Tanezumab in Osteoarthritis of the Hip or Knee (2)

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00863304
• Collaborator: (none)
• Enrollment: 849
• Locations: 95
• Arms: 4
• Actual Duration (Months): 14.2
• Patients Per Site: 8.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Biological: tanezumab 10 mg; Biological: tanezumab 5 mg; Drug: naproxen; Other: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 849 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
• Actual Study Start Date: Jun 9, 2009
• Actual Primary Completion Date: Apr 27, 2010
• Actual Study Completion Date: Aug 16, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: tanezumab 10 mg; tanezumab 10 mg one dose at weeks 0 and 8
Experimental: 2	Biological: tanezumab 5 mg; tanezumab 5 mg one dose at weeks 0 and 8
Active Comparator: 3	Drug: naproxen; naproxen 1000 mg daily for 16 weeks
Placebo Comparator: 4	Other: placebo; placebo to match tanezumab and naproxen dosing

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) [Baseline, Week 16]

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

2. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF) [Baseline, Week 16]

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.

3. Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) [Baseline, Week 16]

   PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.

Secondary Outcome Measures

1. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, and 12]

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

2. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, and 16]

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

3. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, and 12]

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.

4. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, and 16]

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.

5. Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, and 12]

   Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.

6. Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, and 16]

   Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.

7. Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) [Weeks 2, 4, 8, 12, and 16]

   Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.

8. Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) [Weeks 2, 4, 8, 12, and 16]

   Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.

9. Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) [Weeks 2, 4, 8, 12, and 16]

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.

10. Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) [Weeks 2, 4, 8, 12, and 16]

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.

11. Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) [Weeks 2, 4, 8, 12, and 16]

    PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.

12. Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) [Weeks 2, 4, 8, 12, and 16]

    PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.

13. Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) [Baseline up to Week 16]

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

14. Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) [Baseline up to Week 16]

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0%; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

15. Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, and 16]

    Participants assessed their average daily pain score in the index hip/knee using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. A weekly mean was calculated using the daily index hip/knee pain scores within each specified study week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.

16. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, and 16]

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness.

17. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, and 16]

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [worst stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no difficulty) to 10 (maximum difficulty), where higher scores indicated worse response.

18. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, and 16]

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

19. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, and 16]

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

20. Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 12, and 16]

    The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum), where higher score indicated a better health related quality of life.

21. Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 12, and 16]

    The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.

22. Time to Discontinuation Due to Lack of Efficacy [Baseline up to Week 16]

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

23. Percentage of Participants Who Used Rescue Medication [Weeks 2, 4, 8, 12, and 16]

    In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized.

24. Duration of Rescue Medication Use [Weeks 2, 4, 8, 12, and 16]

    In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized.

25. Amount of Rescue Medication Taken [Weeks 2, 4, 8, 12, and 16]

    In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.

26. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline (Day 1) up to Week 24]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

27. Number of Participants With Laboratory Test Abnormalities [Baseline (Day 1) up to Week 24]

    Laboratory values: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3*ULN), electrolytes (sodium<0.95* LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1).

28. Number of Participants With Abnormal Electrocardiogram (ECG) Findings [Baseline (Day 1) up to Week 24]

    All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as treatment related adverse events were presented. Relatedness to treatment was assessed by investigator.

29. Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24 [Baseline, Weeks 2, 4, 8, 12, 16, and 24]

    NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 122 (maximum impairment), higher scores indicated increased impairment.

30. Number of Participants With Positive Anti-Drug Antibody (ADA) Level [Baseline, Weeks 8, 16, and 24]

    Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: Tanezumab 5 mg + Placebo and Tanezumab 10 mg + Placebo. Results with titer value >= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive.

31. Number of Participants With Abnormal Physical Examinations Findings [Baseline (Day 1)]

    Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others. Criteria for abnormal physical findings were based on investigator's discretion.

32. Number of Participants With Adverse Events Associated With Vital Sign Measurements [Baseline (Day 1) up to Week 24]

    Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant vital signs (based on the investigator's judgment) considered as adverse events were reported.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

