Trial Outcomes & Findings for Tanezumab and Nerve Function In Arthritis Patients (NCT NCT00863772)

NCT ID: NCT00863772

Last Updated: 2021-02-04

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: 220 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2021-02-04

Participant Flow

Participants who discontinued due to lack of efficacy or completed the treatment in this study, were eligible to enroll in the safety extension study A4091040 (NCT00960804).

Participant milestones

Measure	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Overall Study STARTED	74	74	72
Overall Study Treated	73	74	72
Overall Study COMPLETED	6	9	11
Overall Study NOT COMPLETED	68	65	61

Reasons for withdrawal

Measure	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Overall Study Adverse Event	1	4	0
Overall Study Lack of Efficacy	4	2	4
Overall Study Lost to Follow-up	5	1	1
Overall Study Protocol Violation	2	0	2
Overall Study Withdrawal by Subject	4	7	5
Overall Study Study terminated by sponsor	44	45	36
Overall Study Entered extension study	6	4	9
Overall Study Other	1	2	4
Overall Study Randomized but not Treated	1	0	0

Baseline Characteristics

Tanezumab and Nerve Function In Arthritis Patients

Baseline characteristics by cohort

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Total n=219 Participants Total of all reporting groups
Age, Customized 18 to 44 years	3 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	18 Participants n=4 Participants
Age, Customized 45 to 64 years	63 Participants n=5 Participants	53 Participants n=7 Participants	50 Participants n=5 Participants	166 Participants n=4 Participants
Age, Customized Greater than or equal to (>=) 65 years	7 Participants n=5 Participants	17 Participants n=7 Participants	11 Participants n=5 Participants	35 Participants n=4 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	47 Participants n=7 Participants	39 Participants n=5 Participants	130 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	27 Participants n=7 Participants	33 Participants n=5 Participants	89 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using last observation carried forward (LOCF) method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

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.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Intent to Treat (ITT) Analysis Set Baseline	0.61 normal deviate score Standard Deviation 2.96	1.52 normal deviate score Standard Deviation 2.50	0.51 normal deviate score Standard Deviation 2.71
Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Intent to Treat (ITT) Analysis Set Change at Week 24	0.18 normal deviate score Standard Deviation 2.38	-0.18 normal deviate score Standard Deviation 1.73	-0.15 normal deviate score Standard Deviation 2.18

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

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.

Outcome measures

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Per Protocol Analysis Set (PPAS) Baseline	0.45 normal deviate score Standard Deviation 2.83	1.46 normal deviate score Standard Deviation 2.46	0.57 normal deviate score Standard Deviation 2.69
Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Per Protocol Analysis Set (PPAS) Change at Week 24	0.13 normal deviate score Standard Deviation 2.41	-0.19 normal deviate score Standard Deviation 1.74	-0.11 normal deviate score Standard Deviation 2.17

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

NIS-LL: assess muscle weakness, reflexes, sensation; scored separately for left and 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

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Neuropathy Impairment Score - Lower Limbs [NIS (LL)] at Week 24 Change at Week 24	0.21 units on a scale Standard Deviation 0.92	0.03 units on a scale Standard Deviation 0.95	0.06 units on a scale Standard Deviation 0.38
Change From Baseline in Neuropathy Impairment Score - Lower Limbs [NIS (LL)] at Week 24 Baseline	0.00 units on a scale Standard Deviation 0.00	0.08 units on a scale Standard Deviation 0.70	0.00 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0 to 244, higher score = greater impairment.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24 Baseline	0.00 units on a scale Standard Deviation 0.00	0.09 units on a scale Standard Deviation 0.81	0.00 units on a scale Standard Deviation 0.00
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24 Change at Week 24	0.26 units on a scale Standard Deviation 1.33	0.07 units on a scale Standard Deviation 1.35	0.06 units on a scale Standard Deviation 0.38

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

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. A change from Baseline > 0 indicated some symptoms of peripheral neuropathy.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From 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
Change From Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24 Change at Week 24	0.31 units on a scale Standard Deviation 1.03	0.13 units on a scale Standard Deviation 0.57	0.11 units on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Peroneal motor nerve compound muscle action potential amplitude (in millivolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (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 indicated worse response and >0 indicated better response than the 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. Mean of the two NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: ITT Analysis Set Baseline	-0.37 normal deviate score Standard Deviation 0.94	-0.55 normal deviate score Standard Deviation 0.85	-0.09 normal deviate score Standard Deviation 0.92
Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: ITT Analysis Set Change at Week 24	-0.12 normal deviate score Standard Deviation 0.65	-0.11 normal deviate score Standard Deviation 0.50	-0.05 normal deviate score Standard Deviation 0.59

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Peroneal motor nerve compound muscle action potential amplitude (in millivolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (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 indicated worse response and >0 indicated better response than the 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. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: PPAS Baseline	-0.35 normal deviate score Standard Deviation 0.94	-0.55 normal deviate score Standard Deviation 0.86	-0.07 normal deviate score Standard Deviation 0.91
Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: PPAS Change at Week 24	-0.10 normal deviate score Standard Deviation 0.66	-0.10 normal deviate score Standard Deviation 0.50	-0.06 normal deviate score Standard Deviation 0.59

