Tanezumab In Osteoarthritis Of The Knee (2)

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00830063
• Collaborator: (none)
• Enrollment: 832
• Locations: 94
• Arms: 4
• Actual Duration (Months): 15.9
• Patients Per Site: 8.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to 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
Arthritis; Osteoarthritis	Biological: tanezumab 10 mg; Biological: tanezumab 5 mg; Drug: naproxen; Other: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 832 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 KNEE
• Actual Study Start Date: May 5, 2009
• Actual Primary Completion Date: May 17, 2010
• Actual Study Completion Date: Aug 31, 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 (Day 1), Week 16]

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more 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 in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

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

   Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.

Secondary Outcome Measures

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

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.

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

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.

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

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

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

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

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

   Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.

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

   Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.

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

   A participant was considered as an 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 or physical function subscale; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 [minimum affected] to 5 [maximum affected], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.

8. Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF) [Week 2, 4, 8, 12, 16]

   A participant was considered as an 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 or physical function subscale; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 [minimum affected] to 5 [maximum affected], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.

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

   WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.

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

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.

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

    Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.

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

    Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.

13. Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities 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 in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (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 Universities 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 in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (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.

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

    Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.

16. Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) [Baseline, Week 2, 4, 8, 12, 16]

    Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.

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

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.

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

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.

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

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [minimum stiffness] to 10 [maximum stiffness], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.

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

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [minimum stiffness] to 10 [maximum stiffness], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.

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

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

22. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) [Baseline, Week 2, 4, 8, 12, 16]

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

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

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

24. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) [Baseline, Week 2, 4, 8, 12, 16]

    WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

25. Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF) [Baseline, Week 12, 16]

    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 and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). 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.

26. Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF) [Baseline, Week 12, 16]

    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 and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). 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.

27. 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.

28. Percentage of Participants Who Used Rescue Medication [Week 2, 4, 8, 12, 16]

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

29. Number of Days Participants Used Rescue Medication [Week 2, 4, 8, 12, 16]

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

30. Amount of Rescue Medication Taken [Week 2, 4, 8, 12, 16]

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

Other Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) [Day 1 (Baseline) 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.

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

   Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;cholesterol,triglycerides>1.3*ULN;sodium <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN,phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLN or >1.5*ULN,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).

3. Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities [Day 1 (Baseline) up to Week 24]

   Criteria for potential clinical concern in ECG parameters are: Criterion 1= maximum QTcB interval (Bazett's correction) in range of 450 millisecond (msec) to less than 480 msec, Criterion 2= maximum QTcB interval in range of 480 msec to less than 500 msec, Criterion 3= maximum QTcB interval >= 500 msec; Criterion 4= maximum QTcF interval (Fridericia's correction) in range of 450 msec to less than 480 msec, Criterion 5= maximum QTcF interval in range of 480 msec to less than 500 msec, Criterion 6= maximum QTcF interval >= 500 msec, Criterion 7= maximum QTcB interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 8= maximum QTcB interval increase >=60 msec, Criterion 9= maximum QTcF interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 10= maximum QTcF interval increase >=60 msec.

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

   NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items from both the left and right side, 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 244 (maximum impairment), higher scores indicate increased impairment.

5. Number of Participants With Positive Anti-Drug Antibody (ADA) Level [Baseline, Week 8, 16, 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.

6. Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities [Day 1 (Baseline) up to Week 24]

   Assessment of the clinical significance of vital sign changes was done per investigator judgment. Changes in vital signs determined to be clinically significant by the investigator were reported as adverse events.

