Trial Outcomes & Findings for Long Term Safety Study of Tanezumab in Chronic Low Back Pain (NCT NCT00924664)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

849 participants

Primary outcome timeframe

A4091012: Baseline, A4091039: Week 24

Results posted on

2021-04-21

Participant Flow

Participants who received study drug in parent study A4091012 (NCT00876187) were eligible to be enrolled in this study, either at preferred rollover visit(Day 113) or due to early discontinuation in parent study for lack of efficacy. Dosing interval between last dose in parent study and first dose in this study was not less than 8 weeks and not more than 12 weeks.

Participant milestones

Participant milestones
Measure	Tanezumab 10 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Overall Study STARTED	322	527
Overall Study Treated	321	527
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	322	527

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanezumab 10 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Overall Study Adverse Event	23	39
Overall Study Lack of Efficacy	10	15
Overall Study Lost to Follow-up	10	12
Overall Study Withdrawal by Subject	47	71
Overall Study Protocol Violation	2	5
Overall Study Pregnancy	1	1
Overall Study Death	0	2
Overall Study Study terminated by sponsor	199	330
Overall Study Other	29	52
Overall Study Randomized but not Treated	1	0

Baseline Characteristics

Long Term Safety Study of Tanezumab in Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.	Total n=848 Participants Total of all reporting groups
Age, Customized 18 to 44 years	79 Participants n=5 Participants	128 Participants n=7 Participants	207 Participants n=5 Participants
Age, Customized 45 to 64 years	182 Participants n=5 Participants	300 Participants n=7 Participants	482 Participants n=5 Participants
Age, Customized Greater than (>) 64 years	60 Participants n=5 Participants	99 Participants n=7 Participants	159 Participants n=5 Participants
Sex: Female, Male Female	167 Participants n=5 Participants	277 Participants n=7 Participants	444 Participants n=5 Participants
Sex: Female, Male Male	154 Participants n=5 Participants	250 Participants n=7 Participants	404 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 112 days after last dose of study treatment (up to 448 days)

Population: Intent-to-treat (ITT) analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664).

AE: any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	198 Participants	370 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	15 Participants	24 Participants

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 4

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, 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 (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 Baseline	0.89 units on a scale Standard Deviation 2.53	1.14 units on a scale Standard Deviation 2.81
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 Change at Week 4	0.34 units on a scale Standard Deviation 1.37	0.54 units on a scale Standard Deviation 2.12

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 8

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

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

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=295 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=480 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8	0.42 units on a scale Standard Deviation 1.72	0.54 units on a scale Standard Deviation 1.84

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 16

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

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

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=270 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=425 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16	0.39 units on a scale Standard Deviation 1.60	0.42 units on a scale Standard Deviation 1.75

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

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

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=226 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=369 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24	0.35 units on a scale Standard Deviation 1.65	0.46 units on a scale Standard Deviation 1.93

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 32

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

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

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=149 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=241 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32	0.36 units on a scale Standard Deviation 1.54	0.32 units on a scale Standard Deviation 1.47

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 40

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

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

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=69 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=143 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40	0.55 units on a scale Standard Deviation 1.69	0.26 units on a scale Standard Deviation 1.52

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 48

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

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

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=8 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=51 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48	0.75 units on a scale Standard Deviation 2.19	0.18 units on a scale Standard Deviation 1.20

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 56

Population: ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 56 since none of the participants received dosing beyond Week 32 and safety assessment was only required for 16 weeks after treatment discontinuation due to clinical hold.