• pregnancy or intent to become pregnant

• BMI greater than 39

• other severe pain, significant cardiac, neurological or psychiatric disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Greystone Medical Research, LLC	Birmingham	Alabama	United States	35242
2	Saadat Ansari, MD	Huntsville	Alabama	United States	35801
3	Coastal Clinical Research, Inc.	Mobile	Alabama	United States	36608
4	Clinical Research Advantage, Inc. / Central Arizona Medical Associates, PC	Mesa	Arizona	United States	85206
5	Novara Clinical Research	Mesa	Arizona	United States	85206
6	Clinical Research Advantage, Inc.	Mesa	Arizona	United States	85213
7	Central Phoenix Medical - Clinical Research Advantage	Phoenix	Arizona	United States	85020
8	Paradigm Clinical, Inc	Tucson	Arizona	United States	85705
9	eStudySite	Chula Vista	California	United States	91911
10	Orthopedic Physicians of Colorado, PC	Englewood	California	United States	80113
11	University Parks Hematology/Oncology	Englewood	California	United States	80113
12	Edinger Medical Group and Research Center	Fountain Valley	California	United States	92708
13	Valley Research	Fresno	California	United States	93720
14	Lakewood Orthopedic Medical & Surgical Group	Lakewood	California	United States	90712
15	High Desert Medical Group Research for Life	Lancaster	California	United States	93534
16	Premiere Clinical Research, LLC	Long Beach	California	United States	90807
17	Miracle Mile Medical Center	Los Angeles	California	United States	90036
18	Samaritan Center for Medical Research	Los Gatos	California	United States	95032
19	Del Carmen Medical Center	Reseda	California	United States	91335
20	Probe Clinical Research, Corp.	Santa Ana	California	United States	92701
21	Lawrence P.McAdam, MD, A Medical Corporation	Thousand Oaks	California	United States	91360
22	Westlake Medical Center	Westlake Village	California	United States	91361
23	Peak Anesthesia and Pain Management	Centennial	Colorado	United States	80112
24	Denver Internal Medicine Group	Denver	Colorado	United States	80209
25	Mountain View Clinical Research, Inc.	Denver	Colorado	United States	80209
26	Colorado Hematology	Englewood	Colorado	United States	80110
27	Colorado Orthopedic Consultants, PC	Englewood	Colorado	United States	80110
28	American Clinical Research, LLC	Englewood	Colorado	United States	80113
29	Norwalk Medical Group	Norwalk	Connecticut	United States	06851
30	Rheumatology Consultants of Delaware	Lewes	Delaware	United States	19958
31	HeartCare	Bradenton	Florida	United States	34202
32	In Vivo Clinical Research, Inc	Doral	Florida	United States	33166
33	S & W Clinical Research	Fort Lauderdale	Florida	United States	33306
34	Centre for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida	United States	33334
35	Kendall South Medical Center, Inc	Miami	Florida	United States	33175
36	Sunshine Research Center	Opa-locka	Florida	United States	33054
37	Rheumatology Associates of Central Florida, PA	Orlando	Florida	United States	32806
38	HeartCare Research	Sarasota	Florida	United States	34232
39	Tampa Medical Group PA	Tampa	Florida	United States	33614
40	Masters of Clinical Research, Inc.	Augusta	Georgia	United States	30909
41	River Birch Research Alliance, LLC	Blue Ridge	Georgia	United States	30513
42	Millennium Pain Center	Bloomington	Illinois	United States	61701
43	Rehabilitation Institute of Chicago	Chicago	Illinois	United States	60611
44	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
45	Pasadena Pharmacy	Lexington	Kentucky	United States	40503
46	The Pain Treatment Center of the Bluegrass	Lexington	Kentucky	United States	40503
47	L-Marc Research Center	Louisville	Kentucky	United States	40213
48	Bone and Joint Clinic of Baton Rouge	Baton Rouge	Louisiana	United States	70808
49	Gulf Coast Research, LLC	Baton Rouge	Louisiana	United States	70808
50	Mid-Atlantic Medical Research Centers	Hollywood	Maryland	United States	20636
51	Beacon Clinical Research, LLC	Brockton	Massachusetts	United States	02301
52	Miray Medical Center	Brockton	Massachusetts	United States	02301
53	Great Lakes Research Group, Incorporated	Bay City	Michigan	United States	48706
54	Planters Clinic	Port Gibson	Mississippi	United States	39150
55	Medex Healthcare Research, Inc.	Saint Louis	Missouri	United States	63117
56	St. John's Medical Research Institute, Inc.	Springfield	Missouri	United States	65807
57	Diagnositc Center of Medicine	Henderson	Nevada	United States	89052
58	Independent Clinical Researchers	Las Vegas	Nevada	United States	89103
59	Wolfson Medical Center	Las Vegas	Nevada	United States	89103
60	Clinical Research Consortium	Las Vegas	Nevada	United States	89119
61	SPRI Bronx LLC	Bronx	New York	United States	10454
62	Medex Healthcare Research, Inc.	New York	New York	United States	10004
63	Columbus Clinical Research, Inc.	Columbus	Ohio	United States	43213
64	Providence Health Partners - Center for Clinical Research	Dayton	Ohio	United States	45439
65	Orthopedic & Sports Medicine Consultants	Middletown	Ohio	United States	45042
66	Signal Point Clinical Research Center, LLC	Middletown	Ohio	United States	45042
67	Physicians' Research, Inc	Zanesville	Ohio	United States	43701
68	PrimeCare of Southeastern Ohio, Inc	Zanesville	Ohio	United States	43701
69	Cor Clinical Research, LLC	Oklahoma City	Oklahoma	United States	73103
70	The Family Healthcare Center, PA	Clinton	South Carolina	United States	29325
71	Southern Orthopaedic Sports Medicine	Columbia	South Carolina	United States	29204
72	Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
73	Low Country Rheumatology, PA	North Charleston	South Carolina	United States	29406
74	The Carolina Center for Rheumatology and Arthritis Care, PA	Rock Hill	South Carolina	United States	29732
75	Palmetto Clinical Trial Services, LLC	Simpsonville	South Carolina	United States	29681
76	South Austin Orthopedics	Austin	Texas	United States	78745
77	Tekton Research Inc. - Research Office	Austin	Texas	United States	78746
78	Texas Orthopedic Specialists	Grapevine	Texas	United States	76051
79	Foundation for Southwest Orthopedic Research	Houston	Texas	United States	77030
80	Southwest Orthopedic Group	Houston	Texas	United States	77030
81	The Neurology Center	Houston	Texas	United States	77030
82	Gill Orthopedic Center	Lubbock	Texas	United States	79410
83	Robert R. King, M.D., PA	Lubbock	Texas	United States	79410
84	AZ Clinical Research	Sugar Land	Texas	United States	77478
85	Spring Clinical Research	Sugar Land	Texas	United States	77478
86	Sugar Land Med-Ped, P.A.	Sugar Land	Texas	United States	77479
87	Grayline Clinical Drug Trials	Wichita Falls	Texas	United States	76309
88	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah	United States	84109
89	J. Lewis Research, Incorporated/Foothill Family Clinic South	Salt Lake City	Utah	United States	84121
90	Commonwealth Orthopedics & Rehabilitation , P.C.	Arlington	Virginia	United States	22205
91	IntegraTrials, LLC	Arlington	Virginia	United States	22205
92	Virginia Hospital Center	Arlington	Virginia	United States	22205
93	HypotheTest, LLC	Roanoke	Virginia	United States	24018
94	Empirical Clinical Trials, LLC	Selah	Washington	United States	98942
95	Arthritis Northwest, PLLC	Spokane	Washington	United States	99204-2336

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: NCT00863304
• Other Study ID Numbers: A4091018
• First Posted: Mar 17, 2009
• Last Update Posted: May 17, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Pfizer: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Naproxen; Tanezumab

Study Results

Participant Flow

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Period Title: Overall Study
STARTED	212	212	213	212
Treated	209	211	209	211
COMPLETED	18	27	26	21
NOT COMPLETED	194	185	187	191