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 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, neurologic or cardiac disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anniston Medical Clinic, PC	Anniston	Alabama	United States	36207
2	Pinnaccle Research Group, LLC	Anniston	Alabama	United States	36207
3	Clinical Research Advantage, Inc. / Mesa Family Medical Center, PC	Mesa	Arizona	United States	85203
4	Arizona Arthritis & Rheumatology Associates, P.C.	Paradise Valley	Arizona	United States	85253
5	Pivotal Research Centers	Peoria	Arizona	United States	85381
6	Arizona Research Center	Phoenix	Arizona	United States	85023
7	Arizona Arthritis & Rheumatology Associates, P.C.	Phoenix	Arizona	United States	85037
8	University of Arizona - Arizona Arthritis Center	Tucson	Arizona	United States	85724
9	University of Arizona	Tucson	Arizona	United States	85724
10	St. Joseph's Mercy Clinic	Hot Springs	Arkansas	United States	71913
11	Osteoporosis Medical Center	Beverly Hills	California	United States	90211
12	Valley Research	Fresno	California	United States	93720
13	Talbert Medical Group	Huntington Beach	California	United States	92646
14	UC Davis Medical Center	Sacramento	California	United States	95817
15	Lawrence P McAdam, MD / A Medical Corporation	Thousand Oaks	California	United States	91360
16	Stamford Therapeutics Consortium	Stamford	Connecticut	United States	06905
17	Javed Rheumatology Associates, Inc.	Newark	Delaware	United States	19713
18	Innovative Research of West Florida, Inc	Clearwater	Florida	United States	33756
19	Tampa Bay Medical Research, Inc.	Clearwater	Florida	United States	33761
20	Clinical Research of South Florida	Coral Gables	Florida	United States	33134
21	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
22	Westside Center for Clinical Research	Jacksonville	Florida	United States	32205
23	Adult Medicine Specialists	Longwood	Florida	United States	32779
24	Genesis Research International	Longwood	Florida	United States	32779
25	Kendall South Medical Center, Inc	Miami	Florida	United States	33175
26	The Arthritis Center	Palm Harbor	Florida	United States	34684
27	University Clinical Research, Inc.	Pembroke Pines	Florida	United States	33024
28	Progressive Medical Research	Port Orange	Florida	United States	32127
29	West Broward Rheumatology Associates, Inc.	Tamarac	Florida	United States	33321
30	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
31	Arthritis and Rheumatology of Georgia	Atlanta	Georgia	United States	30342
32	Jeffrey D. Lieberman, MD	Decatur	Georgia	United States	30033
33	Marietta Rheumatology	Marietta	Georgia	United States	30060
34	Physician Pain Care	Woodstock	Georgia	United States	30188
35	North Georgia Clinical Research	Woodstock	Georgia	United States	30189
36	North Georgia Internal Medicine	Woodstock	Georgia	United States	30189
37	Sonora Clinical Research	Boise	Idaho	United States	83702
38	Rehabilitation Institute of Chicago	Chicago	Illinois	United States	60611
39	Illinois Bone and Joint Institute, LLC	Morton Grove	Illinois	United States	60053
40	Koch Family Practice	Morton	Illinois	United States	61550
41	The Arthritis Center	Springfield	Illinois	United States	62704
42	Northwest Indiana Center for Clinical Research	Valparaiso	Indiana	United States	46383
43	McFarland Clinic, PC	Ames	Iowa	United States	50010
44	Integrated Clinical Trial Services, Inc.	West Des Moines	Iowa	United States	50265
45	Professional Research Network of Kansas, LLC	Wichita	Kansas	United States	67203
46	David H. Neustadt, PSC	Louisville	Kentucky	United States	40202
47	Stanocola Medical Center	Baton Rouge	Louisiana	United States	70816
48	Maine Research Associates	Auburn	Maine	United States	04210
49	Arthritis and Osteoporosis Center of Maryland	Frederick	Maryland	United States	21702
50	The Center for Rheumatology and Bone Research	Wheaton	Maryland	United States	20902
51	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01610
52	Shores Rheumatology, P.C.	Saint Clair Shores	Michigan	United States	48081
53	MAPS Applied Research Center, Inc	Edina	Minnesota	United States	55435
54	Medical Advanced Pain Specialists	Edina	Minnesota	United States	55435
55	Mercy Health Research	Saint Louis	Missouri	United States	63141
56	Quality Clinical Research, Inc.	Omaha	Nebraska	United States	68114
57	Clinical Research Consortium	Las Vegas	Nevada	United States	89119
58	Mirkil Medical	Las Vegas	Nevada	United States	89119
59	G. Timothy Kelly, MD	Las Vegas	Nevada	United States	89128
60	Michael Clifford, MD	Las Vegas	Nevada	United States	89128
61	Comprehensive Clinical Research	Berlin	New Jersey	United States	08009
62	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico	United States	87102
63	New Mexico Clinical Research & Osteoporosis Center, Incorporated	Albuquerque	New Mexico	United States	87106
64	The Medical Research Network, LLC	New York	New York	United States	10024
65	AAIR Research Center	Rochester	New York	United States	14618
66	Andrew J. Porges, MD, PC	Roslyn	New York	United States	11576
67	Carolina Bone and Joint, PA	Charlotte	North Carolina	United States	28210
68	Pharmquest	Greensboro	North Carolina	United States	27408
69	Odyssey Research	Fargo	North Dakota	United States	58104
70	Plains Medical Clinic, LLC	Fargo	North Dakota	United States	58104
71	Hightop Medical Research Center	Cincinnati	Ohio	United States	45224
72	Hilltop Physicians Inc / Hightop Medical Research Center	Cincinnati	Ohio	United States	45224
73	Southwest Rheumatology and Research Group, LLC	Middleburg Heights	Ohio	United States	44130
74	Pharmacotherapy Research Associates Incorporated	Zanesville	Ohio	United States	43701
75	Health Research Institute	Oklahoma City	Oklahoma	United States	73109
76	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
77	Clinical Research Center of Reading, LLP	West Reading	Pennsylvania	United States	19611
78	Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
79	Health Concepts	Rapid City	South Dakota	United States	57702
80	Appalachian Medical Research, Inc	Johnson City	Tennessee	United States	37604
81	Holston Medical Group	Kingsport	Tennessee	United States	37660
82	Capitol Medical Clinic	Austin	Texas	United States	78705
83	Office of Walter F Chase, MD, PA	Austin	Texas	United States	78705
84	North Texas Joint Care, PA	Dallas	Texas	United States	75230
85	Asif Cochinwala, MD, PA	Houston	Texas	United States	77008
86	Pioneer Research Solutions, Inc	Houston	Texas	United States	77036
87	Radiant Research San Antonio Northeast	San Antonio	Texas	United States	78217
88	Diagnostic Research Group	San Antonio	Texas	United States	78229
89	Diagnostics Research Group	San Antonio	Texas	United States	78229
90	South Texas Radiology Group	San Antonio	Texas	United States	78229
91	Aspen Clinical Research, LLC	Orem	Utah	United States	84058
92	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia	United States	23502
93	Arthritis and Rheumatic Diseases	Portsmouth	Virginia	United States	23701
94	Clinical Trials Northwest	Yakima	Washington	United States	98902

