 to 228.6

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Baseline	0.7 episodes per 24 hours Standard Deviation 1.21	1.0 episodes per 24 hours Standard Deviation 1.98
Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-1.4 episodes per 24 hours Standard Deviation 3.05	-2.0 episodes per 24 hours Standard Deviation 4.23
Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-1.6 episodes per 24 hours Standard Deviation 3.09	-2.1 episodes per 24 hours Standard Deviation 4.83
Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-1.5 episodes per 24 hours Standard Deviation 2.99	-2.4 episodes per 24 hours Standard Deviation 4.95
Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-1.7 episodes per 24 hours Standard Deviation 3.00	-2.1 episodes per 24 hours Standard Deviation 4.62
Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-1.6 episodes per 24 hours Standard Deviation 3.28	-2.4 episodes per 24 hours Standard Deviation 4.94

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable and had data available for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.

Outcome measures

Measure	Tanezumab n=14 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=9 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-97.3 percent change Interval -100.0 to -24.5	-87.6 percent change Interval -100.0 to -17.4
Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-82.5 percent change Interval -100.0 to -31.5	-68.6 percent change Interval -100.0 to 57.2
Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-100.0 percent change Interval -100.0 to -32.2	-70.3 percent change Interval -100.0 to 14.2
Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-96.6 percent change Interval -100.0 to -48.7	-74.3 percent change Interval -100.0 to 5.0
Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-93.5 percent change Interval -100.0 to -30.3	-81.7 percent change Interval -100.0 to -9.5

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet [voluntary] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Baseline	149.9 milliliter (mL)/micturition Standard Deviation 64.65	172.2 milliliter (mL)/micturition Standard Deviation 67.85
Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 2	5.4 milliliter (mL)/micturition Standard Deviation 43.18	1.4 milliliter (mL)/micturition Standard Deviation 41.87
Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 4	2.0 milliliter (mL)/micturition Standard Deviation 36.56	2.6 milliliter (mL)/micturition Standard Deviation 49.90
Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 6	-4.0 milliliter (mL)/micturition Standard Deviation 45.30	-0.4 milliliter (mL)/micturition Standard Deviation 46.31
Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 10	-7.4 milliliter (mL)/micturition Standard Deviation 43.26	-8.4 milliliter (mL)/micturition Standard Deviation 43.07
Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 16	-1.4 milliliter (mL)/micturition Standard Deviation 50.61	-5.6 milliliter (mL)/micturition Standard Deviation 41.48

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet [voluntary] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 10	-2.7 percent change Standard Deviation 26.92	-8.8 percent change Standard Deviation 23.97
Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 2	3.8 percent change Standard Deviation 24.55	-0.1 percent change Standard Deviation 22.07
Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 4	0.3 percent change Standard Deviation 21.29	-0.8 percent change Standard Deviation 28.54
Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 6	-2.8 percent change Standard Deviation 21.58	-2.3 percent change Standard Deviation 29.04
Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 Change at Week 16	-1.5 percent change Standard Deviation 29.52	-5.3 percent change Standard Deviation 23.03

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Baseline	5.4 units on a scale Standard Deviation 1.78	4.7 units on a scale Standard Deviation 1.18
Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 2	-1.4 units on a scale Standard Deviation 1.69	-0.5 units on a scale Standard Deviation 1.13
Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 4	-1.7 units on a scale Standard Deviation 1.96	-0.4 units on a scale Standard Deviation 1.30
Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 6	-1.7 units on a scale Standard Deviation 2.07	-0.2 units on a scale Standard Deviation 1.42
Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 10	-1.6 units on a scale Standard Deviation 2.17	-0.4 units on a scale Standard Deviation 1.58
Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 16	-1.3 units on a scale Standard Deviation 2.09	-0.5 units on a scale Standard Deviation 1.60

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here 'number analyzed' signifies those participants who were evaluable for each specified time points.

Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 2	-26.2 percent change Standard Deviation 31.24	-13.1 percent change Standard Deviation 26.06
Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 4	-32.5 percent change Standard Deviation 37.82	-8.2 percent change Standard Deviation 29.58
Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 6	-29.9 percent change Standard Deviation 37.29	-5.2 percent change Standard Deviation 37.85
Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 10	-25.9 percent change Standard Deviation 44.02	-7.0 percent change Standard Deviation 37.00
Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 Change at Week 16	-23.0 percent change Standard Deviation 41.99	-10.7 percent change Standard Deviation 38.13

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Baseline	8.5 episodes per 24 hours Standard Deviation 4.88	8.7 episodes per 24 hours Standard Deviation 6.75
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-1.7 episodes per 24 hours Standard Deviation 3.49	-0.4 episodes per 24 hours Standard Deviation 2.97
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-1.8 episodes per 24 hours Standard Deviation 2.95	0.1 episodes per 24 hours Standard Deviation 3.39
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-1.9 episodes per 24 hours Standard Deviation 4.74	-0.1 episodes per 24 hours Standard Deviation 3.88
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-1.4 episodes per 24 hours Standard Deviation 5.91	-0.9 episodes per 24 hours Standard Deviation 4.31
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-2.1 episodes per 24 hours Standard Deviation 4.84	-0.7 episodes per 24 hours Standard Deviation 4.12

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.

Outcome measures

Measure	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=27 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-21.5 percent change Interval -100.0 to 90.1	-4.7 percent change Interval -100.0 to 221.0
Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-22.9 percent change Interval -100.0 to 49.4	0.8 percent change Interval -100.0 to 248.7
Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-30.4 percent change Interval -100.0 to 101.8	-1.6 percent change Interval -100.0 to 297.5
Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-19.5 percent change Interval -100.0 to 196.3	-4.8 percent change Interval -100.0 to 242.3
Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-32.1 percent change Interval -100.0 to 98.4	-6.7 percent change Interval -100.0 to 144.7

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep?" Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Baseline	2.3 units on a scale Standard Deviation 0.73	2.1 units on a scale Standard Deviation 0.78
Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-0.5 units on a scale Standard Deviation 0.64	-0.3 units on a scale Standard Deviation 0.51
Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-0.7 units on a scale Standard Deviation 0.76	-0.3 units on a scale Standard Deviation 0.75
Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-0.7 units on a scale Standard Deviation 0.73	-0.4 units on a scale Standard Deviation 0.69
Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-0.7 units on a scale Standard Deviation 0.76	-0.3 units on a scale Standard Deviation 0.86
Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-0.5 units on a scale Standard Deviation 0.68	-0.5 units on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep?" Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=27 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-32.0 percent change Standard Deviation 38.58	-15.5 percent change Standard Deviation 33.54
Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-23.7 percent change Standard Deviation 29.81	-11.6 percent change Standard Deviation 28.42
Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-33.8 percent change Standard Deviation 35.41	-17.4 percent change Standard Deviation 29.31
Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-28.3 percent change Standard Deviation 35.62	-11.2 percent change Standard Deviation 52.83
Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-26.7 percent change Standard Deviation 35.40	-23.8 percent change Standard Deviation 30.31

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores of 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much pain did you experience during or after sexual activity?" Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain.

Outcome measures

Measure	Tanezumab n=16 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Baseline	2.1 units on a scale Standard Deviation 1.03	1.4 units on a scale Standard Deviation 0.84
Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-0.7 units on a scale Standard Deviation 0.99	-0.0 units on a scale Standard Deviation 0.51
Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-0.7 units on a scale Standard Deviation 0.98	-0.4 units on a scale Standard Deviation 0.47
Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-0.7 units on a scale Standard Deviation 1.24	-0.2 units on a scale Standard Deviation 0.50
Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-0.7 units on a scale Standard Deviation 1.40	-0.6 units on a scale Standard Deviation 0.54
Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-0.9 units on a scale Standard Deviation 0.95	-0.0 units on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much pain did you experience during or after sexual activity?" Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline.

