Trial Outcomes & Findings for Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients (NCT NCT00960804)

Last Updated: 2021-02-08

Results Overview

5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency \[MNDL\],peroneal nerve compound muscle action potential\[CMAP\],peroneal motor nerve conduction velocity\[MNCV\],tibial MNDL,sural sensory nerve action potential amplitude \[SNAP\])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score \>0=worse response,less than(\<)0=better response compared to normal matched population.Score change\>0=worsening,\<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

21 participants

Primary outcome timeframe

A4091026: Baseline, A4091040: Week 24

Results posted on

2021-02-08

Participant Flow

Participants who received study drug and had end of study nerve function assessment data in previous study A4091026 (NCT00863772) were eligible to be enrolled in this study. Dosing interval between last dose in A4091026 (NCT00863772) and first dose in this study was not less than 8 weeks or more than 12 weeks.

Participant milestones

Participant milestones
Measure	Tanezumab 5 mg + Standard of Care Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Overall Study STARTED	7	4	10
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	7	4	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanezumab 5 mg + Standard of Care Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	1	0	0
Overall Study Study terminated by the sponsor	5	4	10

Baseline Characteristics

Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Total n=21 Participants Total of all reporting groups
Age, Customized 45 to 64 years	7 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Age, Customized Greater than or equal to (>=) 65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants

PRIMARY outcome

Timeframe: A4091026: Baseline, A4091040: Week 24

Population: Intent-to-treat (ITT) analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using last observation carried forward (LOCF) method.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate and Heart Rate-Deep Breathing, Normal Deviate (5NC [nd] + HRdb-[nd]) Composite Score at Week 24 Baseline	1.37 normal deviate score Standard Deviation 3.19	2.96 normal deviate score Standard Deviation 1.02	0.31 normal deviate score Standard Deviation 2.76
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate and Heart Rate-Deep Breathing, Normal Deviate (5NC [nd] + HRdb-[nd]) Composite Score at Week 24 Change at Week 24	0.28 normal deviate score Standard Deviation 2.57	1.79 normal deviate score Standard Deviation 2.70	-1.40 normal deviate score Standard Deviation 2.83

SECONDARY outcome

Timeframe: A4091026: Baseline, A4091040: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

NIS-LL:assess muscle weakness, reflexes, sensation;scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion,hip and knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors) scored on scale 0(normal) to 4(paralysis),higher score=greater weakness. Components of reflexes(quadriceps femoris,triceps surae);sensation (touch pressure,pin-prick,vibration,joint position) scored 0=normal,1=decreased, or 2=absent. NIS-LL score: sum of scores of NIS items 17-24, 28-29 and 34-37. Total possible NIS-LL score range 0-88,high score=more impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) at Week 24 Baseline	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) at Week 24 Change at Week 24	1.14 units on a scale Standard Deviation 3.02	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: A4091026: Baseline, A4091040: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score (NIS) at Week 24 Change at Week 24	2.00 units on a scale Standard Deviation 5.29	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score (NIS) at Week 24 Baseline	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: A4091026: Baseline, A4091040: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

NSC score is the number of the 38 symptom questions where the participants indicated experiencing the symptom to any severity. Total score range: 0 to 38 where higher score indicated more symptoms.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24 Change at Week 24	0.00 units on a scale Standard Deviation 0.00	0.25 units on a scale Standard Deviation 0.50	0.10 units on a scale Standard Deviation 0.32
Change From A4091026 (NCT00863772) Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24 Baseline	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00

OTHER_PRE_SPECIFIED outcome

Timeframe: A4091026: Baseline, A4091040: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.