Baseline Characteristics

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo	Total
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.	Total of all reporting groups
Overall Participants	209	211	209	211	840
Age, Customized (Count of Participants)
18 to 44 years	6 2.9%	13 6.2%	14 6.7%	14 6.6%	47 5.6%
45 to 64 years	133 63.6%	133 63%	134 64.1%	126 59.7%	526 62.6%
Greater than or equal to (>=) 65 years	70 33.5%	65 30.8%	61 29.2%	71 33.6%	267 31.8%
Sex: Female, Male (Count of Participants)
Female	136 65.1%	134 63.5%	128 61.2%	136 64.5%	534 63.6%
Male	73 34.9%	77 36.5%	81 38.8%	75 35.5%	306 36.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Baseline	7.41 (1.38)	7.27 (1.38)	7.37 (1.39)	7.30 (1.41)
Change at week 16	-2.14 (2.74)	-3.32 (2.77)	-3.03 (3.05)	-2.61 (2.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Square (LS) Mean Difference
	Estimated Value	-1.13
	Confidence Interval	(2-Sided) 95%; -1.65 to -0.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.80
	Confidence Interval	(2-Sided) 95%; -1.32 to -0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.090
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -0.96 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.69
	Confidence Interval	(2-Sided) 95%; -1.21 to -0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.175
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -0.87 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

2. Primary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Baseline	7.04 (1.49)	6.83 (1.56)	7.09 (1.52)	6.95 (1.64)
Change at Week 16	-1.75 (2.53)	-3.01 (2.64)	-2.86 (2.98)	-2.25 (2.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.23
	Confidence Interval	(2-Sided) 95%; -1.71 to -0.75
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.99
	Confidence Interval	(2-Sided) 95%; -1.48 to -0.51
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.067
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.46
	Confidence Interval	(2-Sided) 95%; -0.94 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.77
	Confidence Interval	(2-Sided) 95%; -1.26 to -0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.031
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.54
	Confidence Interval	(2-Sided) 95%; -1.03 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

