Long Term Safety Study of Tanezumab in Chronic Low Back Pain

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00924664
• Collaborator: (none)
• Enrollment: 849
• Locations: 149
• Arms: 2
• Actual Duration (Months): 22
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the safety and efficacy of tanezumab for chronic low back pain. Patients who were randomized and treated with study medication in a previous chronic low back pain "parent" study will be eligible to enroll in this safety extension study at the Preferred Rollover Time Point visit or at the Early Termination visit of the parent study upon discontinuation due to lack of efficacy.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Biological: Tanezumab 20 mg; Biological: Tanezumab 10 mg	Phase 2

Detailed Description

This study was terminated on 30 November 2010 following a US FDA clinical hold for tanezumab chronic low back pain clinical studies which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.

Study Design

• Study Type: Interventional
• Actual Enrollment: 849 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A RANDOMIZED, MULTICENTER, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC LOW BACK PAIN
• Actual Study Start Date: Aug 20, 2009
• Actual Primary Completion Date: Nov 30, 2010
• Actual Study Completion Date: Jun 22, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tanezumab 20 mg	Biological: Tanezumab 20 mg; Tanezumab 20 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks
Experimental: Tanezumab 10 mg	Biological: Tanezumab 10 mg; Tanezumab 10 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 112 days after last dose of study treatment (up to 448 days)]

   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.

2. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 [A4091012: Baseline, A4091039: Week 4]

   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.

3. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8 [A4091012: Baseline, A4091039: Week 8]

   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.

4. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16 [A4091012: Baseline, A4091039: Week 16]

   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.

5. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24 [A4091012: Baseline, A4091039: Week 24]

   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.

6. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32 [A4091012: Baseline, A4091039: Week 32]

   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.

7. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40 [A4091012: Baseline, A4091039: Week 40]

   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.

8. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48 [A4091012: Baseline, A4091039: Week 48]

   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.

9. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56 [A4091012: Baseline, A4091039: Week 56]

   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.

10. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 [A4091012: Baseline, A4091039: Week 4]

    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).

11. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 [A4091012: Baseline, A4091039: Week 8]

    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).

12. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 [A4091012: Baseline, A4091039: Week 16]

    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).

13. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 [A4091012: Baseline, A4091039: Week 24]

    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).

14. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 [A4091012: Baseline, A4091039: Week 32]

    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).

15. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 [A4091012: Baseline, A4091039: Week 40]

    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).

16. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 [A4091012: Baseline, A4091039: Week 48]

    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).

17. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56 [A4091012: Baseline, A4091039: Week 56]

    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).

18. 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 [A4091012: Baseline, A4091039: Week 4]

    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.

19. 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 [A4091012: Baseline, A4091039: Week 8]

    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.

20. 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 [A4091012: Baseline, A4091039: Week 16]

    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.

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 24 [A4091012: Baseline, A4091039: Week 24]

    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.

22. 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 [A4091012: Baseline, A4091039: Week 32]

    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.

23. 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 [A4091012: Baseline, A4091039: Week 40]

    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.

24. 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 [A4091012: Baseline, A4091039: Week 48]

    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.

25. 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 56 [A4091012: Baseline, A4091039: Week 56]

    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.

26. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4 [A4091012: Baseline, A4091039: Week 4]

    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.

27. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8 [A4091012: Baseline, A4091039: Week 8]

    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.

28. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16 [A4091012: Baseline, A4091039: Week 16]

    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.

29. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24 [A4091012: Baseline, A4091039: Week 24]

    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.

30. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32 [A4091012: Baseline, A4091039: Week 32]

    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.

31. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40 [A4091012: Baseline, A4091039: Week 40]

    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.

32. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48 [A4091012: Baseline, A4091039: Week 48]

    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.

33. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56 [A4091012: Baseline, A4091039: Week 56]

    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.

34. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4 [A4091012: Baseline, A4091039: Week 4]

    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).

35. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8 [A4091012: Baseline, A4091039: Week 8]

    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).

36. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16 [A4091012: Baseline, A4091039: Week 16]

    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).

37. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24 [A4091012: Baseline, A4091039: Week 24]

    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).

38. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32 [A4091012: Baseline, A4091039: Week 32]

    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).

39. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40 [A4091012: Baseline, A4091039: Week 40]

    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).

40. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48 [A4091012: Baseline, A4091039: Week 48]

    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).

41. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56 [A4091012: Baseline, A4091039: Week 56]

    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).

Secondary Outcome Measures

1. Time to Discontinuation Due to Lack of Efficacy [Baseline up to Week 56]

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

2. Plasma Concentration of Tanezumab [Baseline (Day 1), Week 8, 24, 40, 56, 64]

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

3. Total Nerve Growth Factor (NGF) Concentration [Baseline (Day 1), Week 8, 24, 40, 56, 64]

Other Outcome Measures

1. Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP) [Baseline up to Week 56]

   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).

2. Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 [A4091012: Baseline, A4091039: Week 24, 56]

   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.

3. Number of Participants Who Developed Anti-Tanezumab Antibodies [Baseline (Day 1), Week 8, 24, 40, 56, 64]

   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.

4. Number of Participants With Injection and Infusion Site Reactions [Baseline (Day 1), Week 4, 8, 16, 24, 32 for intravenous infusion; Week 24, 32, 40, 56, 64 for subcutaneous injection]

   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.

5. Number of Participants With Intravenous and Subcutaneous Doses of Study Medication [Day 1 up to Week 56]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent prior to completing any of the study procedures.

• Female patients must meet one of the following criteria:

1. Female patients of non childbearing potential - Must be post menopausal, defined as women who are >=45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the parent double blind CLBP study; or Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy.

2.) Female patients of child bearing potential: must not be pregnant or lactating, and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method), and must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing

• Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential.

• Females of child bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the last dose of IV study medication.

• Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures

• Patient has been treated in a parent tanezumab double blind CLBP study

• Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy. At least eight weeks but no more than 12 weeks have elapsed since the last study medication infusion in the parent study. Patients are permitted to enter the extension study up to 12 weeks after their last dose of study medication in their parent study (or 4 weeks after the End of Treatment visit)

Exclusion Criteria:

• Failed screening in a parent tanezumab double blind CLBP study

• Withdrawn from a parent tanezumab double blind CLBP study for an adverse event

• Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to become pregnant during the course of clinical study

• Use of any investigational medication within 30 days prior to Baseline (3 months for any investigational biological other than tanezumab) or plans to receive an investigational medication other than the study medication during the course of this study

• Patients who exited the parent double blind CLBP study because of lack of compliance, protocol violation (including not meeting entrance criteria), no longer willing to participate (for reasons other than lack of efficacy), or were lost to follow up in the parent double blind study

• Patients who were randomized into the parent study in violation of inclusion or exclusion criteria but who were not withdrawn from the parent study;