5NC (nd) score included five NCS attributes: peroneal MNDL, CMAP, MNCV; tibial MNDL; sural SNAP. Values of attributes scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as nd score based on standard normal distribution. For CMAP, MNCV, SNAP: score \<0 indicated worse and \>0 indicated better response; for peroneal,tibial MNDL: score \>0 indicated worse and \<0 indicated better response, as compared to normal matched population. For CMAP, MNCV, SNAP: score change \<0 indicated worsening and \>0 indicated improvement; for peroneal,tibial MNDL: score change \>0 indicated worsening and \<0 indicated improvement, as compared to baseline. Total score calculated as sum of each NCS attribute. Total score \>0 indicated worse and \<0 indicated better response as compared to normal matched population. Total score change \>0 indicated worsening and \<0 indicated improvement as compared to baseline.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Baseline: Peroneal CMAP	-0.20 normal deviate score Standard Deviation 1.16	-0.85 normal deviate score Standard Deviation 0.45	0.13 normal deviate score Standard Deviation 1.27
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Baseline: Peroneal MNDL	-0.14 normal deviate score Standard Deviation 0.70	0.33 normal deviate score Standard Deviation 0.51	-0.09 normal deviate score Standard Deviation 0.93
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Baseline: Tibial MNDL	0.82 normal deviate score Standard Deviation 1.24	1.41 normal deviate score Standard Deviation 1.12	0.97 normal deviate score Standard Deviation 0.61
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Baseline: Sural SNAP	-0.95 normal deviate score Standard Deviation 0.95	-0.80 normal deviate score Standard Deviation 1.04	-0.72 normal deviate score Standard Deviation 1.14
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Baseline: 5NC (nd) composite score	1.21 normal deviate score Standard Deviation 2.90	2.37 normal deviate score Standard Deviation 1.38	0.69 normal deviate score Standard Deviation 2.71
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Change at Week 24: Peroneal CMAP	-1.03 normal deviate score Standard Deviation 1.33	-0.32 normal deviate score Standard Deviation 0.45	-0.02 normal deviate score Standard Deviation 0.75
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Change at Week 24: Peroneal MNDL	-0.06 normal deviate score Standard Deviation 1.34	-0.82 normal deviate score Standard Deviation 0.40	-0.08 normal deviate score Standard Deviation 0.71
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Change at Week 24: Tibial MNDL	-0.89 normal deviate score Standard Deviation 1.42	-0.38 normal deviate score Standard Deviation 0.39	-0.59 normal deviate score Standard Deviation 1.15
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Change at Week 24: Sural SNAP	-0.29 normal deviate score Standard Deviation 0.78	-0.49 normal deviate score Standard Deviation 0.57	0.14 normal deviate score Standard Deviation 1.01
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Change at Week 24:5NC(nd) composite score	0.53 normal deviate score Standard Deviation 2.21	1.33 normal deviate score Standard Deviation 2.96	-0.96 normal deviate score Standard Deviation 2.40
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Baseline: Peroneal MNCV	0.61 normal deviate score Standard Deviation 1.55	1.03 normal deviate score Standard Deviation 1.02	0.77 normal deviate score Standard Deviation 1.78
Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 Change at Week 24: Peroneal MNCV	-0.16 normal deviate score Standard Deviation 0.81	-0.50 normal deviate score Standard Deviation 0.40	0.16 normal deviate score Standard Deviation 1.19

OTHER_PRE_SPECIFIED outcome

Timeframe: A4091026: Baseline, A4091040: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

HRdb test was used to evaluate the effect of treatment on autonomic function. Participant took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as normal deviates. Score \<0 indicated worse response and \>0 indicated better response as compared to normal matched population. Score change \<0 indicated worsening and \>0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Measurements were collected twice and highest nd score was selected at each NV. Mean of the selected measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in Heart Rate-Deep Breathing, Normal Deviate (HRdb, [nd]) Score at Week 24 Baseline	-0.16 normal deviate score Standard Deviation 0.59	-0.59 normal deviate score Standard Deviation 0.36	0.38 normal deviate score Standard Deviation 1.15
Change From A4091026 (NCT00863772) Baseline in Heart Rate-Deep Breathing, Normal Deviate (HRdb, [nd]) Score at Week 24 Change at Week 24	0.25 normal deviate score Standard Deviation 0.53	-0.17 normal deviate score Standard Deviation 0.35	-0.21 normal deviate score Standard Deviation 0.54

OTHER_PRE_SPECIFIED outcome

Timeframe: A4091026: Baseline, A4091040: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