3. Primary Outcome

Title	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
Description	PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Baseline	3.46 (0.65)	3.36 (0.56)	3.40 (0.61)	3.48 (0.61)
Change at Week 16	-0.49 (0.80)	-0.80 (0.89)	-0.80 (1.00)	-0.66 (0.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -0.50 to -0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.48 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.078
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -0.30 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.35 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.029
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.34 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Change at Week 2	-2.11 (2.15)	-2.64 (2.48)	-2.42 (2.64)	-2.92 (2.42)
Change at Week 4	-2.29 (2.38)	-3.48 (2.55)	-3.27 (2.82)	-2.98 (2.33)
Change at Week 8	-2.23 (2.46)	-3.46 (2.65)	-3.06 (2.81)	-2.85 (2.39)
Change at Week 12	-2.12 (2.69)	-3.40 (2.76)	-3.24 (3.02)	-2.78 (2.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.029
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -0.94 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.214
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.28
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.76
	Confidence Interval	(2-Sided) 95%; -1.21 to -0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.234
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.27
	Confidence Interval	(2-Sided) 95%; -0.18 to 0.72
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.034
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.93
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.16
	Confidence Interval	(2-Sided) 95%; -1.63 to -0.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.96
	Confidence Interval	(2-Sided) 95%; -1.42 to -0.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95%; -1.11 to -0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.029
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95%; -0.99 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.193
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95%; -0.78 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.20
	Confidence Interval	(2-Sided) 95%; -1.68 to -0.73
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.80
	Confidence Interval	(2-Sided) 95%; -1.28 to -0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -1.10 to -0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.58
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.464
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.66 to 0.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.22
	Confidence Interval	(2-Sided) 95%; -1.72 to -0.72
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.04
	Confidence Interval	(2-Sided) 95%; -1.55 to -0.54
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.63
	Confidence Interval	(2-Sided) 95%; -1.14 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.023
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -1.09 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.114
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.92 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Baseline	7.41 (1.38)	7.27 (1.38)	7.37 (1.39)	7.30 (1.41)
Change at Week 2	-2.11 (2.15)	-2.64 (2.48)	-2.42 (2.64)	-2.92 (2.42)
Change at Week 4	-2.42 (2.36)	-3.57 (2.49)	-3.35 (2.79)	-3.04 (2.35)
Change at Week 8	-2.48 (2.39)	-3.59 (2.57)	-3.39 (2.75)	-3.05 (2.39)
Change at Week 12	-2.58 (2.63)	-3.79 (2.58)	-3.73 (2.84)	-3.12 (2.56)
Change at Week 16	-2.64 (2.67)	-3.80 (2.58)	-3.58 (2.87)	-3.07 (2.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.029
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -0.94 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.214
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.28
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.76
	Confidence Interval	(2-Sided) 95%; -1.21 to -0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.234
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.27
	Confidence Interval	(2-Sided) 95%; -0.18 to 0.72
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.034
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.93
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.13
	Confidence Interval	(2-Sided) 95%; -1.59 to -0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.91
	Confidence Interval	(2-Sided) 95%; -1.37 to -0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -1.05 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.023
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.54
	Confidence Interval	(2-Sided) 95%; -1.00 to -0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.175
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.78 to 0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.09
	Confidence Interval	(2-Sided) 95%; -1.55 to -0.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.88
	Confidence Interval	(2-Sided) 95%; -1.34 to -0.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95%; -1.03 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95%; -0.99 to -0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.190
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95%; -0.78 to 0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.15
	Confidence Interval	(2-Sided) 95%; -1.63 to -0.68
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.07
	Confidence Interval	(2-Sided) 95%; -1.55 to -0.60
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.034
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95%; -0.99 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 9%; -1.12 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.023
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95%; -1.04 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.12
	Confidence Interval	(2-Sided) 95%; -1.60 to -0.64
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.87
	Confidence Interval	(2-Sided) 95%; -1.35 to -0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.092
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.90 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95%; -1.19 to -0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.064
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.46
	Confidence Interval	(2-Sided) 95%; -0.94 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Baseline	7.04 (1.49)	6.83 (1.56)	7.09 (1.52)	6.95 (1.64)
Change at Week 2	-1.60 (2.12)	-2.34 (2.37)	-2.33 (2.50)	-2.52 (2.40)
Change at Week 4	-1.77 (2.24)	-3.04 (2.50)	-2.94 (2.80)	-2.55 (2.36)
Change at Week 8	-1.76 (2.31)	-3.00 (2.61)	-2.83 (2.79)	-2.40 (2.29)
Change at Week 12	-1.71 (2.49)	-3.06 (2.66)	-2.95 (2.95)	-2.47 (2.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.12 to -0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.66
	Confidence Interval	(2-Sided) 95%; -1.09 to -0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.82
	Confidence Interval	(2-Sided) 95%; -1.25 to -0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.572
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -0.31 to 0.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.467
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 95%; -0.27 to 0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.28
	Confidence Interval	(2-Sided) 95%; -1.74 to -0.83
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.12
	Confidence Interval	(2-Sided) 95%; -1.58 to -0.66
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.73
	Confidence Interval	(2-Sided) 95%; -1.19 to -0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.55
	Confidence Interval	(2-Sided) 95%; -1.01 to -0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.101
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -0.85 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.24
	Confidence Interval	(2-Sided) 95%; -1.70 to -0.78
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.00
	Confidence Interval	(2-Sided) 95%; -1.47 to -0.54
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -1.08 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -1.08 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.101
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -0.85 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.31
	Confidence Interval	(2-Sided) 95%; -1.79 to -0.83
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.15
	Confidence Interval	(2-Sided) 95%; -1.63 to -0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.72
	Confidence Interval	(2-Sided) 95%; -1.21 to -0.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.016
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -1.08 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.082
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.91 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Change at Week 2	-1.60 (2.12)	-2.34 (2.37)	-2.33 (2.50)	-2.52 (2.40)
Change at Week 4	-1.84 (2.25)	-3.09 (2.49)	-3.05 (2.78)	-2.58 (2.37)
Change at Week 8	-1.92 (2.29)	-3.13 (2.57)	-3.10 (2.76)	-2.56 (2.34)
Change at Week 12	-2.03 (2.52)	-3.36 (2.58)	-3.36 (2.85)	-2.70 (2.49)
Change at Week 16	-2.08 (2.55)	-3.38 (2.57)	-3.30 (2.87)	-2.60 (2.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.12 to -0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.66
	Confidence Interval	(2-Sided) 95%; -1.09 to -0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.82
	Confidence Interval	(2-Sided) 95%; -1.25 to -0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.572
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -0.31 to 0.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.467
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 95%; -0.27 to 0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.27
	Confidence Interval	(2-Sided) 95%; -1.73 to -0.82
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.15
	Confidence Interval	(2-Sided) 95%; -1.61 to -0.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.16 to -0.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95%; -1.03 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.053
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -0.91 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.21
	Confidence Interval	(2-Sided) 95%; -1.66 to -0.75
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.11
	Confidence Interval	(2-Sided) 95%; -1.56 to -0.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.61
	Confidence Interval	(2-Sided) 95%; -1.07 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -1.05 to -0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.035
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -0.95 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.32
	Confidence Interval	(2-Sided) 95%; -1.79 to -0.85
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.24
	Confidence Interval	(2-Sided) 95%; -1.71 to -0.76
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95%; -1.11 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.68
	Confidence Interval	(2-Sided) 95%; -1.16 to -0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.013
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.60
	Confidence Interval	(2-Sided) 95%; -1.07 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.29
	Confidence Interval	(2-Sided) 95%; -1.76 to -0.81
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.11
	Confidence Interval	(2-Sided) 95%; -1.58 to -0.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.050
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95%; -0.95 to -0.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.81
	Confidence Interval	(2-Sided) 95%; -1.29 to -0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.63
	Confidence Interval	(2-Sided) 95%; -1.11 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Description	Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Change at Week 2	-0.52 (0.87)	-0.65 (0.90)	-0.60 (0.99)	-0.88 (0.85)
Change at Week 4	-0.55 (0.84)	-0.90 (0.98)	-0.93 (1.03)	-0.85 (0.83)
Change at Week 8	-0.51 (0.84)	-0.91 (0.91)	-0.85 (1.01)	-0.71 (0.86)
Change at Week 12	-0.55 (0.85)	-0.85 (0.93)	-0.80 (0.93)	-0.65 (0.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.35 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.113
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 95%; -0.28 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -0.49 to -0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.076
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; 0.06 to 0.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95%; -0.56 to -0.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) 95%; -0.58 to -0.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 95%; -0.43 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.102
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.29 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.066
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.31 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.44
	Confidence Interval	(2-Sided) 95%; -0.60 to -0.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 95%; -0.53 to -0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.34 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.26
	Confidence Interval	(2-Sided) 95%; -0.42 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.35 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95%; -0.49 to -0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 95%; -0.43 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.328
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95%; -0.24 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -0.41 to -0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.022
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.35 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Description	Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Change at Week 2	-0.52 (0.87)	-0.65 (0.90)	-0.60 (0.99)	-0.88 (0.85)
Change at Week 4	-0.55 (0.88)	-0.91 (0.99)	-0.92 (1.05)	-0.86 (0.85)
Change at Week 8	-0.52 (0.90)	-0.92 (0.92)	-0.88 (1.06)	-0.78 (0.87)
Change at Week 12	-0.59 (0.94)	-0.95 (0.95)	-0.88 (1.00)	-0.78 (0.86)
Change at Week 16	-0.55 (0.91)	-0.90 (0.92)	-0.89 (1.06)	-0.79 (0.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.35 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.113
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 95%; -0.28 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -0.49 to -0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.076
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; 0.06 to 0.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.57 to -0.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.57 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.45 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.120
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.29 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.126
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.29 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.46
	Confidence Interval	(2-Sided) 95%; -0.62 to -0.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.57 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -0.41 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.38 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.052
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -0.32 to 0.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.57 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95%; -0.48 to -0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.051
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -0.33 to 0.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -0.41 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.069
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.32 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.57 to -0.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 95%; -0.53 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.37 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.36 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.064
	Comments	P-value was based on pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -0.32 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

10. Secondary Outcome

Title	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Week 2	49.8 23.8%	59.7 28.3%	55.3 26.5%	68.6 32.5%
Week 4	45.9 22%	72.5 34.4%	63.9 30.6%	67.1 31.8%
Week 8	46.9 22.4%	72.0 34.1%	60.6 29%	64.3 30.5%
Week 12	42.6 20.4%	64.5 30.6%	59.6 28.5%	58.9 27.9%
Week 16	42.6 20.4%	64.9 30.8%	55.8 26.7%	53.1 25.2%

11. Secondary Outcome

Title	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Description	Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Week 2	49.8 23.8%	59.7 28.3%	55.3 26.5%	68.6 32.5%
Week 4	48.8 23.3%	74.4 35.3%	65.9 31.5%	69.6 33%
Week 8	53.1 25.4%	74.9 35.5%	66.8 32%	69.6 33%
Week 12	53.6 25.6%	73.5 34.8%	69.7 33.3%	68.1 32.3%
Week 16	55.0 26.3%	74.9 35.5%	68.8 32.9%	64.3 30.5%