Outcome measures

Measure	Tanezumab n=11 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=9 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 2	-28.5 percent change Standard Deviation 36.20	-8.0 percent change Standard Deviation 29.94
Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 4	-35.4 percent change Standard Deviation 35.65	-38.6 percent change Standard Deviation 43.33
Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 6	-31.6 percent change Standard Deviation 54.20	-9.3 percent change Standard Deviation 55.81
Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 10	-19.4 percent change Standard Deviation 83.01	-47.7 percent change Standard Deviation 33.81
Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 Change at Week 16	-43.5 percent change Standard Deviation 38.21	-19.4 percent change Standard Deviation 75.54

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions consisted of 4 ranked answers from 0-never to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16 Baseline	22.8 units on a scale Standard Deviation 3.82	21.1 units on a scale Standard Deviation 3.91
Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16 Change at Week 2	-4.0 units on a scale Standard Deviation 3.95	-3.3 units on a scale Standard Deviation 4.59
Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16 Change at Week 4	-4.4 units on a scale Standard Deviation 5.43	-3.0 units on a scale Standard Deviation 4.06
Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16 Change at Week 6	-5.0 units on a scale Standard Deviation 5.51	-3.6 units on a scale Standard Deviation 4.49
Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16 Change at Week 10	-4.2 units on a scale Standard Deviation 4.87	-3.5 units on a scale Standard Deviation 4.18
Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16 Change at Week 16	-4.3 units on a scale Standard Deviation 5.81	-3.6 units on a scale Standard Deviation 2.96

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions each of 4 ranked answers from 0-never, to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16 Change at Week 2	-17.0 percent change Standard Deviation 16.23	-15.6 percent change Standard Deviation 21.67
Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16 Change at Week 4	-18.9 percent change Standard Deviation 24.33	-14.9 percent change Standard Deviation 19.52
Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16 Change at Week 6	-21.4 percent change Standard Deviation 23.14	-18.5 percent change Standard Deviation 22.38
Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16 Change at Week 10	-17.8 percent change Standard Deviation 20.49	-17.3 percent change Standard Deviation 20.67
Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16 Change at Week 16	-17.9 percent change Standard Deviation 23.81	-18.3 percent change Standard Deviation 14.98

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturnal and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16 Baseline	12.3 units on a scale Standard Deviation 2.25	11.7 units on a scale Standard Deviation 2.52
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16 Change at Week 2	-3.1 units on a scale Standard Deviation 3.02	-1.8 units on a scale Standard Deviation 2.54
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16 Change at Week 4	-3.3 units on a scale Standard Deviation 3.71	-2.1 units on a scale Standard Deviation 2.60
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16 Change at Week 6	-3.2 units on a scale Standard Deviation 3.53	-2.1 units on a scale Standard Deviation 2.80
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16 Change at Week 10	-2.5 units on a scale Standard Deviation 2.23	-2.5 units on a scale Standard Deviation 2.71
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16 Change at Week 16	-2.8 units on a scale Standard Deviation 2.62	-2.3 units on a scale Standard Deviation 3.25

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16 Change at Week 2	-26.0 percent change Standard Deviation 26.02	-14.6 percent change Standard Deviation 21.65
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16 Change at Week 4	-27.2 percent change Standard Deviation 32.99	-18.3 percent change Standard Deviation 22.88
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16 Change at Week 6	-26.4 percent change Standard Deviation 30.04	-18.6 percent change Standard Deviation 25.30
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16 Change at Week 10	-21.2 percent change Standard Deviation 21.68	-23.0 percent change Standard Deviation 25.21
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16 Change at Week 16	-24.6 percent change Standard Deviation 25.00	-18.3 percent change Standard Deviation 26.07

SECONDARY outcome

Timeframe: Week 6, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Participants were asked the following question: "Compared to when you began this trial, how would you rate your interstitial cystitis symptoms now?" Participants responded on a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved and 7 = markedly improved; where higher scores indicated improvement. Participants who responded as 6 (moderately improved) or 7 (markedly improved) were defined as treatment responders. Number of participants with response based on GRA scale for all scale categories were reported in this outcome measure.