IENF density was quantified in 3 millimeter (mm) immunostained (PGP 9.5 immunohistochemical staining) skin punch biopsies taken from the distal end of the leg, 10 centimeter (cm) above the lateral malleolus, within the territory of the sural nerve, containing epidermis and superficial dermis to evaluate amount of small diameter nerve fibers. Skin biopsies were taken from normal appearing skin and skin having local scar, signs of trauma, ulceration, or active dermatologic process were avoided.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in Intraepidermal Nerve Fiber Density (IENF) at Week 24 Baseline	13.01 nerve fiber count/millimeter Standard Deviation 6.54	8.99 nerve fiber count/millimeter Standard Deviation 5.79	9.75 nerve fiber count/millimeter Standard Deviation 4.46
Change From A4091026 (NCT00863772) Baseline in Intraepidermal Nerve Fiber Density (IENF) at Week 24 Change at Week 24	-0.90 nerve fiber count/millimeter Standard Deviation 3.02	0.07 nerve fiber count/millimeter Standard Deviation 1.47	0.67 nerve fiber count/millimeter Standard Deviation 4.26

OTHER_PRE_SPECIFIED outcome

Timeframe: A4091026: Baseline, A4091040: Week 8, 16, 24, 32

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. Results were not reported at Week 32 as none of the participants were evaluable for this measure at Week 32.

WOMAC Index: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items), and physical function (17 items) in participants with osteoarthritis of the index hip or index knee. Each question was assessed on Numeric Rating Scale (NRS) as 0(none) to 10(extreme).Total possible domain score was calculated as the mean of the score for each domain questions. Score range:0-10,high scores=high pain/stiffness/difficulty in physical activity.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Baseline: Pain	5.66 units on a scale Standard Deviation 2.03	6.75 units on a scale Standard Deviation 1.04	6.70 units on a scale Standard Deviation 1.85
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Baseline: Physical Function	6.01 units on a scale Standard Deviation 1.50	6.88 units on a scale Standard Deviation 0.92	6.73 units on a scale Standard Deviation 1.94
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Baseline: Stiffness	6.64 units on a scale Standard Deviation 1.97	6.88 units on a scale Standard Deviation 0.25	6.65 units on a scale Standard Deviation 2.00
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Change at Week 8: Pain	-3.20 units on a scale Standard Deviation 2.61	-4.45 units on a scale Standard Deviation 3.23	-2.76 units on a scale Standard Deviation 2.03
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Change at Week 8: Physical Function	-3.38 units on a scale Standard Deviation 2.50	-4.60 units on a scale Standard Deviation 2.88	-2.24 units on a scale Standard Deviation 1.78
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Change at Week 8: Stiffness	-3.86 units on a scale Standard Deviation 3.01	-4.75 units on a scale Standard Deviation 2.96	-2.25 units on a scale Standard Deviation 2.84
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Change at Week 16: Pain	-2.91 units on a scale Standard Deviation 2.66	-5.05 units on a scale Standard Deviation 2.04	-2.84 units on a scale Standard Deviation 2.00
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Change at Week 16: Physical Function	-3.26 units on a scale Standard Deviation 2.46	-5.22 units on a scale Standard Deviation 1.66	-2.42 units on a scale Standard Deviation 2.04
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Change at Week 16: Stiffness	-3.79 units on a scale Standard Deviation 2.91	-5.25 units on a scale Standard Deviation 2.02	-2.50 units on a scale Standard Deviation 2.89
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Change at Week 24: Pain	-2.91 units on a scale Standard Deviation 2.66	-5.05 units on a scale Standard Deviation 2.04	-2.82 units on a scale Standard Deviation 2.00
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Change at Week 24: Physical Function	-3.26 units on a scale Standard Deviation 2.46	-5.22 units on a scale Standard Deviation 1.66	-2.42 units on a scale Standard Deviation 2.03
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 Change at Week 24: Stiffness	-3.79 units on a scale Standard Deviation 2.91	-5.25 units on a scale Standard Deviation 2.02	-2.50 units on a scale Standard Deviation 2.89

OTHER_PRE_SPECIFIED outcome

Timeframe: A4091026: Baseline, A4091040: Week 8, 16, 24, 32

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. Results were not reported at Week 32 as none of the participants were evaluable for this measure at Week 32.

PGA: Participants answered the following question: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants rated their condition using a 5-point Likert scale. Score range: 1 to 5. 1: Very Good (asymptomatic and no limitation of normal activities); 2: Good (mild symptoms and no limitation of normal activities); 3: Fair (moderate symptoms and limitation of some normal activites); 4: Poor (severe symptoms and inability to carry out most normal activities); 5: Very Poor (very severe symptoms which are intolerable and inability to carry out all normal activities).