12. Secondary Outcome

Title	Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Week 2: >=30 percent reduction	43.1 20.6%	50.2 23.8%	45.2 21.6%	56.5 26.8%
Week 2: >=50 percent reduction	26.3 12.6%	37.0 17.5%	28.4 13.6%	37.2 17.6%
Week 4: >=30 percent reduction	46.4 22.2%	68.7 32.6%	58.2 27.8%	57.0 27%
Week 4: >=50 percent reduction	34.0 16.3%	51.7 24.5%	44.2 21.1%	39.1 18.5%
Week 8: >=30 percent reduction	39.7 19%	68.2 32.3%	54.8 26.2%	57.5 27.3%
Week 8: >=50 percent reduction	32.1 15.4%	54.0 25.6%	42.8 20.5%	41.1 19.5%
Week 12: >=30 percent reduction	40.2 19.2%	64.0 30.3%	56.3 26.9%	52.7 25%
Week 12: >=50 percent reduction	32.1 15.4%	53.1 25.2%	48.6 23.3%	41.5 19.7%
Week 16: >=30 percent reduction	39.2 18.8%	62.1 29.4%	52.9 25.3%	51.7 24.5%
Week 16: >=50 percent reduction	29.7 14.2%	51.7 24.5%	44.7 21.4%	41.1 19.5%

13. Secondary Outcome

Title	Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Week 2: >=30 percent reduction	43.1 20.6%	50.2 23.8%	45.2 21.6%	56.5 26.8%
Week 2: >=50 percent reduction	26.3 12.6%	37.0 17.5%	28.4 13.6%	37.2 17.6%
Week 4: >=30 percent reduction	49.3 23.6%	70.1 33.2%	59.6 28.5%	58.5 27.7%
Week 4: >=50 percent reduction	35.9 17.2%	53.1 25.2%	45.2 21.6%	40.6 19.2%
Week 8: >=30 percent reduction	45.5 21.8%	70.6 33.5%	61.5 29.4%	60.9 28.9%
Week 8: >=50 percent reduction	35.9 17.2%	56.4 26.7%	47.1 22.5%	44.4 21%
Week 12: >=30 percent reduction	48.8 23.3%	71.6 33.9%	65.9 31.5%	58.0 27.5%
Week 12: >=50 percent reduction	37.8 18.1%	58.3 27.6%	53.8 25.7%	45.9 21.8%
Week 16:>=30 percent reduction	48.8 23.3%	71.1 33.7%	64.4 30.8%	58.9 27.9%
Week 16:>=50 percent reduction	35.4 16.9%	58.8 27.9%	51.0 24.4%	46.9 22.2%

14. Secondary Outcome

Title	Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Week 2	13.4 6.4%	14.7 7%	16.8 8%	23.2 11%
Week 4	12.4 5.9%	24.2 11.5%	26.4 12.6%	21.7 10.3%
Week 8	12.4 5.9%	26.5 12.6%	26.9 12.9%	15.5 7.3%
Week 12	12.9 6.2%	23.2 11%	22.1 10.6%	15.0 7.1%
Week 16	12.4 5.9%	21.8 10.3%	22.6 10.8%	19.3 9.1%

15. Secondary Outcome

Title	Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Description	PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Week 2	13.4 6.4%	14.7 7%	16.8 8%	23.2 11%
Week 4	12.9 6.2%	24.6 11.7%	26.9 12.9%	22.2 10.5%
Week 8	12.4 5.9%	27.0 12.8%	28.8 13.8%	17.4 8.2%
Week 12	13.9 6.7%	25.6 12.1%	25.5 12.2%	17.9 8.5%
Week 16	13.4 6.4%	24.6 11.7%	26.0 12.4%	21.3 10.1%

16. Secondary Outcome

Title	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
>0% reduction	54.1 25.9%	71.6 33.9%	64.9 31.1%	67.1 31.8%
>=10% reduction	51.2 24.5%	69.7 33%	61.5 29.4%	61.4 29.1%
>=20% reduction	44.5 21.3%	66.4 31.5%	57.2 27.4%	55.1 26.1%
>=30% reduction	39.2 18.8%	62.1 29.4%	52.9 25.3%	51.7 24.5%
>=40% reduction	33.5 16%	56.9 27%	47.6 22.8%	43.5 20.6%
>=50% reduction	29.7 14.2%	51.7 24.5%	44.7 21.4%	41.1 19.5%
>=60% reduction	26.8 12.8%	44.5 21.1%	38.9 18.6%	32.9 15.6%
>=70% reduction	19.6 9.4%	38.9 18.4%	29.3 14%	23.7 11.2%
>=80% reduction	13.4 6.4%	23.7 11.2%	22.6 10.8%	19.3 9.1%
>=90% reduction	8.6 4.1%	13.3 6.3%	13.9 6.7%	9.2 4.4%
=100% reduction	2.4 1.1%	6.2 2.9%	5.8 2.8%	3.4 1.6%

17. Secondary Outcome

Title	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0%; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
>0% reduction	81.3 38.9%	89.6 42.5%	86.5 41.4%	85.0 40.3%
>=10% reduction	72.7 34.8%	83.4 39.5%	79.8 38.2%	75.4 35.7%
>=20% reduction	59.3 28.4%	78.7 37.3%	72.6 34.7%	65.7 31.1%
>=30% reduction	48.8 23.3%	71.1 33.7%	64.4 30.8%	58.9 27.9%
>=40% reduction	40.7 19.5%	64.5 30.6%	56.3 26.9%	50.7 24%
>=50% reduction	35.4 16.9%	58.8 27.9%	51.0 24.4%	46.9 22.2%
>=60% reduction	29.2 14%	49.8 23.6%	44.2 21.1%	37.7 17.9%
>=70% reduction	20.6 9.9%	42.2 20%	32.2 15.4%	26.6 12.6%
>=80% reduction	13.9 6.7%	25.6 12.1%	24.5 11.7%	21.7 10.3%
>=90% reduction	9.1 4.4%	14.2 6.7%	14.9 7.1%	10.6 5%
=100% reduction	2.9 1.4%	6.2 2.9%	6.3 3%	4.3 2%