• Any other condition, which in the opinion of the Investigator, would put the patient at increased safety risk or otherwise make the patient unsuitable for this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnacle Research Group, LLC	Anniston	Alabama	United States	36201
2	Pinnacle Research Group, Anniston Medical Clinic	Anniston	Alabama	United States	36207
3	Pinnacle Research Group	Anniston	Alabama	United States	36207
4	Simon Williamson Clinic, PC	Birmingham	Alabama	United States	35211
5	Simon-Williamson Clinic, PC	Hueytown	Alabama	United States	35023
6	Saadat Ansari, MD	Huntsville	Alabama	United States	35801
7	Alabama Orthopaedic Clinic	Mobile	Alabama	United States	36608
8	Horizon Research Group	Mobile	Alabama	United States	36608
9	Phoenix Diagnostic Imaging	Chandler	Arizona	United States	85224
10	Radiant Research - Phoenix Southeast	Chandler	Arizona	United States	85224
11	Simon Med	Mesa	Arizona	United States	85202
12	Pivotal Research Centers	Peoria	Arizona	United States	85381
13	Sun Radiology	Peoria	Arizona	United States	85381
14	Arizona Research Center, LLC	Phoenix	Arizona	United States	85023
15	Radiant Research	Scottsdale	Arizona	United States	85251
16	Scottsdale Medical Imaging	Scottsdale	Arizona	United States	85251
17	Premiere Phamaceutical Research, LLC	Tempe	Arizona	United States	85282
18	Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC	Tempe	Arizona	United States	85283
19	Little Rock Family Practice Clinic	Little Rock	Arkansas	United States	72205
20	Providence Clinical Research	Burbank	California	United States	91505
21	Valley Research	Fresno	California	United States	93720
22	Collaborative Neuroscience Network, Inc.	Garden Grove	California	United States	92845
23	University of California San Diego	La Jolla	California	United States	92121
24	Samaritan Center for Medical Research Medical Group	Los Gatos	California	United States	95032
25	Newport Diagnostic Center	Newport Beach	California	United States	92660
26	North County Clinical Research (NCCR)	Oceanside	California	United States	92056
27	Advances in Medicine	Rancho Mirage	California	United States	92270
28	Trinity Medical Research	Roseville	California	United States	95661
29	Center for Clinical Trials of Sacramento, Inc.	Sacramento	California	United States	95823
30	Wetlin Research Associates, Inc	San Diego	California	United States	92120
31	Inland Rheumatology & Osteoporosis Medical Group, Inc.	Upland	California	United States	91786
32	Elite Clinical Trials, Inc.	Wildomar	California	United States	92595
33	Alpine Clinical Research Center	Boulder	Colorado	United States	80304
34	Clinicos, LLC	Colorado Springs	Colorado	United States	80904
35	Advanced Radiology	Stamford	Connecticut	United States	06902
36	Stamford Therapeutics Consortium	Stamford	Connecticut	United States	06905
37	New England Research Associates, LLC	Trumbull	Connecticut	United States	06611
38	Southeast Clinical Research, LLC	Chiefland	Florida	United States	32626
39	Southeast Clinical Research	Chiefland	Florida	United States	32626
40	Doctors Medical Center	DeFuniak Springs	Florida	United States	32435
41	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
42	SJS Clinical Research, Inc.	Destin	Florida	United States	32541
43	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
44	Southeast Clinical Research, LLC	Jacksonville	Florida	United States	32216
45	Collier Neurologic Specialists	Naples	Florida	United States	34102
46	Compass Research, LLC	Orlando	Florida	United States	32806
47	Palm Beach Gardens Open Imaging Center	Palm Beach Gardens	Florida	United States	33410
48	University Clinical Research	Pembroke Pines	Florida	United States	33024
49	Advent Clinical Research Center	Pinellas Park	Florida	United States	33781
50	Meridien Research	Saint Petersburg	Florida	United States	33709
51	St Petersburg General Hospital - X-Rays only	Saint Petersburg	Florida	United States	33710
52	Dale G. Bramlet, MD., P.L.	Saint Petersburg	Florida	United States	33713
53	Miami Research Associates	South Miami	Florida	United States	33143
54	Palm Beach Research Center	West Palm Beach	Florida	United States	33404
55	MD Now Urgent Care	West Palm Beach	Florida	United States	33409
56	Midtown Imaging	West Palm Beach	Florida	United States	33417
57	Center for Prospective Outcome Studies	Atlanta	Georgia	United States	30327
58	Southeastern Radiology Associates, LLC	Atlanta	Georgia	United States	30327
59	River Birch Research Alliance, LLC	Blue Ridge	Georgia	United States	30513
60	CT: Marietta Imaging Center LLC	Marietta	Georgia	United States	30060
61	Drug Studies America	Marietta	Georgia	United States	30060
62	Selah Medical Center, PA	Boise	Idaho	United States	83704
63	Advanced Diagnostic Imaging (ADI)	Evansville	Indiana	United States	47714
64	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
65	Diagnostic Imaging Centers	Overland Park	Kansas	United States	66211
66	Clinical Trials Technology, Inc.	Prairie Village	Kansas	United States	66206
67	Cotton-O'Neil Clinical Research Center	Topeka	Kansas	United States	66606
68	Cotton-O'Neil Clinic	Topeka	Kansas	United States	66606
69	Central Kentucky Research Associates, Inc.	Lexington	Kentucky	United States	40509
70	Commonwealth Biomedical Research	Madisonville	Kentucky	United States	42431
71	Arthritis and Diabetes Clinic	Monroe	Louisiana	United States	71203
72	Office of Peter A. Holt, MD	Baltimore	Maryland	United States	21239
73	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01610
74	The Center for Clinical Trials	Biloxi	Mississippi	United States	39531
75	Clinical Research Center of Jackson	Jackson	Mississippi	United States	39202
76	Physician's Surgery Center	Jackson	Mississippi	United States	39202
77	Medex Healthcare Research, Inc.	Saint Louis	Missouri	United States	63117
78	Mercy Health Research	Saint Louis	Missouri	United States	63141
79	Clinvest, A Division of Banyan Group, Inc	Springfield	Missouri	United States	65807
80	Quality Clinical Research, Inc.	Omaha	Nebraska	United States	68114
81	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
82	Clinical Research Consortium	Las Vegas	Nevada	United States	89119
83	Mirkil Medical	Las Vegas	Nevada	United States	89119
84	Advanced Biomedical Research of America	Las Vegas	Nevada	United States	89123
85	Comprehensive Clinical Research	Berlin	New Jersey	United States	08009
86	Booth Radiology	Stratford	New Jersey	United States	08084
87	CRI Worldwide, LLC	Willingboro	New Jersey	United States	08046
88	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico	United States	87102
89	Central New York Clinical Research	Manlius	New York	United States	13104
90	Medex Healthcare Research	New York	New York	United States	10004
91	The Medical Research Network, LLC	New York	New York	United States	10128
92	B & I Imaging	Rochester	New York	United States	14609
93	Rochester Clinical Research, Inc.	Rochester	New York	United States	14609
94	Finger Lakes Clinical Research	Rochester	New York	United States	14618
95	Upstate Clinical Research Associates	Williamsville	New York	United States	14221
96	Greensboro Imaging	Greensboro	North Carolina	United States	27407
97	Pharmquest	Greensboro	North Carolina	United States	27408
98	Caldwell Memorial Hospital	Lenoir	North Carolina	United States	28645
99	Northstate Clinical Research, PLLC	Lenoir	North Carolina	United States	28645
100	Wake Internal Medicine Consultants, Inc.	Raleigh	North Carolina	United States	27612
101	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
102	The Center for Clinical Research	Winston-Salem	North Carolina	United States	27103
103	Rapid Medical Research, Inc.	Cleveland	Ohio	United States	44122
104	Christine Codding, MD	Oklahoma City	Oklahoma	United States	73103
105	Health Research of Oklahoma	Oklahoma City	Oklahoma	United States	73103
106	McBride Clinic, Inc	Oklahoma City	Oklahoma	United States	73103
107	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
108	Medford Medical Clinic, LLP	Medford	Oregon	United States	95704
109	Rogue Valley Medical Center	Medford	Oregon	United States	97504
110	Sunstone Research	Medford	Oregon	United States	97504
111	Summit Research Network (Oregon), Inc.	Portland	Oregon	United States	97210
112	Allegheny Pain Management	Altoona	Pennsylvania	United States	16602
113	Blair Medical Associates-Radiology	Altoona	Pennsylvania	United States	16602
114	Paramount Clinical Research	Bridgeville	Pennsylvania	United States	15017
115	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
116	CRI Worldwide LLC	Philadelphia	Pennsylvania	United States	19139
117	New England Center for Clinical Research	Cranston	Rhode Island	United States	02920
118	Omega Medical Research	Warwick	Rhode Island	United States	02886
119	Columbia Arthritis Center, P.A.	Columbia	South Carolina	United States	29204
120	Southern Orthopaedic Sports Medicine	Columbia	South Carolina	United States	29204
121	Radiant Research	Greer	South Carolina	United States	29651
122	Health Concepts	Rapid City	South Dakota	United States	57702
123	SCRI Research Center, LLC	Germantown	Tennessee	United States	38138
124	Wolf River Medical Group, LLC	Germantown	Tennessee	United States	38138
125	Advanced Therapeutics, Inc.	Johnson City	Tennessee	United States	37601
126	FutureSearch Trials of Neurology	Austin	Texas	United States	78731
127	DiscoveResearch, Inc.	Beaumont	Texas	United States	77701
128	Beaumont Internal Medicine & Geriatric Associates	Beaumont	Texas	United States	77702
129	DiscoveResearch Incorporated	Bryan	Texas	United States	77802
130	Punzi Medical Center	Carrollton	Texas	United States	75006
131	KRK Medical Research	Dallas	Texas	United States	75230
132	Advances In Health, Inc.	Houston	Texas	United States	77030
133	St. Luke's Diagnostic & Treatment Center Kirby Glen	Houston	Texas	United States	77030
134	Centex Research Inc.	Houston	Texas	United States	77062
135	Centex Research	Houston	Texas	United States	77065
136	Centex Research	Nassau Bay	Texas	United States	77058
137	Paragon Research Center	San Antonio	Texas	United States	78205
138	Office of Theresia Lee, MD	San Antonio	Texas	United States	78229
139	Progressive Clinical Research	San Antonio	Texas	United States	78229
140	Sendero Imaging and Treatment Center	San Antonio	Texas	United States	78229
141	J. Lewis Research, Inc.	Salt Lake City	Utah	United States	84109
142	J. Lewis Research, Incorporated/Foothill Family Clinic South	Salt Lake City	Utah	United States	84121
143	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911
144	Chesapeake Regional Imaging Center-Kempsville	Norfolk	Virginia	United States	23502
145	Hampton Road Center for Clinical Research	Norfolk	Virginia	United States	23502
146	National Clinical Research - Richmond	Richmond	Virginia	United States	23294
147	Virginia Beach Radiology	Virginia Beach	Virginia	United States	23454-3033
148	Advanced Pain Management	Virginia Beach	Virginia	United States	23454
149	Northwest Clinical Research Center	Bellevue	Washington	United States	98007