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Peroneal motor nerve conduction velocity (in meters/second) was measured using electromyography of the left lower limb. Values were scored as percentiles (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 indicated worse response and >0 indicated better response than the 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. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Peroneal Motor Nerve Conduction Velocity (MNCV) Score at Week 24: ITT Analysis Set Baseline	0.75 normal deviate score Standard Deviation 1.50	0.22 normal deviate score Standard Deviation 1.28	0.26 normal deviate score Standard Deviation 1.52
Change From Baseline in Peroneal Motor Nerve Conduction Velocity (MNCV) Score at Week 24: ITT Analysis Set Change at Week 24	-0.01 normal deviate score Standard Deviation 0.91	0.12 normal deviate score Standard Deviation 1.03	-0.04 normal deviate score Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Peroneal motor nerve conduction velocity (in meters/second) was measured using electromyography of the left lower limb. Values were scored as percentiles (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 indicated worse response and >0 indicated better response than the 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. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Peroneal Motor Nerve Conduction Velocity (MNCV) Score at Week 24: PPAS Baseline	0.76 normal deviate score Standard Deviation 1.52	0.24 normal deviate score Standard Deviation 1.28	0.21 normal deviate score Standard Deviation 1.48
Change From Baseline in Peroneal Motor Nerve Conduction Velocity (MNCV) Score at Week 24: PPAS Change at Week 24	-0.01 normal deviate score Standard Deviation 0.91	0.11 normal deviate score Standard Deviation 1.04	-0.04 normal deviate score Standard Deviation 0.68

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Peroneal motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (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 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. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Peroneal Motor Nerve Distal Latency (MNDL) Score at Week 24: ITT Analysis Set Baseline	-0.19 normal deviate score Standard Deviation 1.27	0.01 normal deviate score Standard Deviation 1.16	-0.35 normal deviate score Standard Deviation 1.07
Change From Baseline in Peroneal Motor Nerve Distal Latency (MNDL) Score at Week 24: ITT Analysis Set Change at Week 24	-0.03 normal deviate score Standard Deviation 0.99	-0.13 normal deviate score Standard Deviation 0.56	-0.08 normal deviate score Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Peroneal motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (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 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. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Peroneal Motor Nerve Distal Latency (MNDL) Score at Week 24: PPAS Baseline	-0.24 normal deviate score Standard Deviation 1.25	-0.01 normal deviate score Standard Deviation 1.15	-0.32 normal deviate score Standard Deviation 1.05
Change From Baseline in Peroneal Motor Nerve Distal Latency (MNDL) Score at Week 24: PPAS Change at Week 24	-0.03 normal deviate score Standard Deviation 1.01	-0.14 normal deviate score Standard Deviation 0.57	-0.07 normal deviate score Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' participants who were evaluable at specific time points for each arm, respectively.

Tibial motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (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 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. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Tibial Motor Nerve Distal Latency (MNDL) Score at Week 24: ITT Analysis Set Baseline	0.73 normal deviate score Standard Deviation 1.25	0.90 normal deviate score Standard Deviation 1.18	0.83 normal deviate score Standard Deviation 1.09
Change From Baseline in Tibial Motor Nerve Distal Latency (MNDL) Score at Week 24: ITT Analysis Set Change at Week 24	0.20 normal deviate score Standard Deviation 1.08	-0.16 normal deviate score Standard Deviation 0.81	-0.08 normal deviate score Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here, 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Tibial motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (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 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. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Tibial Motor Nerve Distal Latency (MNDL) Score at Week 24: PPAS Baseline	0.69 normal deviate score Standard Deviation 1.24	0.90 normal deviate score Standard Deviation 1.19	0.82 normal deviate score Standard Deviation 1.09
Change From Baseline in Tibial Motor Nerve Distal Latency (MNDL) Score at Week 24: PPAS Change at Week 24	0.20 normal deviate score Standard Deviation 1.10	-0.17 normal deviate score Standard Deviation 0.80	-0.09 normal deviate score Standard Deviation 0.92

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Sural sensory nerve action potential amplitude (in microvolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (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. A score <0 indicated worse response and >0 indicated better response than the normal matched population. A change <0 indicated worsening and >0 indicated improvement compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Sural Sensory Nerve Action Potential Amplitude (SNAP) Score at Week 24: ITT Analysis Set Baseline	-0.20 normal deviate score Standard Deviation 1.12	-0.06 normal deviate score Standard Deviation 1.00	-0.22 normal deviate score Standard Deviation 1.07
Change From Baseline in Sural Sensory Nerve Action Potential Amplitude (SNAP) Score at Week 24: ITT Analysis Set Change at Week 24	-0.03 normal deviate score Standard Deviation 0.97	-0.12 normal deviate score Standard Deviation 0.71	0.01 normal deviate score Standard Deviation 0.86