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

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=10 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56	—	0.70 units on a scale Standard Deviation 2.36

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 4

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 Baseline: Worst Pain	7.09 units on a scale Standard Deviation 1.56	7.29 units on a scale Standard Deviation 1.53
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 Baseline: Least Pain	5.02 units on a scale Standard Deviation 2.09	4.95 units on a scale Standard Deviation 2.02
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 Baseline: Average Pain	6.13 units on a scale Standard Deviation 1.51	6.25 units on a scale Standard Deviation 1.43
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 Baseline: Pain right now	6.22 units on a scale Standard Deviation 2.01	6.22 units on a scale Standard Deviation 1.93
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 Change at Week 4: Worst Pain	-3.68 units on a scale Standard Deviation 2.65	-3.97 units on a scale Standard Deviation 2.81
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 Change at Week 4: Least Pain	-2.88 units on a scale Standard Deviation 2.51	-2.93 units on a scale Standard Deviation 2.43
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 Change at Week 4: Average Pain	-3.22 units on a scale Standard Deviation 2.39	-3.45 units on a scale Standard Deviation 2.38
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 Change at Week 4: Pain right now	-3.70 units on a scale Standard Deviation 2.74	-3.86 units on a scale Standard Deviation 2.73

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 8

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=291 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=479 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 Change at Week 8: Worst Pain	-3.20 units on a scale Standard Deviation 2.67	-3.68 units on a scale Standard Deviation 2.75
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 Change at Week 8: Least Pain	-2.65 units on a scale Standard Deviation 2.49	-2.83 units on a scale Standard Deviation 2.44
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 Change at Week 8: Average Pain	-2.92 units on a scale Standard Deviation 2.30	-3.36 units on a scale Standard Deviation 2.36
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 Change at Week 8: Pain right now	-3.27 units on a scale Standard Deviation 2.71	-3.63 units on a scale Standard Deviation 2.78

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 16

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=244 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=378 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 Change at Week 16: Worst Pain	-3.30 units on a scale Standard Deviation 2.83	-3.58 units on a scale Standard Deviation 2.72
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 Change at Week 16: Least Pain	-2.75 units on a scale Standard Deviation 2.42	-2.73 units on a scale Standard Deviation 2.40
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 Change at Week 16: Average Pain	-3.00 units on a scale Standard Deviation 2.41	-3.34 units on a scale Standard Deviation 2.38
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 Change at Week 16: Pain right now	-3.42 units on a scale Standard Deviation 2.67	-3.68 units on a scale Standard Deviation 2.67

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=155 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=258 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 Change at Week 24: Worst Pain	-3.45 units on a scale Standard Deviation 2.80	-3.55 units on a scale Standard Deviation 2.74
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 Change at Week 24: Least Pain	-2.79 units on a scale Standard Deviation 2.44	-2.63 units on a scale Standard Deviation 2.34
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 Change at Week 24: Average Pain	-3.14 units on a scale Standard Deviation 2.40	-3.31 units on a scale Standard Deviation 2.29
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 Change at Week 24: Pain right now	-3.50 units on a scale Standard Deviation 2.80	-3.59 units on a scale Standard Deviation 2.66

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 32

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=68 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=128 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 Change at Week 32: Worst Pain	-3.26 units on a scale Standard Deviation 2.90	-3.80 units on a scale Standard Deviation 2.61
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 Change at Week 32: Least Pain	-2.50 units on a scale Standard Deviation 2.88	-2.68 units on a scale Standard Deviation 2.35
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 Change at Week 32: Average Pain	-2.82 units on a scale Standard Deviation 2.63	-3.23 units on a scale Standard Deviation 2.18
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 Change at Week 32: Pain right now	-3.35 units on a scale Standard Deviation 2.96	-3.77 units on a scale Standard Deviation 2.43

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 40

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=8 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=37 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 Change at Week 40: Worst Pain	-3.88 units on a scale Standard Deviation 2.42	-3.49 units on a scale Standard Deviation 2.67
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 Change at Week 40: Least Pain	-2.75 units on a scale Standard Deviation 2.76	-2.43 units on a scale Standard Deviation 1.91
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 Change at Week 40: Average Pain	-2.75 units on a scale Standard Deviation 3.01	-2.97 units on a scale Standard Deviation 2.28
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 Change at Week 40: Pain right now	-3.13 units on a scale Standard Deviation 3.60	-3.57 units on a scale Standard Deviation 2.44