Outcome measures

Measure	Tanezumab n=25 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=17 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 6: Markedly worse	0 Participants	1 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 6: Moderately worse	1 Participants	0 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 6: Slightly worse	2 Participants	3 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 6: No change	5 Participants	6 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 6: Slightly improved	7 Participants	5 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 6: Moderately improved	5 Participants	1 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 6: Markedly improved	5 Participants	1 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 16: Moderately worse	2 Participants	1 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 16: Slightly worse	1 Participants	0 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 16: No change	5 Participants	5 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 16: Slightly improved	2 Participants	5 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 16: Moderately improved	5 Participants	2 Participants
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16 Week 16: Markedly improved	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 6, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Participant global satisfaction was assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked the following question: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response was rated on a 5-point scale where 1=extremely dissatisfied (dissatisfy), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied; where higher scores indicated more satisfaction. Number of participants with each response was reported in this outcome measure.

Outcome measures

Measure	Tanezumab n=25 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Patient's Global Satisfaction Assessment Week 6: Extremely satisfied	5 Participants	0 Participants
Patient's Global Satisfaction Assessment Week 6: Satisfied	7 Participants	6 Participants
Patient's Global Satisfaction Assessment Week 6:Neither satisfied nor dissatisfied	7 Participants	4 Participants
Patient's Global Satisfaction Assessment Week 6: Dissatisfied	4 Participants	4 Participants
Patient's Global Satisfaction Assessment Week 6: Extremely dissatisfied	2 Participants	2 Participants
Patient's Global Satisfaction Assessment Week 16: Extremely satisfied	4 Participants	1 Participants
Patient's Global Satisfaction Assessment Week 16: Satisfied	7 Participants	6 Participants
Patient's Global Satisfaction Assessment Week16:Neither satisfied nor dissatisfied	5 Participants	2 Participants
Patient's Global Satisfaction Assessment Week 16: Dissatisfied	2 Participants	2 Participants
Patient's Global Satisfaction Assessment Week 16: Extremely dissatisfied	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 6, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Participant global preference was assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using study medication. Participant reported previous treatment under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery and no treatment. Participants' preference was assessed using following categories: definitely prefer current drug, slightly prefer current drug, no preference, definitely prefer prior treatment and slightly prefer prior treatment. Number of participants under each of the categories was reported in this outcome measure. For previous treatment, a single participant may be represented in more than 1 category.

Outcome measures

Measure	Tanezumab n=25 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: Lifestyle interventions	10 Participants	5 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: Physical therapies	6 Participants	1 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: Toileting programs	1 Participants	0 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: Drug given into bladder	8 Participants	4 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: Drug taken by mouth	18 Participants	10 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: Surgery	2 Participants	2 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: No Treatment	6 Participants	2 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: Definitely prefer current drug	9 Participants	2 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: Slightly prefer current drug	4 Participants	4 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: No preference	9 Participants	5 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 6: Definitely prefer prior treatment	3 Participants	5 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: Lifestyle interventions	10 Participants	5 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: Physical therapies	5 Participants	0 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: Toileting programs	2 Participants	0 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: Drug given into bladder	7 Participants	2 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: Drug taken by mouth	15 Participants	10 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: Surgery	3 Participants	3 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: No Treatment	2 Participants	1 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week16: Definitely prefer current drug	6 Participants	1 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: Slightly prefer current drug	5 Participants	4 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: No preference	4 Participants	3 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week 16: Slightly prefer prior treatment	1 Participants	0 Participants
Patient's Global Preference Assessment at Weeks 6, and 16 Week16: Definitely prefer prior treatment	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 6, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Participant willingness to re-use study medication was assessed using PRTI which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked the following question: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your interstitial cystitis?" Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, and definitely would not want to re-use.

Outcome measures

Measure	Tanezumab n=25 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Patient Willingness to Re-use Medicine Assessment Week 6: Definitely want to re-use	9 Participants	3 Participants
Patient Willingness to Re-use Medicine Assessment Week 6: Might want to re-use	5 Participants	5 Participants
Patient Willingness to Re-use Medicine Assessment Week 6: Not sure	9 Participants	3 Participants
Patient Willingness to Re-use Medicine Assessment Week 6: Might not want to re-use	0 Participants	1 Participants
Patient Willingness to Re-use Medicine Assessment Week 6: Definitely not want to re-use	2 Participants	4 Participants
Patient Willingness to Re-use Medicine Assessment Week 16: Definitely want to re-use	7 Participants	4 Participants
Patient Willingness to Re-use Medicine Assessment Week 16: Might want to re-use	5 Participants	3 Participants
Patient Willingness to Re-use Medicine Assessment Week 16: Not sure	2 Participants	1 Participants
Patient Willingness to Re-use Medicine Assessment Week 16: Might not want to re-use	3 Participants	2 Participants
Patient Willingness to Re-use Medicine Assessment Week 16:Definitely not want re-use	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: rFAS population: all randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows.