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here, 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Sural sensory nerve action potential amplitude (in microvolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (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. A score <0 indicated worse response and >0 indicated better response than the normal matched population. A change <0 indicated worsening and >0 indicated improvement compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Sural Sensory Nerve Action Potential Amplitude (SNAP) Score at Week 24: PPAS Baseline	-0.17 normal deviate score Standard Deviation 1.09	-0.05 normal deviate score Standard Deviation 1.00	-0.25 normal deviate score Standard Deviation 1.05
Change From Baseline in Sural Sensory Nerve Action Potential Amplitude (SNAP) Score at Week 24: PPAS Change at Week 24	0.01 normal deviate score Standard Deviation 0.93	-0.12 normal deviate score Standard Deviation 0.72	0.03 normal deviate score Standard Deviation 0.85

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

HRdb test was used to evaluate the effect of treatment on autonomic function. Participants 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 a 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 of HRdb were collected twice and highest nd score was selected at each NV. Mean of the 2 selected NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Heart Rate Deep Breathing [HRdb] at Week 24: ITT Analysis Set Baseline	-0.25 normal deviate score Standard Deviation 0.76	-0.23 normal deviate score Standard Deviation 0.79	0.01 normal deviate score Standard Deviation 1.05
Change From Baseline in Heart Rate Deep Breathing [HRdb] at Week 24: ITT Analysis Set Change at Week 24	0.06 normal deviate score Standard Deviation 0.57	-0.01 normal deviate score Standard Deviation 0.66	0.02 normal deviate score Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

HRdb test was used to evaluate the effect of treatment on autonomic function. Participants 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 a 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 of HRdb were collected twice and highest nd score was selected at each NV. Mean of the 2 selected NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Heart Rate Deep Breathing [HRdb] at Week 24: PPAS Baseline	-0.23 normal deviate score Standard Deviation 0.76	-0.22 normal deviate score Standard Deviation 0.79	0.04 normal deviate score Standard Deviation 1.04
Change From Baseline in Heart Rate Deep Breathing [HRdb] at Week 24: PPAS Change at Week 24	0.05 normal deviate score Standard Deviation 0.57	-0.02 normal deviate score Standard Deviation 0.66	0.02 normal deviate score Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

5NC (nd) score included 5 NCS attributes: peroneal MNDL, CMAP, MNCV, tibial MNDL and sural SNAP. Values of attributes scored as percentiles (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. 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. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in 5 Nerve Conduction Test - Normal Deviate [5NC (nd)] at Week 24: ITT Analysis Set Change at Week 24	0.34 normal deviate score Standard Deviation 2.04	-0.18 normal deviate score Standard Deviation 1.60	-0.09 normal deviate score Standard Deviation 2.03
Change From Baseline in 5 Nerve Conduction Test - Normal Deviate [5NC (nd)] at Week 24: ITT Analysis Set Baseline	0.36 normal deviate score Standard Deviation 2.86	1.30 normal deviate score Standard Deviation 2.18	0.53 normal deviate score Standard Deviation 2.62

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

5NC (nd) score included 5 NCS attributes: peroneal MNDL, CMAP, MNCV, tibial MNDL and sural SNAP. Values of attributes scored as percentiles (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. 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.2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.

Outcome measures

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in 5 Nerve Conduction Test - Normal Deviate (5NC [nd]) at Week 24: PPAS Baseline	0.22 normal deviate score Standard Deviation 2.76	1.25 normal deviate score Standard Deviation 2.15	0.60 normal deviate score Standard Deviation 2.56
Change From Baseline in 5 Nerve Conduction Test - Normal Deviate (5NC [nd]) at Week 24: PPAS Change at Week 24	0.28 normal deviate score Standard Deviation 2.05	-0.20 normal deviate score Standard Deviation 1.60	-0.09 normal deviate score Standard Deviation 2.05

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values imputed using LOCF. Here 'overall number of participants analyzed' signifies participants evaluable for this measure and 'number analyzed' signifies participants evaluable at specific time points for each arm, respectively.

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

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=71 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Protein Gene Product (PGP) 9.5-Positive Intraepidermal Epidermal Nerve Fiber (IENF) Density at Week 24 Baseline	11.61 nerve fiber count/millimeter Standard Deviation 6.33	11.31 nerve fiber count/millimeter Standard Deviation 5.01	12.43 nerve fiber count/millimeter Standard Deviation 6.48
Change From Baseline in Protein Gene Product (PGP) 9.5-Positive Intraepidermal Epidermal Nerve Fiber (IENF) Density at Week 24 Change at Week 24	0.31 nerve fiber count/millimeter Standard Deviation 4.17	-0.91 nerve fiber count/millimeter Standard Deviation 3.86	-0.52 nerve fiber count/millimeter Standard Deviation 4.15

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

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) in 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

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 8, 16, and 24 Baseline	5.99 units on a scale Standard Deviation 1.49	6.45 units on a scale Standard Deviation 1.34	6.54 units on a scale Standard Deviation 1.55
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 8, 16, and 24 Change at Week 8	-2.09 units on a scale Standard Deviation 2.44	-2.87 units on a scale Standard Deviation 2.82	-1.12 units on a scale Standard Deviation 1.78
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 8, 16, and 24 Change at Week 16	-2.12 units on a scale Standard Deviation 2.22	-2.56 units on a scale Standard Deviation 2.75	-1.35 units on a scale Standard Deviation 1.80
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 8, 16, and 24 Change at Week 24	-2.06 units on a scale Standard Deviation 2.38	-2.46 units on a scale Standard Deviation 2.68	-1.39 units on a scale Standard Deviation 1.85