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 8, 16, 24 and 32 Baseline	3.00 units on a scale Standard Deviation 0.00	3.50 units on a scale Standard Deviation 0.58	3.70 units on a scale Standard Deviation 0.82
Change From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 8, 16, 24 and 32 Change at Week 8	-0.86 units on a scale Standard Deviation 1.07	-2.00 units on a scale Standard Deviation 0.00	-1.10 units on a scale Standard Deviation 1.10
Change From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 8, 16, 24 and 32 Change at Week 16	-1.00 units on a scale Standard Deviation 1.00	-2.00 units on a scale Standard Deviation 0.00	-1.20 units on a scale Standard Deviation 0.92
Change From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 8, 16, 24 and 32 Change at Week 24	-1.00 units on a scale Standard Deviation 1.00	-2.00 units on a scale Standard Deviation 0.00	-1.30 units on a scale Standard Deviation 0.82

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8, 16, 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

OMERACT-OARSI response: \>=50 percent (%) improvement from A4091026 (NCT00863772) baseline and absolute change from A4091026 (NCT00863772) baseline of \>=2 units at week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: \>=20% improvement from A4091026 (NCT00863772) baseline and absolute change from A4091026 (NCT00863772) baseline of \>=1 unit at week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 8	85.7 percentage of participants	75.0 percentage of participants	70.0 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 16	85.7 percentage of participants	100.0 percentage of participants	70.0 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 24	85.7 percentage of participants	100.0 percentage of participants	70.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: A4091026: Baseline, A4091040: Week 8, 16, 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response. Change from baseline \<0 indicates an improvement.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 8, 16 and 24 Baseline	6.10 units on a scale Standard Deviation 1.71	6.83 units on a scale Standard Deviation 0.67	6.69 units on a scale Standard Deviation 1.88
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 8, 16 and 24 Change at Week 8	-3.48 units on a scale Standard Deviation 2.58	-4.60 units on a scale Standard Deviation 2.99	-2.42 units on a scale Standard Deviation 2.15
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 8, 16 and 24 Change at Week 16	-3.32 units on a scale Standard Deviation 2.56	-5.17 units on a scale Standard Deviation 1.85	-2.59 units on a scale Standard Deviation 2.23
Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 8, 16 and 24 Change at Week 24	-3.32 units on a scale Standard Deviation 2.56	-5.17 units on a scale Standard Deviation 1.85	-2.58 units on a scale Standard Deviation 2.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8, 16, 24, 32

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=70% Reduction	42.9 percentage of participants	75.0 percentage of participants	20.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=30% Reduction	71.4 percentage of participants	75.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=50% Reduction	42.9 percentage of participants	75.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=30% Reduction	85.7 percentage of participants	75.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=50% Reduction	42.9 percentage of participants	75.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=70% Reduction	42.9 percentage of participants	75.0 percentage of participants	10.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=90% Reduction	14.3 percentage of participants	50.0 percentage of participants	10.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=90% Reduction	14.3 percentage of participants	50.0 percentage of participants	10.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 24: >=30% Reduction	71.4 percentage of participants	75.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 24: >=50% Reduction	42.9 percentage of participants	75.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 24: >=70% Reduction	42.9 percentage of participants	75.0 percentage of participants	20.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 24: >=90% Reduction	14.3 percentage of participants	50.0 percentage of participants	10.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 32: >=30% Reduction	71.4 percentage of participants	75.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 32: >=50% Reduction	42.9 percentage of participants	75.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 32: >=70% Reduction	42.9 percentage of participants	75.0 percentage of participants	20.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 32: >=90% Reduction	14.3 percentage of participants	50.0 percentage of participants	10.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8, 16, 24, 32