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any United States Food and Drug Administration (US FDA) approved commercial product of acetaminophen 500 milligram (mg) tablet/capsule could be taken as rescue medication.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Percentage of Participants Who Use Rescue Medication	48.4 percentage of participants	46.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: rFAS population: all randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows.

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by days rescue medication was used relative to the total number of days participant was in the study.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Ratio of Number of Days Rescue Medication Used	0.00 ratio Interval 0.0 to 0.6	0.00 ratio Interval 0.0 to 0.7

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: rFAS population: All randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows.

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by doses of rescue medication used relative to the total number of days participant was in the study.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Average Number of Doses Per Day of Rescue Medication Used	0.00 doses per day Interval 0.0 to 1.7	0.00 doses per day Interval 0.0 to 0.9

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: rFAS population: All randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows.

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by amount of rescue medication (in mg) relative to the total number of days participant was in the study.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Amount of Rescue Medication Taken Per Day	0.00 mg per day Interval 0.0 to 1657.1	0.00 mg per day Interval 0.0 to 724.0

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: rFAS population: All randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows.

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Time to first dose of rescue medication was defined as the time (in days) from the first dose of study drug to the time of first dose of rescue medication use. Results were normalized by days (time [in days] to first dose of rescue medication) relative to the total number of days participant was in the study and reported in terms of proportion of total days in study.

Outcome measures

Measure	Tanezumab n=31 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Time to First Dose of Rescue Medication as a Proportion of Total Days in Study	0.00 proportion of days Interval 0.0 to 0.9	0.00 proportion of days Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Plasma Total NGF levels were assayed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Urine NGF was not analyzed because no reliable assay method was available for assessing urine NGF.

Outcome measures

Measure	Tanezumab n=30 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=25 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Plasma and Urine Total Nerve Growth Factor (NGF) Concentration Day 1 (pre-dose)	16.47 picogram per milliliter (pg/mL) Standard Deviation 7.38	16.70 picogram per milliliter (pg/mL) Standard Deviation 7.33
Plasma and Urine Total Nerve Growth Factor (NGF) Concentration Week 2	1943.45 picogram per milliliter (pg/mL) Standard Deviation 579.77	17.13 picogram per milliliter (pg/mL) Standard Deviation 7.88
Plasma and Urine Total Nerve Growth Factor (NGF) Concentration Week 4	2654.76 picogram per milliliter (pg/mL) Standard Deviation 913.40	17.34 picogram per milliliter (pg/mL) Standard Deviation 4.86
Plasma and Urine Total Nerve Growth Factor (NGF) Concentration Week 6	2542.80 picogram per milliliter (pg/mL) Standard Deviation 926.78	16.49 picogram per milliliter (pg/mL) Standard Deviation 8.64
Plasma and Urine Total Nerve Growth Factor (NGF) Concentration Week 10	2396.09 picogram per milliliter (pg/mL) Standard Deviation 861.74	13.63 picogram per milliliter (pg/mL) Standard Deviation 6.69
Plasma and Urine Total Nerve Growth Factor (NGF) Concentration Week 16	2202.04 picogram per milliliter (pg/mL) Standard Deviation 1014.21	15.47 picogram per milliliter (pg/mL) Standard Deviation 7.89

SECONDARY outcome

Timeframe: Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

HB-EGF urine concentration (in picogram per milliliter [pg/mL]) at specified time points is reported here.