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00924664
• Other Study ID Numbers: A4091039; CLBP SAFETY EXTENSION OF 1012
• First Posted: Jun 19, 2009
• Last Update Posted: Apr 21, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Pfizer: low back pain monoclonal antibody nerve growth factor
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Tanezumab

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	322	527
Treated	321	527
COMPLETED	0	0
NOT COMPLETED	322	527

Baseline Characteristics

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	321	527	848
Age, Customized (Count of Participants)
18 to 44 years	79 24.6%	128 24.3%	207 24.4%
45 to 64 years	182 56.7%	300 56.9%	482 56.8%
Greater than (>) 64 years	60 18.7%	99 18.8%	159 18.8%
Sex: Female, Male (Count of Participants)
Female	167 52%	277 52.6%	444 52.4%
Male	154 48%	250 47.4%	404 47.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	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.
Time Frame	Baseline up to 112 days after last dose of study treatment (up to 448 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	527
AEs	198 61.7%	370 70.2%
SAEs	15 4.7%	24 4.6%

2. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	527
Baseline	0.89 (2.53)	1.14 (2.81)
Change at Week 4	0.34 (1.37)	0.54 (2.12)

3. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	295	480
Mean (Standard Deviation) [units on a scale]	0.42 (1.72)	0.54 (1.84)

4. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	270	425
Mean (Standard Deviation) [units on a scale]	0.39 (1.60)	0.42 (1.75)

5. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	226	369
Mean (Standard Deviation) [units on a scale]	0.35 (1.65)	0.46 (1.93)

6. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 32

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	149	241
Mean (Standard Deviation) [units on a scale]	0.36 (1.54)	0.32 (1.47)

7. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 40

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	69	143
Mean (Standard Deviation) [units on a scale]	0.55 (1.69)	0.26 (1.52)

8. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	8	51
Mean (Standard Deviation) [units on a scale]	0.75 (2.19)	0.18 (1.20)

9. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 56

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	0	10
Mean (Standard Deviation) [units on a scale]	0.70 (2.36)

10. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	527
Baseline: Worst Pain	7.09 (1.56)	7.29 (1.53)
Baseline: Least Pain	5.02 (2.09)	4.95 (2.02)
Baseline: Average Pain	6.13 (1.51)	6.25 (1.43)
Baseline: Pain right now	6.22 (2.01)	6.22 (1.93)
Change at Week 4: Worst Pain	-3.68 (2.65)	-3.97 (2.81)
Change at Week 4: Least Pain	-2.88 (2.51)	-2.93 (2.43)
Change at Week 4: Average Pain	-3.22 (2.39)	-3.45 (2.38)
Change at Week 4: Pain right now	-3.70 (2.74)	-3.86 (2.73)

11. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	291	479
Change at Week 8: Worst Pain	-3.20 (2.67)	-3.68 (2.75)
Change at Week 8: Least Pain	-2.65 (2.49)	-2.83 (2.44)
Change at Week 8: Average Pain	-2.92 (2.30)	-3.36 (2.36)
Change at Week 8: Pain right now	-3.27 (2.71)	-3.63 (2.78)

12. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	244	378
Change at Week 16: Worst Pain	-3.30 (2.83)	-3.58 (2.72)
Change at Week 16: Least Pain	-2.75 (2.42)	-2.73 (2.40)
Change at Week 16: Average Pain	-3.00 (2.41)	-3.34 (2.38)
Change at Week 16: Pain right now	-3.42 (2.67)	-3.68 (2.67)

13. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	155	258
Change at Week 24: Worst Pain	-3.45 (2.80)	-3.55 (2.74)
Change at Week 24: Least Pain	-2.79 (2.44)	-2.63 (2.34)
Change at Week 24: Average Pain	-3.14 (2.40)	-3.31 (2.29)
Change at Week 24: Pain right now	-3.50 (2.80)	-3.59 (2.66)

14. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 32

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	68	128
Change at Week 32: Worst Pain	-3.26 (2.90)	-3.80 (2.61)
Change at Week 32: Least Pain	-2.50 (2.88)	-2.68 (2.35)
Change at Week 32: Average Pain	-2.82 (2.63)	-3.23 (2.18)
Change at Week 32: Pain right now	-3.35 (2.96)	-3.77 (2.43)

15. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 40

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	8	37
Change at Week 40: Worst Pain	-3.88 (2.42)	-3.49 (2.67)
Change at Week 40: Least Pain	-2.75 (2.76)	-2.43 (1.91)
Change at Week 40: Average Pain	-2.75 (3.01)	-2.97 (2.28)
Change at Week 40: Pain right now	-3.13 (3.60)	-3.57 (2.44)

16. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	0	7
Change at Week 48: Worst Pain	-2.43 (2.44)
Change at Week 48: Least Pain	-0.86 (1.95)
Change at Week 48: Average Pain	-2.14 (2.12)
Change at Week 48: Pain right now	-2.00 (2.38)

17. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 56

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	0	0

18. Primary Outcome

Title	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
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	525
Baseline: General Activity	5.91 (2.08)	5.87 (2.10)
Baseline: Walking Ability	5.22 (2.50)	5.40 (2.34)
Baseline: Normal Work	5.74 (2.18)	5.94 (2.11)
Baseline: Sleep	5.97 (2.61)	5.86 (2.50)
Baseline: Composite score	5.36 (2.11)	5.37 (1.91)
Change at Week 4: General Activity	-3.39 (2.76)	-3.45 (2.81)
Change at Week 4: Walking Ability	-2.85 (2.88)	-3.15 (2.85)
Change at Week 4: Normal Work	-3.15 (2.71)	-3.49 (2.80)
Change at Week 4: Sleep	-3.53 (3.13)	-3.45 (2.98)
Change at Week 4: Composite score	-3.09 (2.52)	-3.21 (2.45)

19. Primary Outcome

Title	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
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	291	478
Change at Week 8: General Activity	-2.99 (2.65)	-3.36 (2.88)
Change at Week 8: Walking Ability	-2.58 (2.68)	-3.00 (2.89)
Change at Week 8: Normal Work	-2.77 (2.62)	-3.32 (2.90)
Change at Week 8: Sleep	-3.15 (3.06)	-3.34 (2.96)
Change at Week 8: Composite score	-2.74 (2.40)	-3.09 (2.52)