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 48

Population: ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 48 since none of the participants received dosing beyond Week 32 and efficacy assessment was not required after clinical hold.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=7 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 Change at Week 48: Worst Pain	—	-2.43 units on a scale Standard Deviation 2.44
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 Change at Week 48: Least Pain	—	-0.86 units on a scale Standard Deviation 1.95
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 Change at Week 48: Average Pain	—	-2.14 units on a scale Standard Deviation 2.12
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 Change at Week 48: Pain right now	—	-2.00 units on a scale Standard Deviation 2.38

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 56

Population: Data was not collected at Week 56 since efficacy assessment was not required after clinical hold.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 4

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=525 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Baseline: Composite score	5.36 units on a scale Standard Deviation 2.11	5.37 units on a scale Standard Deviation 1.91
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Change at Week 4: General Activity	-3.39 units on a scale Standard Deviation 2.76	-3.45 units on a scale Standard Deviation 2.81
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Change at Week 4: Walking Ability	-2.85 units on a scale Standard Deviation 2.88	-3.15 units on a scale Standard Deviation 2.85
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Change at Week 4: Normal Work	-3.15 units on a scale Standard Deviation 2.71	-3.49 units on a scale Standard Deviation 2.80
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Baseline: General Activity	5.91 units on a scale Standard Deviation 2.08	5.87 units on a scale Standard Deviation 2.10
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Baseline: Walking Ability	5.22 units on a scale Standard Deviation 2.50	5.40 units on a scale Standard Deviation 2.34
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Baseline: Normal Work	5.74 units on a scale Standard Deviation 2.18	5.94 units on a scale Standard Deviation 2.11
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Baseline: Sleep	5.97 units on a scale Standard Deviation 2.61	5.86 units on a scale Standard Deviation 2.50
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Change at Week 4: Sleep	-3.53 units on a scale Standard Deviation 3.13	-3.45 units on a scale Standard Deviation 2.98
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 Change at Week 4: Composite score	-3.09 units on a scale Standard Deviation 2.52	-3.21 units on a scale Standard Deviation 2.45

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 8

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=291 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=478 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 Change at Week 8: General Activity	-2.99 units on a scale Standard Deviation 2.65	-3.36 units on a scale Standard Deviation 2.88
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 Change at Week 8: Walking Ability	-2.58 units on a scale Standard Deviation 2.68	-3.00 units on a scale Standard Deviation 2.89
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 Change at Week 8: Normal Work	-2.77 units on a scale Standard Deviation 2.62	-3.32 units on a scale Standard Deviation 2.90
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 Change at Week 8: Sleep	-3.15 units on a scale Standard Deviation 3.06	-3.34 units on a scale Standard Deviation 2.96
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 Change at Week 8: Composite score	-2.74 units on a scale Standard Deviation 2.40	-3.09 units on a scale Standard Deviation 2.52

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 16

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=244 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=376 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 Change at Week 16: General Activity	-3.20 units on a scale Standard Deviation 2.81	-3.26 units on a scale Standard Deviation 2.89
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 Change at Week 16: Walking Ability	-2.55 units on a scale Standard Deviation 2.76	-2.94 units on a scale Standard Deviation 2.93
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 Change at Week 16: Normal Work	-2.83 units on a scale Standard Deviation 2.61	-3.26 units on a scale Standard Deviation 2.84
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 Change at Week 16: Sleep	-3.19 units on a scale Standard Deviation 2.93	-3.34 units on a scale Standard Deviation 2.94
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 Change at Week 16: Composite score	-2.76 units on a scale Standard Deviation 2.44	-3.05 units on a scale Standard Deviation 2.51