18. Secondary Outcome

Title	Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF)
Description	Participants assessed their average daily pain score in the index hip/knee using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. A weekly mean was calculated using the daily index hip/knee pain scores within each specified study week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	207	206	206	211
Change at Week 2	-1.11 (2.06)	-1.75 (2.20)	-1.70 (2.32)	-2.02 (2.29)
Change at Week 4	-1.43 (2.25)	-2.34 (2.44)	-2.46 (2.54)	-2.11 (2.37)
Change at Week 8	-1.39 (2.27)	-2.33 (2.47)	-2.37 (2.59)	-2.01 (2.37)
Change at Week 12	-1.52 (2.46)	-2.39 (2.57)	-2.36 (2.83)	-2.02 (2.54)
Change at Week 16	-1.60 (2.51)	-2.38 (2.68)	-2.18 (2.80)	-1.82 (2.52)

19. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Baseline	7.19 (1.88)	7.07 (1.67)	7.11 (1.85)	6.96 (1.99)
Change at Week 2	-1.54 (2.51)	-2.52 (2.59)	-2.39 (2.77)	-2.45 (2.51)
Change at Week 4	-1.69 (2.58)	-3.18 (2.63)	-3.10 (2.96)	-2.51 (2.47)
Change at Week 8	-1.74 (2.57)	-3.31 (2.79)	-2.90 (3.09)	-2.32 (2.41)
Change at Week 12	-1.72 (2.69)	-3.21 (2.84)	-3.06 (3.24)	-2.41 (2.67)
Change at Week 16	-1.74 (2.76)	-3.17 (2.89)	-2.95 (3.27)	-2.24 (2.70)

20. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [worst stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no difficulty) to 10 (maximum difficulty), where higher scores indicated worse response.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Baseline	7.21 (1.35)	7.06 (1.38)	7.19 (1.39)	7.07 (1.47)
Change at week 2	-1.75 (2.07)	-2.50 (2.35)	-2.38 (2.48)	-2.63 (2.31)
Change at week 4	-1.92 (2.28)	-3.23 (2.46)	-3.11 (2.75)	-2.68 (2.27)
Change at week 8	-1.91 (2.32)	-3.26 (2.58)	-2.94 (2.79)	-2.52 (2.24)
Change at week 12	-1.85 (2.54)	-3.22 (2.67)	-3.08 (2.98)	-2.56 (2.48)
Change at week 16	-1.88 (2.59)	-3.17 (2.68)	-2.94 (3.01)	-2.37 (2.53)

21. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	208	207
Baseline	7.36 (1.60)	7.16 (1.61)	7.23 (1.59)	7.22 (1.61)
Change at Week 2	-2.14 (2.30)	-2.64 (2.60)	-2.44 (2.75)	-3.03 (2.68)
Change at Week 4	-2.18 (2.46)	-3.38 (2.83)	-3.26 (2.84)	-3.05 (2.55)
Change at Week 8	-2.23 (2.54)	-3.29 (2.75)	-3.00 (2.84)	-2.82 (2.71)
Change at Week 12	-2.21 (2.76)	-3.34 (2.90)	-3.20 (3.05)	-2.80 (2.74)
Change at Week 16	-2.19 (2.78)	-3.22 (2.90)	-2.95 (3.10)	-2.64 (2.81)

22. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	208	211	208	207
Baseline	8.33 (1.36)	8.05 (1.50)	8.22 (1.38)	8.24 (1.45)
Change at Week 2	-1.97 (2.33)	-2.84 (2.64)	-2.64 (2.72)	-2.93 (2.60)
Change at Week 4	-2.19 (2.50)	-3.54 (2.77)	-3.35 (2.94)	-3.07 (2.53)
Change at Week 8	-2.12 (2.57)	-3.44 (2.92)	-3.30 (2.99)	-2.88 (2.52)
Change at Week 12	-2.05 (2.83)	-3.43 (3.03)	-3.38 (3.15)	-2.84 (2.67)
Change at Week 16	-2.06 (2.85)	-3.33 (3.04)	-3.11 (3.17)	-2.61 (2.87)

23. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum), where higher score indicated a better health related quality of life.
Time Frame	Baseline, Weeks 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Change at Week 12: General Health	1.11 (11.12)	3.51 (13.04)	4.02 (13.89)	3.05 (13.72)
Change at Week 16: General Health	1.43 (10.42)	5.02 (12.38)	3.41 (13.01)	3.12 (11.52)
Change at Week 12: Physical Function	9.45 (20.05)	18.57 (23.26)	18.40 (26.35)	11.78 (21.57)
Change at Week 16: Physical Function	8.80 (17.69)	17.26 (21.04)	15.93 (24.85)	11.22 (20.80)
Change at Week 12: Role Physical	10.62 (23.47)	19.43 (25.69)	16.66 (24.67)	13.22 (23.75)
Change at Week 16: Role Physical	8.85 (22.75)	17.95 (26.59)	15.22 (24.95)	11.48 (24.21)
Change at Week 12: Bodily Pain	11.13 (21.91)	21.89 (23.40)	20.40 (24.28)	15.06 (20.71)
Change at Week 16: Bodily Pain	10.33 (20.62)	19.73 (24.00)	17.54 (24.42)	13.95 (19.22)
Change at Week 12:Vitality	3.85 (14.45)	9.05 (15.00)	6.52 (17.53)	4.37 (18.21)
Change at Week 16:Vitality	4.75 (13.97)	9.55 (15.76)	6.97 (17.53)	6.79 (17.00)
Change at Week 12: Social Function	4.13 (17.16)	10.12 (22.75)	8.07 (22.66)	7.24 (23.78)
Change at Week 16: Social Function	5.44 (17.23)	10.00 (20.31)	7.30 (20.23)	7.72 (22.69)
Change at Week 12: Role Emotional	3.47 (19.48)	8.02 (23.00)	8.41 (23.96)	1.75 (28.39)
Change at Week 16: Role Emotional	3.79 (18.43)	8.49 (22.13)	7.93 (23.02)	3.71 (25.24)
Change at Week 12: Mental Health	1.42 (12.91)	3.17 (13.29)	3.33 (15.44)	3.09 (15.88)
Change at Week 16: Mental Health	1.59 (11.64)	3.74 (12.35)	3.52 (15.81)	2.89 (13.60)

24. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.
Time Frame	Baseline, Weeks 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Change at Week 12: MCA	0.01 (0.73)	0.10 (0.85)	0.09 (0.90)	0.01 (1.06)
Change at Week 16: MCA	0.07 (0.67)	0.16 (0.81)	0.12 (0.87)	0.10 (0.90)
Change at Week 12: PCA	0.43 (0.78)	0.83 (0.99)	0.77 (0.95)	0.58 (0.81)
Change at Week 16: PCA	0.39 (0.72)	0.76 (0.95)	0.66 (0.94)	0.52 (0.76)