Outcome measures

Measure	Tanezumab n=32 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=26 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration Day 1 (pre-dose)	108.70 pg/mL Standard Deviation 71.15	114.05 pg/mL Standard Deviation 81.68
Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration Week 2	126.08 pg/mL Standard Deviation 48.30	109.48 pg/mL Standard Deviation 61.93
Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration Week 4	123.59 pg/mL Standard Deviation 73.19	120.09 pg/mL Standard Deviation 62.51
Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration Week 6	119.54 pg/mL Standard Deviation 80.83	114.84 pg/mL Standard Deviation 59.03
Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration Week 10	100.94 pg/mL Standard Deviation 60.87	115.39 pg/mL Standard Deviation 65.66
Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration Week 16	115.72 pg/mL Standard Deviation 55.14	128.60 pg/mL Standard Deviation 75.62

SECONDARY outcome

Timeframe: Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

APF activity was determined using 3 H-thymidine incorporation assay. The results were expressed as the percentage of inhibition of 3 H-thymidine incorporation in epithelial cells from urine specimens in the presence of anti proliferative factor.

Outcome measures

Measure	Tanezumab n=32 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=27 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Anti-Proliferative Factor (APF) Urine Concentration Day 1 (pre-dose)	141.40 percentage of inhibition Standard Deviation 43.33	157.87 percentage of inhibition Standard Deviation 76.65
Anti-Proliferative Factor (APF) Urine Concentration Week 2	157.66 percentage of inhibition Standard Deviation 70.74	156.96 percentage of inhibition Standard Deviation 54.68
Anti-Proliferative Factor (APF) Urine Concentration Week 4	146.25 percentage of inhibition Standard Deviation 39.04	163.80 percentage of inhibition Standard Deviation 72.75
Anti-Proliferative Factor (APF) Urine Concentration Week 6	161.38 percentage of inhibition Standard Deviation 54.52	149.07 percentage of inhibition Standard Deviation 32.81
Anti-Proliferative Factor (APF) Urine Concentration Week 10	144.58 percentage of inhibition Standard Deviation 55.21	162.45 percentage of inhibition Standard Deviation 62.07
Anti-Proliferative Factor (APF) Urine Concentration Week 16	152.55 percentage of inhibition Standard Deviation 56.72	163.02 percentage of inhibition Standard Deviation 59.98

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system and any additional assessments necessary to establish baseline status. Clinically significant change in physical examination was based on investigator's discretion.

Outcome measures

Measure	Tanezumab n=34 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=30 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Number of Participants With Clinically Significant Change From Baseline in Physical Examination	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Clinically significant change in vital signs was based on investigator's discretion.

Outcome measures

Measure	Tanezumab n=34 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=30 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

Clinically significant change in body weight was based on investigator's discretion.

Outcome measures

Measure	Tanezumab n=34 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=30 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Number of Participants With Clinically Significant Change From Baseline in Body Weight	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Neurological examination included the assessment of cranial nerve function, coordination, reflexes, mental state, motor function, proprioception, gait and station, and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation). Clinically significant change in neurologic examination was based on investigator's discretion.

Outcome measures

Measure	Tanezumab n=32 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Clinically significant criteria for ECG abnormality: PR interval (maximum increase from Baseline of >=25% [only if Baseline value was greater than 200 millisecond] or otherwise 50%), QRS complex (maximum increase from Baseline of >=25% [only if Baseline value was greater than 200 millisecond] or otherwise 50%), QT interval, QT interval corrected using the Fridericia's formula (QTcF) (maximum increase from Baseline of >= 30 to <60; or >=60), QT interval corrected using the Bazett's formula (QTcB) (maximum increase from Baseline of >= 30 to <60; or >=60) and RR interval.

Outcome measures

Measure	Tanezumab n=34 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=29 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) PR interval (maximum increase from Baseline of >=25 or 50%)	0 Participants	0 Participants
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) QRS complex (maximum increase from Baseline of >=25 or 50%)	0 Participants	0 Participants
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) QTcB (maximum increase from Baseline of >= 30 to <60)	4 Participants	2 Participants
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) QTcB (maximum increase from Baseline of >=60)	0 Participants	0 Participants
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) QTcF (maximum increase from Baseline of >= 30 to <60)	0 Participants	0 Participants
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) QTcF (maximum increase from Baseline of >=60)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 6, 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Number analyzed' = participants with available data for each specified category.