20. Primary Outcome

Title	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
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	244	376
Change at Week 16: General Activity	-3.20 (2.81)	-3.26 (2.89)
Change at Week 16: Walking Ability	-2.55 (2.76)	-2.94 (2.93)
Change at Week 16: Normal Work	-2.83 (2.61)	-3.26 (2.84)
Change at Week 16: Sleep	-3.19 (2.93)	-3.34 (2.94)
Change at Week 16: Composite score	-2.76 (2.44)	-3.05 (2.51)

21. Primary Outcome

Title	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
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	155	256
Change at Week 24: General Activity	-3.12 (2.87)	-3.25 (2.95)
Change at Week 24: Walking Ability	-2.70 (2.84)	-2.90 (2.81)
Change at Week 24: Normal Work	-3.06 (2.80)	-3.25 (2.77)
Change at Week 24: Sleep	-3.47 (2.91)	-3.42 (2.96)
Change at Week 24: Composite score	-2.90 (2.52)	-3.03 (2.50)

22. Primary Outcome

Title	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
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 32

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	68	127
Change at Week 32: General Activity	-2.47 (3.21)	-3.17 (2.67)
Change at Week 32: Walking Ability	-2.32 (3.26)	-2.74 (2.78)
Change at Week 32: Normal Work	-2.74 (3.31)	-3.20 (2.65)
Change at Week 32: Sleep	-3.10 (3.22)	-3.47 (2.91)
Change at Week 32: Composite score	-2.52 (3.09)	-2.94 (2.32)

23. Primary Outcome

Title	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
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 40

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	8	37
Change at Week 40: General Activity	-2.88 (3.04)	-2.46 (2.55)
Change at Week 40: Walking Ability	-2.13 (2.53)	-2.59 (2.73)
Change at Week 40: Normal Work	-2.63 (3.38)	-2.73 (2.36)
Change at Week 40: Sleep	-3.13 (3.72)	-3.41 (2.62)
Change at Week 40: Composite score	-2.27 (3.18)	-2.72 (2.28)

24. Primary Outcome

Title	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
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	0	7
Change at Week 48: General Activity	-1.71 (2.21)
Change at Week 48: Walking Ability	-1.71 (2.21)
Change at Week 48: Normal Work	-1.57 (1.99)
Change at Week 48: Sleep	-2.43 (1.13)
Change at Week 48: Composite score	-1.76 (1.53)

25. Primary Outcome

Title	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 56
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 56

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	0	0

26. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	320	525
Baseline	13.01 (5.13)	12.66 (4.85)
Change at Week 4	-5.52 (5.73)	-5.35 (5.47)

27. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	245	399
Mean (Standard Deviation) [units on a scale]	-4.86 (5.14)	-5.02 (5.71)

28. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	202	310
Mean (Standard Deviation) [units on a scale]	-4.90 (5.84)	-5.19 (5.36)

29. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	126	210
Mean (Standard Deviation) [units on a scale]	-4.79 (5.64)	-5.30 (5.61)

30. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 32

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	59	107
Mean (Standard Deviation) [units on a scale]	-5.36 (5.87)	-5.07 (5.46)

31. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 40

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	8	32
Mean (Standard Deviation) [units on a scale]	-6.00 (6.32)	-4.13 (6.32)

32. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	0	6
Mean (Standard Deviation) [units on a scale]	-2.67 (6.02)

33. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 56

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	0	0

34. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	527
Baseline	3.38 (0.57)	3.36 (0.56)
Change at Week 4	-1.17 (1.00)	-1.21 (1.00)

35. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	291	480
Mean (Standard Deviation) [units on a scale]	-0.97 (0.97)	-1.07 (1.01)

36. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	244	376
Mean (Standard Deviation) [units on a scale]	-1.05 (1.02)	-1.03 (0.96)

37. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	154	258
Mean (Standard Deviation) [units on a scale]	-1.09 (0.95)	-1.05 (1.01)

38. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 32

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	68	128
Mean (Standard Deviation) [units on a scale]	-1.07 (1.14)	-1.05 (0.98)

39. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 40

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	8	37
Mean (Standard Deviation) [units on a scale]	-1.25 (1.04)	-0.95 (1.03)

40. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	0	7
Mean (Standard Deviation) [units on a scale]	-0.43 (0.79)

41. Primary Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56
Description	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).
Time Frame	A4091012: Baseline, A4091039: Week 56

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	0	0

42. Secondary Outcome

Title	Time to Discontinuation Due to Lack of Efficacy
Description	Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Time Frame	Baseline up to Week 56

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	527
Median (Full Range) [days]	NA	NA

43. Secondary Outcome

Title	Plasma Concentration of Tanezumab
Description	Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.
Time Frame	Baseline (Day 1), Week 8, 24, 40, 56, 64