25. 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 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Median (Full Range) [days]	NA	NA	NA	NA

26. 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 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Mean (Standard Error) [days]	87.78 (2.23)	80.12 (1.09)	84.62 (1.37)	72.87 (1.07)

27. Secondary Outcome

Title	Percentage of Participants Who Used Rescue Medication
Description	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here 'number analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Week 2	61.6 29.5%	63.3 30%	68.9 33%	46.6 22.1%
Week 4	52.5 25.1%	47.1 22.3%	45.6 21.8%	36.5 17.3%
Week 8	47.8 22.9%	38.9 18.4%	37.9 18.1%	35.4 16.8%
Week 12	42.7 20.4%	33.2 15.7%	33.5 16%	33.5 15.9%
Week 16	37.4 17.9%	33.2 15.7%	33.5 16%	30.1 14.3%

28. Secondary Outcome

Title	Duration of Rescue Medication Use
Description	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here 'number analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Week 2	1	2	2	0
Week 4	1	0	0	0
Week 8	0	0	0	0
Week 12	0	0	0	0
Week 16	0	0	0	0

29. Secondary Outcome

Title	Amount of Rescue Medication Taken
Description	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here 'number analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Week 2	3967.98 (5614.49)	3661.84 (5025.34)	3325.24 (4143.00)	2069.71 (3851.87)
Week 4	3392.16 (5588.13)	2442.31 (4423.97)	2648.06 (4653.47)	1713.94 (3652.96)
Week 8	3329.27 (5733.90)	2024.04 (4124.50)	2274.27 (4692.11)	1956.94 (4967.74)
Week 12	3055.83 (5712.68)	2012.02 (4261.23)	1963.59 (4531.99)	1851.67 (3918.89)
Week 16	3155.34 (5899.37)	1968.75 (4265.10)	2014.56 (4631.26)	1827.75 (4138.99)

30. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame	Baseline (Day 1) up to Week 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo).

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
AEs	85 40.7%	101 47.9%	101 48.3%	110 52.1%
SAEs	4 1.9%	3 1.4%	4 1.9%	9 4.3%

31. Secondary Outcome

Title	Number of Participants With Laboratory Test Abnormalities
Description	Laboratory values: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3*ULN), electrolytes (sodium<0.95* LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1).
Time Frame	Baseline (Day 1) up to Week 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	201	205	201	204
Count of Participants [Participants]	145 69.4%	145 68.7%	144 68.9%	164 77.7%

32. Secondary Outcome

Title	Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Description	All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as treatment related adverse events were presented. Relatedness to treatment was assessed by investigator.
Time Frame	Baseline (Day 1) up to Week 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo).

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
QRS complex abnormal	0 0%	1 0.5%	0 0%	0 0%
T wave abnormal	0 0%	0 0%	1 0.5%	0 0%
T wave inversion	0 0%	0 0%	1 0.5%	0 0%
Bradycardia	0 0%	0 0%	1 0.5%	0 0%
Ventricular extrasystoles	0 0%	0 0%	1 0.5%	0 0%

33. Secondary Outcome

Title	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24
Description	NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 122 (maximum impairment), higher scores indicated increased impairment.
Time Frame	Baseline, Weeks 2, 4, 8, 12, 16, and 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here 'number analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each arm, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Baseline	1.52 (3.29)	1.38 (3.04)	0.92 (2.64)	1.14 (3.18)
Change at Week 2	-0.22 (1.40)	-0.21 (1.65)	0.00 (1.85)	-0.08 (1.60)
Change at Week 4	-0.26 (1.87)	-0.13 (1.75)	-0.26 (2.13)	-0.18 (1.54)
Change at Week 8	-0.31 (1.52)	-0.15 (1.66)	-0.19 (1.65)	-0.17 (1.78)
Change at Week 12	-0.29 (1.63)	-0.32 (1.55)	0.10 (2.64)	-0.28 (1.78)
Change at Week 16	-0.52 (1.68)	-0.25 (1.37)	-0.13 (1.54)	-0.30 (1.80)

34. Secondary Outcome

Title	Number of Participants With Positive Anti-Drug Antibody (ADA) Level
Description	Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: Tanezumab 5 mg + Placebo and Tanezumab 10 mg + Placebo. Results with titer value >= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive.
Time Frame	Baseline, Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. This outcome measure was planned not to be analyzed for reporting arms: Placebo and Naproxen + Placebo.

Arm/Group Title	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo
Arm/Group Description	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.
Measure Participants	211	209
Baseline	0 0%	1 0.5%
Week 8	1 0.5%	0 0%
Week 16	0 0%	0 0%
Week 24	0 0%	0 0%

35. Secondary Outcome

Title	Number of Participants With Abnormal Physical Examinations Findings
Description	Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others. Criteria for abnormal physical findings were based on investigator's discretion.
Time Frame	Baseline (Day 1)

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here, 'number analyzed' signifies those participants who were evaluable for each specified category for each group, respectively.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Abdomen	19 9.1%	12 5.7%	11 5.3%	15 7.1%
Ears	5 2.4%	11 5.2%	7 3.3%	6 2.8%
Extremities	40 19.1%	47 22.3%	29 13.9%	33 15.6%
Eyes	9 4.3%	11 5.2%	6 2.9%	15 7.1%
General	14 6.7%	12 5.7%	3 1.4%	17 8.1%
Head	6 2.9%	3 1.4%	5 2.4%	8 3.8%
Heart	7 3.3%	6 2.8%	5 2.4%	8 3.8%
Lungs	5 2.4%	3 1.4%	1 0.5%	1 0.5%
Musculoskeletal	87 41.6%	89 42.2%	81 38.8%	88 41.7%
Neck	7 3.3%	4 1.9%	4 1.9%	2 0.9%
Nose	2 1%	0 0%	1 0.5%	0 0%
Skin	31 14.8%	23 10.9%	31 14.8%	34 16.1%
Throat	6 2.9%	1 0.5%	3 1.4%	3 1.4%
Thyroid	1 0.5%	2 0.9%	2 1%	3 1.4%

36. Secondary Outcome

Title	Number of Participants With Adverse Events Associated With Vital Sign Measurements
Description	Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant vital signs (based on the investigator's judgment) considered as adverse events were reported.
Time Frame	Baseline (Day 1) up to Week 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo).