PVR volume is an objective assessment of the amount of urine (in milliliter) left in the bladder after normal urination and monitored whether the active treatment had an adverse effect on lower urinary tract voiding function. The PVR volume was assessed using trans-abdominal ultrasound (for example, bladder scanner) with the participant in a supine position immediately after voluntary urination.

Outcome measures

Measure	Tanezumab n=34 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=30 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Post-void Residual (PVR) Volume Baseline	28.8 milliliter Standard Deviation 32.68	40.2 milliliter Standard Deviation 48.25
Post-void Residual (PVR) Volume Week 2	25.9 milliliter Standard Deviation 34.24	33.5 milliliter Standard Deviation 48.62
Post-void Residual (PVR) Volume Week 6	34.4 milliliter Standard Deviation 35.26	38.6 milliliter Standard Deviation 61.56
Post-void Residual (PVR) Volume Week 16	49.4 milliliter Standard Deviation 56.82	21.8 milliliter Standard Deviation 38.81

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: <0.8*lower limit of normal (LLN); reticulocytes count (absolute or percent): <0.5*LLN or greater than (>) 1.5*upper limit of normal (ULN); Platelets: <0.5*LLN or >1.75*ULN; white blood cell count: <0.6*LLN or >1.5*ULN; neutrophils (absolute or percent): <0.8*LLN or >1.2*ULN; basophils (absolute or percent): >1.2*ULN; lymphocytes (absolute or percent): <0.8*LLN or >1.2*ULN; monocytes (absolute or percent): >1.2*ULN. Serum Chemistry parameters: sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, bicarbonate, calcium: <0.9*LLN or >1.1*ULN; magnesium: >1.1*ULN or <0.9*LLN; BUN (blood urea nitrogen): >1.3* ULN, creatinine: >1.3*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : >3.0*ULN ; total bilirubin: >1.5*ULN; albumin: <0.8*LLN or >1.2*ULN and glucose: <0.6*LLN or >1.5*ULN.

Outcome measures

Measure	Tanezumab n=32 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=28 Participants A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Number of Participants With Laboratory Abnormalities	23 Participants	18 Participants

SECONDARY outcome

Timeframe: Day 1, Week 4, 6, 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for placebo group.

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	Tanezumab n=32 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Number of Participants With Presence of Anti-Drug Antibody (ADA) Week 4	0 Participants	—
Number of Participants With Presence of Anti-Drug Antibody (ADA) Day 1	0 Participants	—
Number of Participants With Presence of Anti-Drug Antibody (ADA) Week 6	0 Participants	—
Number of Participants With Presence of Anti-Drug Antibody (ADA) Week 16	0 Participants	—

SECONDARY outcome

Timeframe: 0 hour (pre-dose), 1, 2 hours post-dose on Day 1; and at Week 2, 4, 6, 10, 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for placebo group.

Outcome measures

Measure	Tanezumab n=32 Participants A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Plasma Concentration of Tanezumab Day 1 0 hour pre-dose	82.25 nanogram per milliliter (ng/mL) Standard Deviation 435.80	—
Plasma Concentration of Tanezumab Day 1 1 hour post-dose	6070.81 nanogram per milliliter (ng/mL) Standard Deviation 2521.35	—
Plasma Concentration of Tanezumab Day 1 2 hour post-dose	5520.63 nanogram per milliliter (ng/mL) Standard Deviation 1558.81	—
Plasma Concentration of Tanezumab Week 2	1885.34 nanogram per milliliter (ng/mL) Standard Deviation 403.93	—
Plasma Concentration of Tanezumab Week 4	1214.59 nanogram per milliliter (ng/mL) Standard Deviation 410.16	—
Plasma Concentration of Tanezumab Week 6	888.70 nanogram per milliliter (ng/mL) Standard Deviation 311.17	—
Plasma Concentration of Tanezumab Week 10	338.10 nanogram per milliliter (ng/mL) Standard Deviation 144.84	—
Plasma Concentration of Tanezumab Week 16	104.07 nanogram per milliliter (ng/mL) Standard Deviation 99.37	—

Adverse Events

Tanezumab

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tanezumab n=34 participants at risk A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=30 participants at risk A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Ear and labyrinth disorders Vertigo	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Hepatobiliary disorders Cholelithiasis	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Urinary tract infection	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Urosepsis	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications Drug exposure during pregnancy	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Transient ischaemic attack	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Reproductive system and breast disorders Ovarian mass	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.