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=155 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=256 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 Change at Week 24: General Activity	-3.12 units on a scale Standard Deviation 2.87	-3.25 units on a scale Standard Deviation 2.95
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 Change at Week 24: Walking Ability	-2.70 units on a scale Standard Deviation 2.84	-2.90 units on a scale Standard Deviation 2.81
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 Change at Week 24: Normal Work	-3.06 units on a scale Standard Deviation 2.80	-3.25 units on a scale Standard Deviation 2.77
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 Change at Week 24: Sleep	-3.47 units on a scale Standard Deviation 2.91	-3.42 units on a scale Standard Deviation 2.96
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 Change at Week 24: Composite score	-2.90 units on a scale Standard Deviation 2.52	-3.03 units on a scale Standard Deviation 2.50

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 32

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=68 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=127 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 Change at Week 32: General Activity	-2.47 units on a scale Standard Deviation 3.21	-3.17 units on a scale Standard Deviation 2.67
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 Change at Week 32: Walking Ability	-2.32 units on a scale Standard Deviation 3.26	-2.74 units on a scale Standard Deviation 2.78
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 Change at Week 32: Normal Work	-2.74 units on a scale Standard Deviation 3.31	-3.20 units on a scale Standard Deviation 2.65
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 Change at Week 32: Sleep	-3.10 units on a scale Standard Deviation 3.22	-3.47 units on a scale Standard Deviation 2.91
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 Change at Week 32: Composite score	-2.52 units on a scale Standard Deviation 3.09	-2.94 units on a scale Standard Deviation 2.32

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 40

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=8 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=37 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 Change at Week 40: General Activity	-2.88 units on a scale Standard Deviation 3.04	-2.46 units on a scale Standard Deviation 2.55
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 Change at Week 40: Walking Ability	-2.13 units on a scale Standard Deviation 2.53	-2.59 units on a scale Standard Deviation 2.73
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 Change at Week 40: Normal Work	-2.63 units on a scale Standard Deviation 3.38	-2.73 units on a scale Standard Deviation 2.36
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 Change at Week 40: Sleep	-3.13 units on a scale Standard Deviation 3.72	-3.41 units on a scale Standard Deviation 2.62
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 Change at Week 40: Composite score	-2.27 units on a scale Standard Deviation 3.18	-2.72 units on a scale Standard Deviation 2.28

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 48

Population: ITT analysis set. 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 48 since none of the participants received dosing beyond Week 32 and efficacy assessment was not required after clinical hold.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=7 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 Change at Week 48: General Activity	—	-1.71 units on a scale Standard Deviation 2.21
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 Change at Week 48: Walking Ability	—	-1.71 units on a scale Standard Deviation 2.21
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 Change at Week 48: Normal Work	—	-1.57 units on a scale Standard Deviation 1.99
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 Change at Week 48: Sleep	—	-2.43 units on a scale Standard Deviation 1.13
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 Change at Week 48: Composite score	—	-1.76 units on a scale Standard Deviation 1.53

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 56

Population: Data was not collected at Week 56 since efficacy assessment was not required after clinical hold.

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 4

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=320 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=525 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4 Baseline	13.01 units on a scale Standard Deviation 5.13	12.66 units on a scale Standard Deviation 4.85
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4 Change at Week 4	-5.52 units on a scale Standard Deviation 5.73	-5.35 units on a scale Standard Deviation 5.47

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 8

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=245 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=399 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8	-4.86 units on a scale Standard Deviation 5.14	-5.02 units on a scale Standard Deviation 5.71

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 16

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=202 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=310 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16	-4.90 units on a scale Standard Deviation 5.84	-5.19 units on a scale Standard Deviation 5.36

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=126 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=210 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24	-4.79 units on a scale Standard Deviation 5.64	-5.30 units on a scale Standard Deviation 5.61

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 32

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=59 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=107 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32	-5.36 units on a scale Standard Deviation 5.87	-5.07 units on a scale Standard Deviation 5.46

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 40

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=8 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=32 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40	-6.00 units on a scale Standard Deviation 6.32	-4.13 units on a scale Standard Deviation 6.32

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 48

Population: ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 48 since none of the participants received dosing beyond Week 32 and efficacy assessment was not required after clinical hold.