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: NCT00830063
• Other Study ID Numbers: A4091015; P3 OA KNEE NSAID POPULATION
• First Posted: Jan 27, 2009
• Last Update Posted: May 13, 2021
• Last Verified: Apr 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
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Period Title: Overall Study
STARTED	208	208	208	208
Treated	208	206	208	206
COMPLETED	8	16	10	13
NOT COMPLETED	200	192	198	195

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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.	Total of all reporting groups
Overall Participants	208	206	208	206	828
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.9 (10.1)	61.1 (10.1)	61.1 (10.3)	61.4 (10)	61.1 (10.1)
Sex: Female, Male (Count of Participants)
Female	120 57.7%	122 59.2%	128 61.5%	129 62.6%	499 60.3%
Male	88 42.3%	84 40.8%	80 38.5%	77 37.4%	329 39.7%

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 in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Time Frame	Baseline (Day 1), Week 16

Outcome Measure Data

Analysis Population Description

Modified ITT (mITT): All participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here "Overall number of participants analyzed (N)" signifies the participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	7.21 (1.43)	7.30 (1.47)	7.25 (1.41)	7.18 (1.37)
Change at Week 16	-2.23 (2.56)	-3.55 (2.84)	-3.27 (2.81)	-2.82 (2.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Least square (LS) mean was estimated from the corresponding analysis of covariance (ANCOVA) model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95 percent (%) confidence interval (CI) was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	-1.24
	Confidence Interval	(2-Sided) 95%; -1.76 to -0.72
	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	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.00
	Confidence Interval	(2-Sided) 95%; -1.52 to -0.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.72
	Confidence Interval	(2-Sided) 95%; -1.23 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.068
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 95%; -0.99 to 0.03
	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 in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here 'N' signifies the participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	198	202	201	200
Baseline	6.85 (1.56)	6.86 (1.71)	6.86 (1.50)	6.86 (1.57)
Change at Week 16	-1.88 (2.29)	-3.18 (2.64)	-2.91 (2.59)	-2.42 (2.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.25
	Confidence Interval	(2-Sided) 95%; -1.73 to -0.77
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.03
	Confidence Interval	(2-Sided) 95%; -1.51 to -0.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.76
	Confidence Interval	(2-Sided) 95%; -1.24 to -0.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.53
	Confidence Interval	(2-Sided) 95%; -1.01 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