Other adverse events

Measure	Tanezumab n=34 participants at risk A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	Placebo n=30 participants at risk A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.
Blood and lymphatic system disorders Anaemia	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Cardiac disorders Palpitations	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Ear and labyrinth disorders Ear pruritus	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Ear and labyrinth disorders Tympanic membrane perforation	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Eye disorders Altered visual depth perception	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Eye disorders Blepharospasm	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Eye disorders Vision blurred	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Gastrointestinal disorders Abdominal distension	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Gastrointestinal disorders Colitis	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Gastrointestinal disorders Constipation	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Gastrointestinal disorders Diarrhoea	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	10.0% 3/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Gastrointestinal disorders Dry mouth	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Gastrointestinal disorders Faeces discoloured	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Gastrointestinal disorders Nausea	5.9% 2/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	10.0% 3/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Gastrointestinal disorders Vomiting	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	6.7% 2/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
General disorders Chest pain	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
General disorders Chills	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
General disorders Fatigue	8.8% 3/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
General disorders Feeling hot	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
General disorders Influenza like illness	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
General disorders Irritability	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
General disorders Oedema peripheral	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
General disorders Pyrexia	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
General disorders Swelling	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Immune system disorders Anaphylactic reaction	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Bronchitis	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	6.7% 2/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Herpes simplex	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Influenza	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Pharyngitis streptococcal	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Pneumonia	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Sinusitis	5.9% 2/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Streptococcal infection	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Tooth abscess	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Tooth infection	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Upper respiratory tract infection	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Urinary tract infection	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Viral upper respiratory tract infection	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Infections and infestations Vulvovaginal candidiasis	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications Contusion	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications Excoriation	5.9% 2/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications Fall	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications Foot fracture	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications Joint injury	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications Meniscus lesion	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications Muscle strain	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Investigations Alanine aminotransferase increased	5.9% 2/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Investigations Aspartate aminotransferase increased	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Investigations Blood alkaline phosphatase increased	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Investigations Blood creatine phosphokinase increased	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Investigations Blood glucose increased	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Investigations Hepatic enzyme increased	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Metabolism and nutrition disorders Hypokalaemia	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders Arthralgia	8.8% 3/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders Back pain	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	6.7% 2/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders Myalgia	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders Pain in extremity	8.8% 3/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders Tendon pain	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Dizziness	5.9% 2/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Formication	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Headache	20.6% 7/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	16.7% 5/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Hyperaesthesia	8.8% 3/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Hyperreflexia	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Memory impairment	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Neuropathy peripheral	5.9% 2/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Paraesthesia	17.6% 6/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Peripheral motor neuropathy	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Peripheral sensory neuropathy	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Restless legs syndrome	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Sciatica	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Sensory loss	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Nervous system disorders Tongue paralysis	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Psychiatric disorders Anxiety	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Renal and urinary disorders Bladder pain	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	6.7% 2/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Renal and urinary disorders Haematuria	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Renal and urinary disorders Micturition urgency	5.9% 2/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Reproductive system and breast disorders Dysmenorrhoea	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Reproductive system and breast disorders Pelvic pain	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Reproductive system and breast disorders Perineal cyst	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Reproductive system and breast disorders Vulvovaginal discomfort	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Cough	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Sinus congestion	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders Increased tendency to bruise	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders Palmar erythema	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	3.3% 1/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Surgical and medical procedures Endodontic procedure	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Vascular disorders Hot flush	5.9% 2/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Vascular disorders Hypertension	0.00% 0/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	6.7% 2/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.
Vascular disorders Phlebitis	2.9% 1/34 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.	0.00% 0/30 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Analysis performed on safety analysis set.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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