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	268	433
Baseline	393.519 (659.8150)	427.871 (771.2499)
Week 8	596.957 (533.8274)	1074.76 (527.5588)
Week 24	588.216 (296.7509)	1276.75 (770.0278)
Week 40	542.571 (240.5285)	1058.92 (666.4789)
Week 56	250.512 (393.9501)	502.320 (676.1049)

44. Secondary Outcome

Title	Total Nerve Growth Factor (NGF) Concentration
Time Frame	Baseline (Day 1), Week 8, 24, 40, 56, 64

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	270	430
Baseline	2599.9 (1893.7)	2025.4 (2281.4)
Week 8	3771.1 (1472.3)	4470.2 (1773.6)
Week 24	4132.7 (1780.1)	4860.6 (1990.6)
Week 40	4314.0 (1372.4)	4446.7 (1807.1)
Week 56	2855.5 (1651.8)	3639.3 (1990.3)

45. Other Pre-specified Outcome

Title	Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP)
Description	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).
Time Frame	Baseline up to Week 56

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	527
Count of Participants [Participants]	150 46.7%	268 50.9%

46. Other Pre-specified Outcome

Title	Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56
Description	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.
Time Frame	A4091012: Baseline, A4091039: Week 24, 56

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	527
Baseline:activity impairment	58.19 (23.05)	58.74 (21.24)
Baseline:impairment during work	48.77 (23.56)	47.98 (23.66)
Baseline:overall impairment	8.23 (23.11)	7.46 (21.97)
Baseline:work time missed	2.99 (10.81)	2.27 (8.67)
Change at Week 24:activity impairment	-25.29 (27.64)	-26.34 (28.55)
Change at Week 24:impairment during work	-26.30 (24.79)	-21.36 (26.84)
Change at Week 24:overall impairment	-4.63 (23.62)	-3.25 (21.39)
Change at Week 24:work time missed	-1.49 (10.33)	-0.50 (8.24)
Change at Week 56:activity impairment	-8.00 (34.58)
Change at Week 56:impairment during work	-10.00 (28.28)
Change at Week 56:overall impairment	1.75 (16.76)
Change at Week 56:work time missed	1.41 (4.71)

47. Other Pre-specified Outcome

Title	Number of Participants Who Developed Anti-Tanezumab Antibodies
Description	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.
Time Frame	Baseline (Day 1), Week 8, 24, 40, 56, 64

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	269	435
Baseline	1 0.3%	0 0%
Week 8	4 1.2%	1 0.2%
Week 24	3 0.9%	1 0.2%
Week 40	0 0%	0 0%
Week 56	1 0.3%	1 0.2%

48. Other Pre-specified Outcome

Title	Number of Participants With Injection and Infusion Site Reactions
Description	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.
Time Frame	Baseline (Day 1), Week 4, 8, 16, 24, 32 for intravenous infusion; Week 24, 32, 40, 56, 64 for subcutaneous injection

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	527
Baseline: Infusion site	7 2.2%	7 1.3%
Week 4: Infusion site	0 0%	0 0%
Week 8: Infusion site	5 1.6%	5 0.9%
Week 16: Infusion site	4 1.2%	5 0.9%
Week 24: Infusion site	0 0%	0 0%
Week 32: Infusion site	0 0%	0 0%
Week 24: Injection site	2 0.6%	4 0.8%
Week 32: Injection site	0 0%	2 0.4%
Week 40: Injection site	0 0%	0 0%
Week 56: Injection site	0 0%	0 0%

49. Other Pre-specified Outcome

Title	Number of Participants With Intravenous and Subcutaneous Doses of Study Medication
Description	Number of participants are reported based on the maximum number of intravenous (IV) and subcutaneous (SC) doses of tanezumab received.
Time Frame	Day 1 up to Week 56

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab 10 mg	Tanezumab 20 mg
Arm/Group Description	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.	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.
Measure Participants	321	527
Number of IV Doses: 1	59 18.4%	102 19.4%
Number of IV Doses: 2	93 29%	145 27.5%
Number of IV Doses: 3	169 52.6%	276 52.4%
Number of IV Doses: 4	0 0%	3 0.6%
Number of IV Doses: 5	0 0%	1 0.2%
Number of SC Doses: 1	71 22.1%	111 21.1%
Number of SC Doses: 2	8 2.5%	42 8%
Number of SC Doses: 3	1 0.3%	7 1.3%