3. Primary Outcome

Title	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
Description	Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	198	201	202	200
Baseline	3.41 (0.61)	3.41 (0.59)	3.39 (0.55)	3.44 (0.62)
Change at Week 16	-0.53 (0.83)	-0.87 (1.02)	-0.74 (0.88)	-0.70 (0.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95%; -0.50 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.39 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.36 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.349
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95%; -0.25 to 0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Time Frame	Baseline, Week 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Change at Week 2	-2.34 (2.26)	-2.61 (2.58)	-2.95 (2.53)	-3.12 (2.37)
Change at Week 4	-2.36 (2.31)	-3.59 (2.52)	-3.99 (2.64)	-3.28 (2.41)
Change at Week 8	-2.35 (2.35)	-3.63 (2.61)	-3.89 (2.77)	-3.13 (2.57)
Change at Week 12	-2.24 (2.56)	-3.89 (2.83)	-3.65 (2.92)	-2.98 (2.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.355
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95%; -1.04 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95%; 0.09 to 1.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.388
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; -0.26 to 0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.18
	Confidence Interval	(2-Sided) 95%; -1.65 to -0.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.60
	Confidence Interval	(2-Sided) 95%; -2.07 to -1.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.274
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.26
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.69
	Confidence Interval	(2-Sided) 95%; -1.16 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.25
	Confidence Interval	(2-Sided) 95%; -1.74 to -0.75
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.50
	Confidence Interval	(2-Sided) 95%; -2.00 to -1.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.051
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -0.99 to 0.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.75
	Confidence Interval	(2-Sided) 95%; -1.24 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.59
	Confidence Interval	(2-Sided) 95%; -2.12 to -1.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.37
	Confidence Interval	(2-Sided) 95%; -1.90 to -0.85
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.89
	Confidence Interval	(2-Sided) 95%; -1.42 to -0.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.67
	Confidence Interval	(2-Sided) 95%; -1.19 to -0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Time Frame	Baseline, Week 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	7.21 (1.43)	7.30 (1.47)	7.25 (1.41)	7.18 (1.37)
Change at Week 2	-2.34 (2.26)	-2.61 (2.58)	-2.95 (2.53)	-3.12 (2.37)
Change at Week 4	-2.53 (2.32)	-3.58 (2.56)	-4.14 (2.51)	-3.32 (2.39)
Change at Week 8	-2.62 (2.35)	-3.73 (2.60)	-4.24 (2.53)	-3.26 (2.52)
Change at Week 12	-2.80 (2.50)	-4.07 (2.72)	-4.21 (2.56)	-3.34 (2.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.355
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95%; -1.04 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95%; 0.09 to 1.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.388
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; -0.26 to 0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.98
	Confidence Interval	(2-Sided) 95%; -1.45 to -0.52
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.56
	Confidence Interval	(2-Sided) 95%; -2.02 to -1.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.361
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.68 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 95%; -1.25 to -0.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.06
	Confidence Interval	(2-Sided) 95%; -1.54 to -0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.57
	Confidence Interval	(2-Sided) 95%; -2.04 to -1.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.063
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -0.93 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.96
	Confidence Interval	(2-Sided) 95%; -1.43 to -0.48
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.20
	Confidence Interval	(2-Sided) 95%; -1.70 to -0.71
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.35
	Confidence Interval	(2-Sided) 95%; -1.85 to -0.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.19 to -0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.85
	Confidence Interval	(2-Sided) 95%; -1.34 to -0.36
	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 Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time Frame	Baseline, Week 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	198	202	201	200
Change at Week 2	-1.92 (2.09)	-2.44 (2.48)	-2.80 (2.35)	-2.66 (2.40)
Change at Week 4	-1.92 (2.19)	-3.07 (2.47)	-3.63 (2.46)	-2.90 (2.38)
Change at Week 8	-1.96 (2.14)	-3.18 (2.47)	-3.50 (2.57)	-2.70 (2.52)