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 8, 16, and 24 Baseline	6.04 units on a scale Standard Deviation 1.55	6.19 units on a scale Standard Deviation 1.62	6.52 units on a scale Standard Deviation 1.70
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 8, 16, and 24 Change at Week 8	-1.86 units on a scale Standard Deviation 2.44	-2.90 units on a scale Standard Deviation 2.74	-1.03 units on a scale Standard Deviation 1.79
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 8, 16, and 24 Change at Week 16	-1.99 units on a scale Standard Deviation 2.37	-2.61 units on a scale Standard Deviation 2.68	-1.15 units on a scale Standard Deviation 1.85
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 8, 16, and 24 Change at Week 24	-1.97 units on a scale Standard Deviation 2.50	-2.47 units on a scale Standard Deviation 2.62	-1.19 units on a scale Standard Deviation 1.82

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Participants answered: 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 scale where 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 activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 8, 16, and 24 Change at Week 16	-0.78 units on a scale Standard Deviation 0.98	-0.82 units on a scale Standard Deviation 1.06	-0.56 units on a scale Standard Deviation 0.82
Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 8, 16, and 24 Baseline	3.29 units on a scale Standard Deviation 0.51	3.28 units on a scale Standard Deviation 0.45	3.36 units on a scale Standard Deviation 0.56
Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 8, 16, and 24 Change at Week 8	-0.70 units on a scale Standard Deviation 0.95	-0.88 units on a scale Standard Deviation 1.08	-0.46 units on a scale Standard Deviation 0.80
Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 8, 16, and 24 Change at Week 24	-0.75 units on a scale Standard Deviation 1.00	-0.74 units on a scale Standard Deviation 1.01	-0.56 units on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

OMERACT-OARSI response: >=50 percent (%) improvement from baseline and absolute change from baseline of >=2 units in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit 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

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 8	49.3 percentage of participants	64.9 percentage of participants	37.5 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 16	52.1 percentage of participants	62.2 percentage of participants	40.3 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Week 24	52.1 percentage of participants	59.5 percentage of participants	38.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). 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) in the past 48 hours. It is calculated as the mean of the scores from 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