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.	Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.	Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
Measure Participants	209	211	209	211
Count of Participants [Participants]	3 1.4%	6 2.8%	5 2.4%	6 2.8%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Arm/Group Title	Placebo		Tanezumab 5 mg + Placebo		Tanezumab 10 mg + Placebo		Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.		Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.		Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.		Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.
All Cause Mortality
	Placebo		Tanezumab 5 mg + Placebo		Tanezumab 10 mg + Placebo		Naproxen + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Tanezumab 5 mg + Placebo		Tanezumab 10 mg + Placebo		Naproxen + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/209 (1.9%)		3/211 (1.4%)		4/209 (1.9%)		9/211 (4.3%)
Blood and lymphatic system disorders
Anaemia	0/209 (0%)		0/211 (0%)		0/209 (0%)		1/211 (0.5%)
Cardiac disorders
Atrial flutter	1/209 (0.5%)		0/211 (0%)		0/209 (0%)		0/211 (0%)
Myocardial infarction	0/209 (0%)		0/211 (0%)		0/209 (0%)		1/211 (0.5%)
Gastrointestinal disorders
Colitis ischaemic	0/209 (0%)		0/211 (0%)		1/209 (0.5%)		0/211 (0%)
Gastrointestinal haemorrhage	0/209 (0%)		0/211 (0%)		0/209 (0%)		1/211 (0.5%)
Small intestine ulcer	0/209 (0%)		0/211 (0%)		0/209 (0%)		1/211 (0.5%)
Immune system disorders
Sarcoidosis	0/209 (0%)		0/211 (0%)		0/209 (0%)		1/211 (0.5%)
Infections and infestations
Breast cellulitis	0/209 (0%)		0/211 (0%)		0/209 (0%)		1/211 (0.5%)
Pneumonia	0/209 (0%)		1/211 (0.5%)		0/209 (0%)		0/211 (0%)
Respiratory tract infection	0/209 (0%)		0/211 (0%)		0/209 (0%)		1/211 (0.5%)
Sepsis	1/209 (0.5%)		0/211 (0%)		0/209 (0%)		0/211 (0%)
Urinary tract infection	0/209 (0%)		1/211 (0.5%)		0/209 (0%)		0/211 (0%)
Injury, poisoning and procedural complications
Drug exposure during pregnancy	0/209 (0%)		1/211 (0.5%)		0/209 (0%)		0/211 (0%)
Hip fracture	0/209 (0%)		1/211 (0.5%)		0/209 (0%)		1/211 (0.5%)
Pelvic fracture	0/209 (0%)		0/211 (0%)		1/209 (0.5%)		0/211 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	2/209 (1%)		0/211 (0%)		0/209 (0%)		1/211 (0.5%)
Nervous system disorders
Hyperaesthesia	0/209 (0%)		0/211 (0%)		1/209 (0.5%)		0/211 (0%)
Ischaemic stroke	0/209 (0%)		0/211 (0%)		1/209 (0.5%)		0/211 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/209 (0%)		1/211 (0.5%)		0/209 (0%)		0/211 (0%)
Psychiatric disorders
Mental status changes	0/209 (0%)		1/211 (0.5%)		0/209 (0%)		0/211 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/209 (0%)		1/211 (0.5%)		0/209 (0%)		0/211 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Tanezumab 5 mg + Placebo		Tanezumab 10 mg + Placebo		Naproxen + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/209 (18.2%)		69/211 (32.7%)		62/209 (29.7%)		58/211 (27.5%)
Gastrointestinal disorders
Constipation	1/209 (0.5%)		2/211 (0.9%)		0/209 (0%)		6/211 (2.8%)
Diarrhoea	1/209 (0.5%)		3/211 (1.4%)		5/209 (2.4%)		5/211 (2.4%)
Dyspepsia	4/209 (1.9%)		3/211 (1.4%)		2/209 (1%)		10/211 (4.7%)
General disorders
Fatigue	1/209 (0.5%)		1/211 (0.5%)		6/209 (2.9%)		0/211 (0%)
Oedema peripheral	2/209 (1%)		4/211 (1.9%)		11/209 (5.3%)		4/211 (1.9%)
Infections and infestations
Bronchitis	2/209 (1%)		6/211 (2.8%)		1/209 (0.5%)		2/211 (0.9%)
Nasopharyngitis	2/209 (1%)		8/211 (3.8%)		4/209 (1.9%)		5/211 (2.4%)
Upper respiratory tract infection	2/209 (1%)		8/211 (3.8%)		6/209 (2.9%)		5/211 (2.4%)
Urinary tract infection	6/209 (2.9%)		5/211 (2.4%)		6/209 (2.9%)		6/211 (2.8%)
Injury, poisoning and procedural complications
Fall	5/209 (2.4%)		6/211 (2.8%)		4/209 (1.9%)		5/211 (2.4%)
Investigations
Blood creatine phosphokinase increased	1/209 (0.5%)		4/211 (1.9%)		6/209 (2.9%)		1/211 (0.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/209 (1%)		12/211 (5.7%)		12/209 (5.7%)		9/211 (4.3%)
Back pain	1/209 (0.5%)		6/211 (2.8%)		3/209 (1.4%)		1/211 (0.5%)
Pain in extremity	1/209 (0.5%)		4/211 (1.9%)		11/209 (5.3%)		2/211 (0.9%)
Nervous system disorders
Burning sensation	0/209 (0%)		2/211 (0.9%)		5/209 (2.4%)		2/211 (0.9%)
Dizziness	3/209 (1.4%)		2/211 (0.9%)		5/209 (2.4%)		3/211 (1.4%)
Headache	6/209 (2.9%)		9/211 (4.3%)		7/209 (3.3%)		6/211 (2.8%)
Hypoaesthesia	0/209 (0%)		7/211 (3.3%)		2/209 (1%)		2/211 (0.9%)
Paraesthesia	2/209 (1%)		13/211 (6.2%)		12/209 (5.7%)		5/211 (2.4%)
Respiratory, thoracic and mediastinal disorders
Cough	4/209 (1.9%)		6/211 (2.8%)		3/209 (1.4%)		1/211 (0.5%)

Limitations/Caveats

[Not Specified]

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.