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Percentage of Participants With Improvement of At Least 2 Points From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Week 8	0 percentage of participants	0 percentage of participants	10.0 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Week 16	0 percentage of participants	0 percentage of participants	10.0 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Week 24	0 percentage of participants	0 percentage of participants	20.0 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Week 32	0 percentage of participants	0 percentage of participants	20.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: A4091026: Baseline, A4091040: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: General Health	67.71 units on a scale Standard Deviation 16.18	79.50 units on a scale Standard Deviation 9.57	77.40 units on a scale Standard Deviation 9.61
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Physical Function	55.00 units on a scale Standard Deviation 24.15	47.50 units on a scale Standard Deviation 35.24	39.00 units on a scale Standard Deviation 23.43
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Role Physical	66.96 units on a scale Standard Deviation 23.31	53.13 units on a scale Standard Deviation 36.98	34.38 units on a scale Standard Deviation 26.88
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Bodily Pain	51.14 units on a scale Standard Deviation 25.20	42.25 units on a scale Standard Deviation 22.54	33.50 units on a scale Standard Deviation 19.05
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Vitality	54.46 units on a scale Standard Deviation 21.56	59.38 units on a scale Standard Deviation 15.73	61.88 units on a scale Standard Deviation 24.02
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Social Function	82.14 units on a scale Standard Deviation 20.23	78.13 units on a scale Standard Deviation 25.77	82.50 units on a scale Standard Deviation 17.87
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Role Emotional	79.76 units on a scale Standard Deviation 20.33	79.17 units on a scale Standard Deviation 25.00	70.83 units on a scale Standard Deviation 21.61
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Mental Health	73.57 units on a scale Standard Deviation 16.26	81.25 units on a scale Standard Deviation 8.54	87.00 units on a scale Standard Deviation 14.38
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: General Health	1.57 units on a scale Standard Deviation 12.22	6.25 units on a scale Standard Deviation 4.79	-3.90 units on a scale Standard Deviation 13.10
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Physical Function	14.29 units on a scale Standard Deviation 27.60	25.00 units on a scale Standard Deviation 10.80	5.00 units on a scale Standard Deviation 32.32
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Role Physical	8.04 units on a scale Standard Deviation 25.95	31.25 units on a scale Standard Deviation 24.47	17.50 units on a scale Standard Deviation 14.37
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Bodily Pain	8.00 units on a scale Standard Deviation 35.23	34.75 units on a scale Standard Deviation 14.03	13.60 units on a scale Standard Deviation 19.39
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Vitality	7.14 units on a scale Standard Deviation 14.17	17.19 units on a scale Standard Deviation 11.83	3.75 units on a scale Standard Deviation 5.27
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Social Function	3.57 units on a scale Standard Deviation 11.89	21.88 units on a scale Standard Deviation 25.77	0.00 units on a scale Standard Deviation 15.59
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Role Emotional	-2.38 units on a scale Standard Deviation 30.32	6.25 units on a scale Standard Deviation 29.95	5.00 units on a scale Standard Deviation 23.31
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Mental Health	1.43 units on a scale Standard Deviation 14.06	8.75 units on a scale Standard Deviation 8.54	-5.50 units on a scale Standard Deviation 8.32

OTHER_PRE_SPECIFIED outcome

Timeframe: A4091026: Baseline, A4091040: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method.

SF-36v2 is a self-administered questionnaire evaluating 8 aspects/domains of functional health and wellbeing: physical function, role physical, bodily pain, vitality, general health, social function, role emotional and mental health. Total score for each aspect were scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score -mean score for general 1990 United States \[US\] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score \[better functioning\])/lower (in case of negative z-score \[worse functioning\]) participant's value was relative to the mean of the reference population. Change from baseline \>0 indicates an improvement.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg + Standard of Care n=7 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 Participants Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 Participants Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24 Baseline: Mental Component Score	0.17 z-score Standard Deviation 0.92	0.55 z-score Standard Deviation 0.61	0.83 z-score Standard Deviation 1.17
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24 Baseline: Physical Component Score	-0.95 z-score Standard Deviation 1.08	-1.33 z-score Standard Deviation 1.04	-1.88 z-score Standard Deviation 0.63
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24 Change at Week 24: Mental Component Score	-0.09 z-score Standard Deviation 0.90	0.28 z-score Standard Deviation 0.93	-0.19 z-score Standard Deviation 0.50
Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24 Change at Week 24: Physical Component Score	0.50 z-score Standard Deviation 1.03	1.27 z-score Standard Deviation 0.39	0.50 z-score Standard Deviation 0.95

Adverse Events

Tanezumab 5 mg + Standard of Care

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Tanezumab 10 mg + Standard of Care

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo + Standard of Care

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tanezumab 5 mg + Standard of Care n=7 participants at risk Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs \[NSAIDs\], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities.	Tanezumab 10 mg + Standard of Care n=4 participants at risk Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.	Placebo + Standard of Care n=10 participants at risk Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities.
Musculoskeletal and connective tissue disorders Osteoarthritis	14.3% 1/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/7 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	25.0% 1/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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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