Change at Week 12	-1.93 (2.28)	-3.46 (2.70)	-3.32 (2.72)	-2.66 (2.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.355
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95%; -1.04 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95%; 0.09 to 1.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.388
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; -0.26 to 0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.18
	Confidence Interval	(2-Sided) 95%; -1.65 to -0.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.60
	Confidence Interval	(2-Sided) 95%; -2.07 to -1.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.274
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.26
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.69
	Confidence Interval	(2-Sided) 95%; -1.16 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.25
	Confidence Interval	(2-Sided) 95%; -1.74 to -0.75
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.50
	Confidence Interval	(2-Sided) 95%; -2.00 to -1.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.051
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -0.99 to 0.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.75
	Confidence Interval	(2-Sided) 95%; -1.24 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	-1.59
	Estimated Value	-1.59
	Confidence Interval	(2-Sided) 95%; -2.12 to -1.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.37
	Confidence Interval	(2-Sided) 95%; -1.90 to -0.85
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.89
	Confidence Interval	(2-Sided) 95%; -1.42 to -0.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.67
	Confidence Interval	(2-Sided) 95%; -1.19 to -0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	198	202	201	200
Baseline	6.85 (1.56)	6.86 (1.71)	6.86 (1.50)	6.86 (1.57)
Change at Week 2	-1.92 (2.09)	-2.44 (2.48)	-2.80 (2.35)	-2.66 (2.40)
Change at Week 4	-2.02 (2.23)	-3.07 (2.54)	-3.73 (2.40)	-2.93 (2.37)
Change at Week 8	-2.13 (2.22)	-3.27 (2.50)	-3.77 (2.45)	-2.83 (2.51)
Change at Week 12	-2.31 (2.35)	-3.61 (2.67)	-3.79 (2.51)	-2.95 (2.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.96 to -0.06
	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: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.87
	Confidence Interval	(2-Sided) 95%; -1.32 to -0.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.333
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; -0.23 to 0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.527
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -0.59 to 0.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.03
	Confidence Interval	(2-Sided) 95%; -1.48 to -0.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.71
	Confidence Interval	(2-Sided) 95%; -2.16 to -1.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.574
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.58 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.81
	Confidence Interval	(2-Sided) 95%; -1.26 to -0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.13
	Confidence Interval	(2-Sided) 95%; -1.60 to -0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.64
	Confidence Interval	(2-Sided) 95%; -2.10 to -1.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.055
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -0.92 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from 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 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.27
	Confidence Interval	(2-Sided) 95%; -1.75 to -0.79
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.47
	Confidence Interval	(2-Sided) 95%; -1.95 to -0.99
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.67
	Confidence Interval	(2-Sided) 95%; -1.15 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.87
	Confidence Interval	(2-Sided) 95%; -1.34 to -0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Description	Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.
Time Frame	Baseline, Week 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	198	201	202	200
Change at Week 2	-0.53 (0.78)	-0.69 (0.91)	-0.68 (0.90)	-0.89 (0.94)
Change at Week 4	-0.52 (0.75)	-1.02 (0.98)	-1.07 (0.90)	-0.89 (0.85)
Change at Week 8	-0.52 (0.81)	-0.95 (0.97)	-0.96 (0.95)	-0.77 (0.96)
Change at Week 12	-0.53 (0.74)	-0.98 (1.00)	-0.83 (0.94)	-0.73 (0.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.045
	Comments	P-value was based on ANCOVA from 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 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.33 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; 0.02 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.040
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 95%; 0.01 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.66 to -0.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95%; -0.72 to -0.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.041
	Comments	P-value was based on ANCOVA from 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