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=6 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48	—	-2.67 units on a scale Standard Deviation 6.02

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 56

Population: Data was not collected at Week 56 since efficacy assessment was not required after clinical hold.

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 4

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4 Baseline	3.38 units on a scale Standard Deviation 0.57	3.36 units on a scale Standard Deviation 0.56
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4 Change at Week 4	-1.17 units on a scale Standard Deviation 1.00	-1.21 units on a scale Standard Deviation 1.00

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 8

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=291 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=480 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8	-0.97 units on a scale Standard Deviation 0.97	-1.07 units on a scale Standard Deviation 1.01

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 16

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=244 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=376 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16	-1.05 units on a scale Standard Deviation 1.02	-1.03 units on a scale Standard Deviation 0.96

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 24

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=154 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=258 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24	-1.09 units on a scale Standard Deviation 0.95	-1.05 units on a scale Standard Deviation 1.01

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 32

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=68 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=128 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32	-1.07 units on a scale Standard Deviation 1.14	-1.05 units on a scale Standard Deviation 0.98

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 40

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=8 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=37 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40	-1.25 units on a scale Standard Deviation 1.04	-0.95 units on a scale Standard Deviation 1.03

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 48

Population: ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 48 since none of the participants received dosing beyond Week 32 and efficacy assessment was not required after clinical hold.

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=7 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48	—	-0.43 units on a scale Standard Deviation 0.79

PRIMARY outcome

Timeframe: A4091012: Baseline, A4091039: Week 56

Population: Data was not collected at Week 56 since efficacy assessment was not required after clinical hold.

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Week 56

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664).

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Time to Discontinuation Due to Lack of Efficacy	NA days Median and full range were not evaluable since very few participants discontinued due to lack of efficacy.	NA days Median and full range were not evaluable since very few participants discontinued due to lack of efficacy.

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 8, 24, 40, 56, 64

Population: Pharmacokinetic(PK) analysis set: participants who received at least 1 dose of IV or SC study medication during this study, A4091039(NCT00924664), had at least 1 plasma concentration value above LLOQ. 'Overall Number of Participants Analyzed' signifies participants evaluable for this measure, 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively. Due to clinical hold, study was terminated prematurely, data was not collected at Week 64.

Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=268 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=433 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Plasma Concentration of Tanezumab Baseline	393.519 nanogram/milliliter (ng/mL) Standard Deviation 659.8150	427.871 nanogram/milliliter (ng/mL) Standard Deviation 771.2499
Plasma Concentration of Tanezumab Week 8	596.957 nanogram/milliliter (ng/mL) Standard Deviation 533.8274	1074.76 nanogram/milliliter (ng/mL) Standard Deviation 527.5588
Plasma Concentration of Tanezumab Week 24	588.216 nanogram/milliliter (ng/mL) Standard Deviation 296.7509	1276.75 nanogram/milliliter (ng/mL) Standard Deviation 770.0278
Plasma Concentration of Tanezumab Week 40	542.571 nanogram/milliliter (ng/mL) Standard Deviation 240.5285	1058.92 nanogram/milliliter (ng/mL) Standard Deviation 666.4789
Plasma Concentration of Tanezumab Week 56	250.512 nanogram/milliliter (ng/mL) Standard Deviation 393.9501	502.320 nanogram/milliliter (ng/mL) Standard Deviation 676.1049