Adverse Events

Adverse Event Reporting Description	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
Arm/Group Title	Tanezumab 10 mg		Tanezumab 20 mg
Arm/Group Description	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.		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.
All Cause Mortality
	Tanezumab 10 mg		Tanezumab 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tanezumab 10 mg		Tanezumab 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/321 (4.7%)		24/527 (4.6%)
Cardiac disorders
Acute myocardial infarction	0/321 (0%)		1/527 (0.2%)
Cardiac arrest	0/321 (0%)		1/527 (0.2%)
Coronary artery disease	0/321 (0%)		2/527 (0.4%)
Congenital, familial and genetic disorders
Arnold-Chiari malformation	1/321 (0.3%)		0/527 (0%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	0/321 (0%)		1/527 (0.2%)
Hiatus hernia	0/321 (0%)		1/527 (0.2%)
Large intestine perforation	0/321 (0%)		1/527 (0.2%)
General disorders
Chest pain	0/321 (0%)		1/527 (0.2%)
Death	0/321 (0%)		1/527 (0.2%)
Hepatobiliary disorders
Bile duct stone	1/321 (0.3%)		0/527 (0%)
Infections and infestations
Bronchitis	0/321 (0%)		1/527 (0.2%)
Diverticulitis	0/321 (0%)		1/527 (0.2%)
Gastroenteritis viral	1/321 (0.3%)		0/527 (0%)
Meningitis	1/321 (0.3%)		0/527 (0%)
Pneumonia	1/321 (0.3%)		0/527 (0%)
Injury, poisoning and procedural complications
Ankle fracture	1/321 (0.3%)		0/527 (0%)
Femur fracture	1/321 (0.3%)		0/527 (0%)
Hip fracture	0/321 (0%)		1/527 (0.2%)
Patella fracture	1/321 (0.3%)		0/527 (0%)
Tendon injury	1/321 (0.3%)		0/527 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/321 (0%)		1/527 (0.2%)
Intervertebral disc degeneration	0/321 (0%)		1/527 (0.2%)
Intervertebral disc protrusion	0/321 (0%)		2/527 (0.4%)
Joint swelling	0/321 (0%)		1/527 (0.2%)
Muscular weakness	1/321 (0.3%)		0/527 (0%)
Musculoskeletal pain	0/321 (0%)		1/527 (0.2%)
Osteoarthritis	3/321 (0.9%)		3/527 (0.6%)
Osteonecrosis	2/321 (0.6%)		4/527 (0.8%)
Pain in extremity	0/321 (0%)		1/527 (0.2%)
Spinal column stenosis	1/321 (0.3%)		0/527 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	0/321 (0%)		1/527 (0.2%)
Liposarcoma	1/321 (0.3%)		0/527 (0%)
Lung neoplasm malignant	0/321 (0%)		2/527 (0.4%)
Multiple myeloma	0/321 (0%)		1/527 (0.2%)
Nervous system disorders
Syncope	0/321 (0%)		1/527 (0.2%)
Psychiatric disorders
Anxiety	0/321 (0%)		1/527 (0.2%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/321 (0%)		1/527 (0.2%)
Vascular disorders
Aortic stenosis	1/321 (0.3%)		0/527 (0%)
Lymphoedema	0/321 (0%)		1/527 (0.2%)
Other (Not Including Serious) Adverse Events
	Tanezumab 10 mg		Tanezumab 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	152/321 (47.4%)		277/527 (52.6%)
Gastrointestinal disorders
Diarrhoea	6/321 (1.9%)		18/527 (3.4%)
General disorders
Infusion site reaction	12/321 (3.7%)		17/527 (3.2%)
Oedema peripheral	11/321 (3.4%)		32/527 (6.1%)
Infections and infestations
Nasopharyngitis	5/321 (1.6%)		13/527 (2.5%)
Sinusitis	12/321 (3.7%)		14/527 (2.7%)
Upper respiratory tract infection	11/321 (3.4%)		26/527 (4.9%)
Urinary tract infection	9/321 (2.8%)		13/527 (2.5%)
Injury, poisoning and procedural complications
Fall	7/321 (2.2%)		15/527 (2.8%)
Muscle strain	8/321 (2.5%)		17/527 (3.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	41/321 (12.8%)		76/527 (14.4%)
Back pain	10/321 (3.1%)		17/527 (3.2%)
Joint swelling	6/321 (1.9%)		16/527 (3%)
Muscle spasms	7/321 (2.2%)		15/527 (2.8%)
Musculoskeletal pain	14/321 (4.4%)		22/527 (4.2%)
Myalgia	6/321 (1.9%)		18/527 (3.4%)
Osteoarthritis	9/321 (2.8%)		14/527 (2.7%)
Pain in extremity	12/321 (3.7%)		38/527 (7.2%)
Nervous system disorders
Allodynia	0/321 (0%)		11/527 (2.1%)
Decreased vibratory sense	2/321 (0.6%)		14/527 (2.7%)
Headache	10/321 (3.1%)		27/527 (5.1%)
Hyperaesthesia	3/321 (0.9%)		11/527 (2.1%)
Hypoaesthesia	23/321 (7.2%)		41/527 (7.8%)
Paraesthesia	31/321 (9.7%)		56/527 (10.6%)
Skin and subcutaneous tissue disorders
Rash	2/321 (0.6%)		11/527 (2.1%)

Limitations/Caveats

Due to FDA-imposed clinical hold, further study drug dosing stopped prematurely and study was terminated. Designation of outcomes as primary, secondary based on study team input as study did not specify them as primary or secondary.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.