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=30% Reduction	46.6 percentage of participants	56.8 percentage of participants	30.6 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=70% Reduction	26.0 percentage of participants	32.4 percentage of participants	5.6 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=90% Reduction	15.1 percentage of participants	18.9 percentage of participants	2.8 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=30% Reduction	47.9 percentage of participants	54.1 percentage of participants	36.1 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=90% Reduction	11.0 percentage of participants	18.9 percentage of participants	2.8 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 24: >=30% Reduction	46.6 percentage of participants	52.7 percentage of participants	36.1 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 8: >=50% Reduction	37.0 percentage of participants	44.6 percentage of participants	15.3 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=50% Reduction	39.7 percentage of participants	39.2 percentage of participants	15.3 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 16: >=70% Reduction	24.7 percentage of participants	27.0 percentage of participants	9.7 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 24: >=50% Reduction	35.6 percentage of participants	37.8 percentage of participants	20.8 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 24: >=70% Reduction	26.0 percentage of participants	25.7 percentage of participants	9.7 percentage of participants
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Week 24: >=90% Reduction	13.7 percentage of participants	17.6 percentage of participants	4.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Participants answered: 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 scale where 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 activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Percentage of Participants With Improvement of At Least 2 Points From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Week 16	21.9 percentage of participants	29.7 percentage of participants	12.5 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Week 8	19.2 percentage of participants	31.1 percentage of participants	8.3 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Week 24	21.9 percentage of participants	27.0 percentage of participants	9.7 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). 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) in 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. Participants with specified reduction (as percent) from baseline at Week 16 are reported.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >0%	55 Participants	50 Participants	51 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >=10%	45 Participants	48 Participants	39 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >=20%	39 Participants	46 Participants	31 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >=50%	29 Participants	29 Participants	11 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >=90%	8 Participants	14 Participants	2 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >=30%	35 Participants	40 Participants	26 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >=40%	34 Participants	31 Participants	21 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >=60%	26 Participants	24 Participants	9 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >=70%	18 Participants	20 Participants	7 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score >=80%	13 Participants	15 Participants	4 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score 100%	4 Participants	9 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Participants assessed daily average index joint pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Higher score indicated greater pain.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Baseline	6.04 units on a scale Standard Deviation 1.73	6.33 units on a scale Standard Deviation 1.67	6.45 units on a scale Standard Deviation 1.88
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 12	-2.37 units on a scale Standard Deviation 2.28	-2.72 units on a scale Standard Deviation 2.87	-1.32 units on a scale Standard Deviation 2.07
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 19	-2.26 units on a scale Standard Deviation 2.18	-2.73 units on a scale Standard Deviation 2.90	-1.17 units on a scale Standard Deviation 1.95
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 20	-2.32 units on a scale Standard Deviation 2.26	-2.71 units on a scale Standard Deviation 2.89	-1.20 units on a scale Standard Deviation 1.88
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 21	-2.32 units on a scale Standard Deviation 2.24	-2.74 units on a scale Standard Deviation 2.91	-1.24 units on a scale Standard Deviation 1.93
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 22	-2.30 units on a scale Standard Deviation 2.18	-2.71 units on a scale Standard Deviation 2.89	-1.29 units on a scale Standard Deviation 2.00
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 1	-1.62 units on a scale Standard Deviation 1.80	-2.04 units on a scale Standard Deviation 1.97	-0.75 units on a scale Standard Deviation 1.36
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 2	-1.88 units on a scale Standard Deviation 2.08	-2.00 units on a scale Standard Deviation 2.35	-0.94 units on a scale Standard Deviation 1.81
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 3	-1.80 units on a scale Standard Deviation 2.26	-2.13 units on a scale Standard Deviation 2.67	-0.99 units on a scale Standard Deviation 1.93
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 4	-2.32 units on a scale Standard Deviation 2.26	-2.92 units on a scale Standard Deviation 2.79	-1.05 units on a scale Standard Deviation 1.86
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 5	-2.46 units on a scale Standard Deviation 2.27	-2.98 units on a scale Standard Deviation 2.86	-1.17 units on a scale Standard Deviation 1.87
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 6	-2.48 units on a scale Standard Deviation 2.31	-3.00 units on a scale Standard Deviation 2.88	-1.21 units on a scale Standard Deviation 1.97
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 7	-2.48 units on a scale Standard Deviation 2.36	-2.97 units on a scale Standard Deviation 3.04	-1.21 units on a scale Standard Deviation 1.93
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 8	-2.46 units on a scale Standard Deviation 2.37	-2.82 units on a scale Standard Deviation 2.97	-1.10 units on a scale Standard Deviation 1.81
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 9	-2.44 units on a scale Standard Deviation 2.41	-2.87 units on a scale Standard Deviation 2.93	-1.12 units on a scale Standard Deviation 1.90
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 10	-2.42 units on a scale Standard Deviation 2.36	-2.77 units on a scale Standard Deviation 2.85	-1.32 units on a scale Standard Deviation 2.14
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 11	-2.33 units on a scale Standard Deviation 2.20	-2.62 units on a scale Standard Deviation 2.88	-1.36 units on a scale Standard Deviation 2.12
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 13	-2.26 units on a scale Standard Deviation 2.26	-2.81 units on a scale Standard Deviation 2.94	-1.26 units on a scale Standard Deviation 2.04
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 14	-2.35 units on a scale Standard Deviation 2.27	-2.71 units on a scale Standard Deviation 2.94	-1.23 units on a scale Standard Deviation 1.88
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 15	-2.30 units on a scale Standard Deviation 2.23	-2.74 units on a scale Standard Deviation 2.91	-1.19 units on a scale Standard Deviation 1.89
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 16	-2.27 units on a scale Standard Deviation 2.20	-2.62 units on a scale Standard Deviation 2.88	-1.15 units on a scale Standard Deviation 1.96
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 17	-2.33 units on a scale Standard Deviation 2.16	-2.68 units on a scale Standard Deviation 2.96	-1.25 units on a scale Standard Deviation 2.07
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 18	-2.40 units on a scale Standard Deviation 2.33	-2.71 units on a scale Standard Deviation 2.95	-1.20 units on a scale Standard Deviation 2.04
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 23	-2.30 units on a scale Standard Deviation 2.25	-2.66 units on a scale Standard Deviation 2.90	-1.28 units on a scale Standard Deviation 1.97
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 Change at Week 24	-2.28 units on a scale Standard Deviation 2.30	-2.64 units on a scale Standard Deviation 2.90	-1.20 units on a scale Standard Deviation 1.87

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10, with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 8, 16, and 24 Change at Week 8	-2.14 units on a scale Standard Deviation 2.64	-3.18 units on a scale Standard Deviation 2.95	-1.08 units on a scale Standard Deviation 1.92
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 8, 16, and 24 Change at Week 16	-2.36 units on a scale Standard Deviation 2.53	-2.84 units on a scale Standard Deviation 2.90	-1.22 units on a scale Standard Deviation 1.91
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 8, 16, and 24 Change at Week 24	-2.37 units on a scale Standard Deviation 2.66	-2.70 units on a scale Standard Deviation 2.86	-1.33 units on a scale Standard Deviation 2.02
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 8, 16, and 24 Baseline	6.38 units on a scale Standard Deviation 1.80	6.74 units on a scale Standard Deviation 1.62	6.72 units on a scale Standard Deviation 1.82

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). 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

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 8, 16, and 24 Change at Week 8	-2.03 units on a scale Standard Deviation 2.41	-2.98 units on a scale Standard Deviation 2.78	-1.08 units on a scale Standard Deviation 1.73
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 8, 16, and 24 Change at Week 16	-2.16 units on a scale Standard Deviation 2.29	-2.67 units on a scale Standard Deviation 2.71	-1.24 units on a scale Standard Deviation 1.75
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 8, 16, and 24 Baseline	6.14 units on a scale Standard Deviation 1.51	6.46 units on a scale Standard Deviation 1.40	6.59 units on a scale Standard Deviation 1.62
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 8, 16, and 24 Change at Week 24	-2.13 units on a scale Standard Deviation 2.44	-2.54 units on a scale Standard Deviation 2.66	-1.30 units on a scale Standard Deviation 1.80