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 8, 24, 40, 56, 64

Population: ITT analysis set. 'Overall number of participants analyzed' signifies participants evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively. Data was not collected at Week 64 since assessment was only required for 16 weeks after treatment discontinuation due to clinical hold.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=270 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=430 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Total Nerve Growth Factor (NGF) Concentration Week 8	3771.1 picogram/milliliter Standard Deviation 1472.3	4470.2 picogram/milliliter Standard Deviation 1773.6
Total Nerve Growth Factor (NGF) Concentration Baseline	2599.9 picogram/milliliter Standard Deviation 1893.7	2025.4 picogram/milliliter Standard Deviation 2281.4
Total Nerve Growth Factor (NGF) Concentration Week 24	4132.7 picogram/milliliter Standard Deviation 1780.1	4860.6 picogram/milliliter Standard Deviation 1990.6
Total Nerve Growth Factor (NGF) Concentration Week 40	4314.0 picogram/milliliter Standard Deviation 1372.4	4446.7 picogram/milliliter Standard Deviation 1807.1
Total Nerve Growth Factor (NGF) Concentration Week 56	2855.5 picogram/milliliter Standard Deviation 1651.8	3639.3 picogram/milliliter Standard Deviation 1990.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 56

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664).

Food and Drug Administration (FDA) approved analgesics and muscle relaxants were permitted as concomitant medications for CLBP and were prescribed as per investigator's discretion. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drug (NSAIDs), capsaicin products, oral/injectable corticosteroids, and viscosupplementation (eg, hyaluronan).

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP)	150 Participants	268 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: A4091012: Baseline, A4091039: Week 24, 56

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively.

WPAI:SHP: 6-item, binary question on current employment, 3 questions on hours of work and work-loss, 2 questions based on 0-10 point scale to judge how CLBP affects ability to work, perform regular activities(0=no effect on work/activity, 10=completely prevented from working/activity). Four scores derived as percent: activity impairment, impairment while working, overall work impairment, work time missed. Total possible score: 0-100 (0=no impairment/high productivity, 100=completely impaired/low activity). Each of 4 scores expressed as impairment percentages, high percentage=more impairment, less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Baseline:impairment during work	48.77 percentage of impairment Standard Deviation 23.56	47.98 percentage of impairment Standard Deviation 23.66
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Baseline:activity impairment	58.19 percentage of impairment Standard Deviation 23.05	58.74 percentage of impairment Standard Deviation 21.24
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Baseline:overall impairment	8.23 percentage of impairment Standard Deviation 23.11	7.46 percentage of impairment Standard Deviation 21.97
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Baseline:work time missed	2.99 percentage of impairment Standard Deviation 10.81	2.27 percentage of impairment Standard Deviation 8.67
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Change at Week 24:activity impairment	-25.29 percentage of impairment Standard Deviation 27.64	-26.34 percentage of impairment Standard Deviation 28.55
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Change at Week 24:impairment during work	-26.30 percentage of impairment Standard Deviation 24.79	-21.36 percentage of impairment Standard Deviation 26.84
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Change at Week 24:overall impairment	-4.63 percentage of impairment Standard Deviation 23.62	-3.25 percentage of impairment Standard Deviation 21.39
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Change at Week 24:work time missed	-1.49 percentage of impairment Standard Deviation 10.33	-0.50 percentage of impairment Standard Deviation 8.24
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Change at Week 56:activity impairment	—	-8.00 percentage of impairment Standard Deviation 34.58
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Change at Week 56:impairment during work	—	-10.00 percentage of impairment Standard Deviation 28.28
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Change at Week 56:overall impairment	—	1.75 percentage of impairment Standard Deviation 16.76
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 Change at Week 56:work time missed	—	1.41 percentage of impairment Standard Deviation 4.71

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Week 8, 24, 40, 56, 64

Population: ITT analysis set. 'Overall number of participants analyzed'=participants evaluable for this measure at any time point. 'Number Analyzed' signifies participants evaluated at specific time points for each arm, respectively. Data was not analyzed at Week 64 since safety assessment was only required for 16 weeks after treatment discontinuation due to clinical hold.