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Participants answered: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain. Change from baseline <0 indicated an improvement.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 8, 16, and 24 Baseline	5.88 units on a scale Standard Deviation 1.55	6.20 units on a scale Standard Deviation 1.52	6.47 units on a scale Standard Deviation 1.64
Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 8, 16, and 24 Change at Week 8	-2.01 units on a scale Standard Deviation 2.51	-2.74 units on a scale Standard Deviation 2.94	-1.21 units on a scale Standard Deviation 1.96
Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 8, 16, and 24 Change at Week 16	-2.04 units on a scale Standard Deviation 2.26	-2.53 units on a scale Standard Deviation 2.84	-1.44 units on a scale Standard Deviation 1.98
Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 8, 16, and 24 Change at Week 24	-1.97 units on a scale Standard Deviation 2.41	-2.35 units on a scale Standard Deviation 2.75	-1.38 units on a scale Standard Deviation 1.95

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Participants answered: How much pain have you had when going up or down stairs?. Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain. Change from baseline <0 indicates an improvement.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 8, 16, and 24 Baseline	7.16 units on a scale Standard Deviation 1.72	7.49 units on a scale Standard Deviation 1.30	7.61 units on a scale Standard Deviation 1.60
Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 8, 16, and 24 Change at Week 8	-2.30 units on a scale Standard Deviation 2.71	-3.04 units on a scale Standard Deviation 2.98	-1.17 units on a scale Standard Deviation 2.05
Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 8, 16, and 24 Change at Week 16	-2.32 units on a scale Standard Deviation 2.49	-2.74 units on a scale Standard Deviation 2.94	-1.21 units on a scale Standard Deviation 2.24
Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 8, 16, and 24 Change at Week 24	-2.22 units on a scale Standard Deviation 2.67	-2.64 units on a scale Standard Deviation 2.87	-1.18 units on a scale Standard Deviation 2.16

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). 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. The total score for each domain is scaled 0-100 (100 = highest level of functioning). Change from baseline >0 indicates an improvement.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Bodily Pain	39.44 units on a scale Standard Deviation 15.53	36.36 units on a scale Standard Deviation 14.78	37.97 units on a scale Standard Deviation 16.49
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Social Function	72.09 units on a scale Standard Deviation 22.68	75.00 units on a scale Standard Deviation 22.38	73.96 units on a scale Standard Deviation 25.76
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Role Emotional	75.23 units on a scale Standard Deviation 26.89	74.44 units on a scale Standard Deviation 27.97	71.64 units on a scale Standard Deviation 27.71
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Mental Health	76.78 units on a scale Standard Deviation 16.92	77.70 units on a scale Standard Deviation 16.90	76.88 units on a scale Standard Deviation 18.30
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: General Health	0.44 units on a scale Standard Deviation 8.57	0.72 units on a scale Standard Deviation 5.56	-0.28 units on a scale Standard Deviation 7.84
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Physical Function	3.72 units on a scale Standard Deviation 12.34	4.66 units on a scale Standard Deviation 12.34	3.13 units on a scale Standard Deviation 16.43
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Bodily Pain	3.25 units on a scale Standard Deviation 13.98	6.30 units on a scale Standard Deviation 16.98	4.07 units on a scale Standard Deviation 10.88
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Social Function	0.51 units on a scale Standard Deviation 8.70	1.86 units on a scale Standard Deviation 15.98	0.17 units on a scale Standard Deviation 10.38
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Role Emotional	-2.05 units on a scale Standard Deviation 13.59	2.14 units on a scale Standard Deviation 16.09	3.70 units on a scale Standard Deviation 15.57
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Mental Health	0.07 units on a scale Standard Deviation 7.61	0.95 units on a scale Standard Deviation 10.19	-0.42 units on a scale Standard Deviation 5.98
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: General Health	72.22 units on a scale Standard Deviation 14.75	72.36 units on a scale Standard Deviation 16.39	70.85 units on a scale Standard Deviation 20.25
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Physical Function	38.00 units on a scale Standard Deviation 19.58	38.58 units on a scale Standard Deviation 18.50	40.28 units on a scale Standard Deviation 23.19
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Role Physical	53.08 units on a scale Standard Deviation 24.81	49.75 units on a scale Standard Deviation 26.26	49.57 units on a scale Standard Deviation 27.36
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Baseline: Vitality	55.74 units on a scale Standard Deviation 19.09	56.53 units on a scale Standard Deviation 19.50	57.90 units on a scale Standard Deviation 22.15
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Role Physical	1.71 units on a scale Standard Deviation 11.47	5.74 units on a scale Standard Deviation 15.92	5.82 units on a scale Standard Deviation 12.60
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 Change at Week 24: Vitality	1.20 units on a scale Standard Deviation 8.82	2.03 units on a scale Standard Deviation 9.82	0.52 units on a scale Standard Deviation 6.00

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). 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

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24 Baseline: Mental Component Score	0.34 Z-score Standard Deviation 1.09	0.42 Z-score Standard Deviation 1.12	0.32 Z-score Standard Deviation 1.18
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24 Baseline: Physical Component Score	-1.54 Z-score Standard Deviation 0.74	-1.62 Z-score Standard Deviation 0.74	-1.55 Z-score Standard Deviation 0.82
Change From 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	-0.08 Z-score Standard Deviation 0.48	0.02 Z-score Standard Deviation 0.57	-0.00 Z-score Standard Deviation 0.44
Change From 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	0.16 Z-score Standard Deviation 0.52	0.23 Z-score Standard Deviation 0.55	0.16 Z-score Standard Deviation 0.49

SECONDARY outcome

Timeframe: Week 8, 16, 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

In case of inadequate pain relief for osteoarthritis during the treatment period, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.

Outcome measures

Measure	Tanezumab 5 mg n=70 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Number of Participants With Rescue Medication Usage Week 8	25 Participants	38 Participants	40 Participants
Number of Participants With Rescue Medication Usage Week 16	23 Participants	28 Participants	41 Participants
Number of Participants With Rescue Medication Usage Week 24	23 Participants	23 Participants	36 Participants

SECONDARY outcome

Timeframe: Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

In case of inadequate pain relief for osteoarthritis during the treatment period, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Result reported is number of days of rescue medication use in each week, and ranges from 0 to 7.

Outcome measures

Measure	Tanezumab 5 mg n=70 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Number of Days With Rescue Medication Usage Week 8	1.0 days per week Standard Deviation 1.79	1.2 days per week Standard Deviation 1.64	1.4 days per week Standard Deviation 1.80
Number of Days With Rescue Medication Usage Week 16	0.9 days per week Standard Deviation 1.69	0.8 days per week Standard Deviation 1.41	1.3 days per week Standard Deviation 1.80
Number of Days With Rescue Medication Usage Week 24	1.0 days per week Standard Deviation 1.85	0.7 days per week Standard Deviation 1.40	1.4 days per week Standard Deviation 1.98

SECONDARY outcome

Timeframe: Weeks 8, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

In case of inadequate pain relief for osteoarthritis during the treatment period, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Results reported is total dose of acetaminophen (in mg) for each week.

Outcome measures

Measure	Tanezumab 5 mg n=70 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Amount of Rescue Medication Used Week 8	1192.9 mg per week Standard Deviation 2317.7	1422.5 mg per week Standard Deviation 2391.4	2402.8 mg per week Standard Deviation 3899.8
Amount of Rescue Medication Used Week 16	1128.6 mg per week Standard Deviation 2270.9	1028.2 mg per week Standard Deviation 2253.4	2222.2 mg per week Standard Deviation 3608.4
Amount of Rescue Medication Used Week 24	1228.6 mg per week Standard Deviation 2422.2	908.5 mg per week Standard Deviation 2252.5	2194.4 mg per week Standard Deviation 3598.3

SECONDARY outcome

Timeframe: pre-dose on Day 1 (Baseline), Week 8, 16, 24, 32

Population: ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure at any time point and 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively. This outcome was not planned to be analyzed for the 'placebo" arm.

Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semiquantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.

Outcome measures

Measure	Tanezumab 5 mg n=71 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=70 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Number of Participants With Anti-Drug Antibody (ADA) Baseline	1 Participants	2 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Week 8	1 Participants	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Week 16	0 Participants	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Week 24	2 Participants	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Week 32	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: pre-dose on Day 1 (Baseline), Weeks 8, 16, 24, and 32

Population: ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure at any time point and 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively. This outcome was not planned to be analyzed for the 'placebo" arm.

Plasma trough concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	Tanezumab 5 mg n=65 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=65 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Plasma Trough Concentration of Tanezumab Week 16	188.3 nanogram per milliliter (ng/mL) Standard Deviation 131.70	554.9 nanogram per milliliter (ng/mL) Standard Deviation 280.30	—
Plasma Trough Concentration of Tanezumab Baseline	84.38 nanogram per milliliter (ng/mL) Standard Deviation 482.59	35.68 nanogram per milliliter (ng/mL) Standard Deviation 176.41	—
Plasma Trough Concentration of Tanezumab Week 8	144.2 nanogram per milliliter (ng/mL) Standard Deviation 95.415	342.3 nanogram per milliliter (ng/mL) Standard Deviation 183.27	—
Plasma Trough Concentration of Tanezumab Week 24	63.94 nanogram per milliliter (ng/mL) Standard Deviation 90.513	279.5 nanogram per milliliter (ng/mL) Standard Deviation 422.57	—
Plasma Trough Concentration of Tanezumab Week 32	34.15 nanogram per milliliter (ng/mL) Standard Deviation 53.407	95.90 nanogram per milliliter (ng/mL) Standard Deviation 53.859	—

SECONDARY outcome

Timeframe: Baseline through 112 days after last Intravenous dose of Investigational product to last participant treated with study medication on study (up to Week 32 after last IV dose of investigational product to last participant treated)

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious AEs and non-serious AEs.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	41 participants	48 participants	39 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 participants	3 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).