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

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=269 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=435 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Number of Participants Who Developed Anti-Tanezumab Antibodies Baseline	1 Participants	0 Participants
Number of Participants Who Developed Anti-Tanezumab Antibodies Week 8	4 Participants	1 Participants
Number of Participants Who Developed Anti-Tanezumab Antibodies Week 24	3 Participants	1 Participants
Number of Participants Who Developed Anti-Tanezumab Antibodies Week 40	0 Participants	0 Participants
Number of Participants Who Developed Anti-Tanezumab Antibodies Week 56	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Week 4, 8, 16, 24, 32 for intravenous infusion; Week 24, 32, 40, 56, 64 for subcutaneous injection

Population: ITT analysis set. Data was not analyzed at Week 64 for SC injection since safety assessment was only required for 16 weeks after treatment discontinuation due to clinical hold.

The injection and infusion site reactions were assessed based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after administration (not related to needle insertion pain) of subcutaneous injection or intravenous infusion.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Number of Participants With Injection and Infusion Site Reactions Baseline: Infusion site	7 Participants	7 Participants
Number of Participants With Injection and Infusion Site Reactions Week 4: Infusion site	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 8: Infusion site	5 Participants	5 Participants
Number of Participants With Injection and Infusion Site Reactions Week 16: Infusion site	4 Participants	5 Participants
Number of Participants With Injection and Infusion Site Reactions Week 24: Infusion site	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 32: Infusion site	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 24: Injection site	2 Participants	4 Participants
Number of Participants With Injection and Infusion Site Reactions Week 32: Injection site	0 Participants	2 Participants
Number of Participants With Injection and Infusion Site Reactions Week 40: Injection site	0 Participants	0 Participants
Number of Participants With Injection and Infusion Site Reactions Week 56: Injection site	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Week 56

Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664).

Number of participants are reported based on the maximum number of intravenous (IV) and subcutaneous (SC) doses of tanezumab received.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mg n=321 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 Participants Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication Number of SC Doses: 3	1 Participants	7 Participants
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication Number of IV Doses: 1	59 Participants	102 Participants
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication Number of IV Doses: 2	93 Participants	145 Participants
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication Number of IV Doses: 3	169 Participants	276 Participants
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication Number of IV Doses: 4	0 Participants	3 Participants
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication Number of IV Doses: 5	0 Participants	1 Participants
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication Number of SC Doses: 1	71 Participants	111 Participants
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication Number of SC Doses: 2	8 Participants	42 Participants

Adverse Events

Tanezumab 10 mg

Serious events: 15 serious events

Other events: 152 other events

Deaths: 0 deaths

Tanezumab 20 mg

Serious events: 24 serious events

Other events: 277 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Tanezumab 10 mg n=321 participants at risk Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.	Tanezumab 20 mg n=527 participants at risk Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
Gastrointestinal disorders Diarrhoea	1.9% 6/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.4% 18/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
General disorders Infusion site reaction	3.7% 12/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 17/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
General disorders Oedema peripheral	3.4% 11/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	6.1% 32/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Nasopharyngitis	1.6% 5/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.5% 13/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Sinusitis	3.7% 12/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.7% 14/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Upper respiratory tract infection	3.4% 11/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	4.9% 26/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Urinary tract infection	2.8% 9/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.5% 13/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Injury, poisoning and procedural complications Fall	2.2% 7/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.8% 15/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Injury, poisoning and procedural complications Muscle strain	2.5% 8/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 17/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Arthralgia	12.8% 41/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	14.4% 76/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Back pain	3.1% 10/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 17/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Joint swelling	1.9% 6/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.0% 16/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Muscle spasms	2.2% 7/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.8% 15/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.4% 14/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	4.2% 22/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Myalgia	1.9% 6/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.4% 18/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Osteoarthritis	2.8% 9/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.7% 14/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 12/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	7.2% 38/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Allodynia	0.00% 0/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.1% 11/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Decreased vibratory sense	0.62% 2/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.7% 14/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Headache	3.1% 10/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	5.1% 27/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Hyperaesthesia	0.93% 3/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.1% 11/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Hypoaesthesia	7.2% 23/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	7.8% 41/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Paraesthesia	9.7% 31/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	10.6% 56/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Skin and subcutaneous tissue disorders Rash	0.62% 2/321 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.1% 11/527 Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492