Number of participants are reported based on the maximum number of intravenous (IV) doses of either tanezumab or placebo received.

Outcome measures

Measure	Tanezumab 5 mg n=73 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Number of Participants With Intravenous Doses of Study Medication 1 dose	41 Participants	40 Participants	33 Participants
Number of Participants With Intravenous Doses of Study Medication 2 doses	16 Participants	16 Participants	16 Participants
Number of Participants With Intravenous Doses of Study Medication 3 doses	16 Participants	18 Participants	23 Participants

Adverse Events

Tanezumab 5 mg

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Tanezumab 10 mg

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tanezumab 5 mg n=73 participants at risk Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 participants at risk Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 participants at risk Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	1.4% 1/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	1.4% 1/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	1.4% 1/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Syncope	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	1.4% 1/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	1.4% 1/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.

Other adverse events

Measure	Tanezumab 5 mg n=73 participants at risk Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=74 participants at risk Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo n=72 participants at risk Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Musculoskeletal and connective tissue disorders Arthralgia	16.4% 12/73 The same event may appear as both an AE and a SAE. 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.	20.3% 15/74 The same event may appear as both an AE and a SAE. 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.	8.3% 6/72 The same event may appear as both an AE and a SAE. 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.
Gastrointestinal disorders Diarrhoea	1.4% 1/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	1.4% 1/72 The same event may appear as both an AE and a SAE. 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.
Gastrointestinal disorders Nausea	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	1.4% 1/72 The same event may appear as both an AE and a SAE. 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.
Gastrointestinal disorders Vomiting	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
General disorders Oedema peripheral	4.1% 3/73 The same event may appear as both an AE and a SAE. 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.	8.1% 6/74 The same event may appear as both an AE and a SAE. 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.	1.4% 1/72 The same event may appear as both an AE and a SAE. 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.
Infections and infestations Cellulitis	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	1.4% 1/72 The same event may appear as both an AE and a SAE. 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.
Infections and infestations Upper respiratory tract infection	2.7% 2/73 The same event may appear as both an AE and a SAE. 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.	2.7% 2/74 The same event may appear as both an AE and a SAE. 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.	1.4% 1/72 The same event may appear as both an AE and a SAE. 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.
Infections and infestations Urinary tract infection	1.4% 1/73 The same event may appear as both an AE and a SAE. 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.	1.4% 1/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Injury, poisoning and procedural complications Fall	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Injury, poisoning and procedural complications Joint sprain	1.4% 1/73 The same event may appear as both an AE and a SAE. 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.	0.00% 0/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Investigations Bacterial test positive	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	0.00% 0/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Investigations Gamma-glutamyltransferase increased	2.7% 2/73 The same event may appear as both an AE and a SAE. 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.	0.00% 0/74 The same event may appear as both an AE and a SAE. 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.	1.4% 1/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Back pain	2.7% 2/73 The same event may appear as both an AE and a SAE. 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.	2.7% 2/74 The same event may appear as both an AE and a SAE. 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.	4.2% 3/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Joint swelling	4.1% 3/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	1.4% 1/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Muscle spasms	2.7% 2/73 The same event may appear as both an AE and a SAE. 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.	2.7% 2/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.5% 4/73 The same event may appear as both an AE and a SAE. 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.	8.1% 6/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Myalgia	4.1% 3/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	2.7% 2/74 The same event may appear as both an AE and a SAE. 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.	4.2% 3/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.4% 1/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Pain in extremity	9.6% 7/73 The same event may appear as both an AE and a SAE. 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.	6.8% 5/74 The same event may appear as both an AE and a SAE. 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.	6.9% 5/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Synovial cyst	1.4% 1/73 The same event may appear as both an AE and a SAE. 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.	2.7% 2/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Musculoskeletal and connective tissue disorders Tendonitis	2.7% 2/73 The same event may appear as both an AE and a SAE. 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.	5.4% 4/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Allodynia	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Decreased vibratory sense	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	0.00% 0/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Dysaesthesia	2.7% 2/73 The same event may appear as both an AE and a SAE. 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.	0.00% 0/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Headache	1.4% 1/73 The same event may appear as both an AE and a SAE. 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.	4.1% 3/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Hyperaesthesia	2.7% 2/73 The same event may appear as both an AE and a SAE. 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.	1.4% 1/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Hypoaesthesia	8.2% 6/73 The same event may appear as both an AE and a SAE. 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.	5.4% 4/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Hyporeflexia	2.7% 2/73 The same event may appear as both an AE and a SAE. 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.	0.00% 0/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Paraesthesia	16.4% 12/73 The same event may appear as both an AE and a SAE. 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.	12.2% 9/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Nervous system disorders Sciatica	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	2.7% 2/74 The same event may appear as both an AE and a SAE. 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.	0.00% 0/72 The same event may appear as both an AE and a SAE. 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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	0.00% 0/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	1.4% 1/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.
Vascular disorders Hypertension	0.00% 0/73 The same event may appear as both an AE and a SAE. 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.	0.00% 0/74 The same event may appear as both an AE and a SAE. 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.	2.8% 2/72 The same event may appear as both an AE and a SAE. 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

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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