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	P-value was based on ANCOVA from 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 -0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from 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 -0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -0.62 to -0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments	P-value was based on ANCOVA from 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 12

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95%; -0.40 to -0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.60 to -0.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from 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 -0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on ANCOVA from 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 -0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.105
	Comments	P-value was based on ANCOVA from 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 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Description	Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.
Time Frame	Baseline, Week 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	198	201	202	200
Baseline	3.41 (0.61)	3.41 (0.59)	3.39 (0.55)	3.44 (0.62)
Change at Week 2	-0.53 (0.78)	-0.69 (0.91)	-0.68 (0.90)	-0.89 (0.94)
Change at Week 4	-0.54 (0.76)	-1.01 (1.01)	-1.10 (0.91)	-0.91 (0.85)
Change at Week 8	-0.56 (0.83)	-0.96 (1.00)	-1.05 (0.95)	-0.81 (0.95)
Change at Week 12	-0.63 (0.83)	-1.01 (1.04)	-0.98 (0.96)	-0.82 (0.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.045
	Comments	P-value was based on ANCOVA from 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 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.33 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; 0.02 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.040
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 95%; 0.01 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 95%; -0.64 to -0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.58
	Confidence Interval	(2-Sided) 95%; -0.74 to -0.42
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.094
	Comments	P-value was based on ANCOVA from 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 8

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95%; -0.40 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95%; -0.57 to -0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.68 to -0.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.032
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.35 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.46 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 5 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 95%; -0.54 to -0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 10 mg + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -0.52 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments	P-value was based on ANCOVA from pairwise comparisons.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.21
	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 16

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg + Placebo, Naproxen + Placebo
	Comments	Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.021
	Comments	P-value was based on ANCOVA from 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

10. Secondary Outcome

Title	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)
Description	A participant was considered as an 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 or physical function subscale; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 [minimum affected] to 5 [maximum affected], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.
Time Frame	Weeks 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Week 2	55.3 26.6%	61.9 30%	69.8 33.6%	67.0 32.5%
Week 4	53.3 25.6%	72.3 35.1%	76.2 36.6%	69.5 33.7%
Week 8	50.3 24.2%	72.8 35.3%	72.8 35%	67.0 32.5%
Week 12	48.7 23.4%	70.8 34.4%	66.8 32.1%	62.5 30.3%
Week 16	50.3 24.2%	66.3 32.2%	63.9 30.7%	61.0 29.6%

11. Secondary Outcome

Title	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)
Description	A participant was considered as an 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 or physical function subscale; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 [minimum affected] to 5 [maximum affected], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.
Time Frame	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Week 2	55.3 26.6%	61.9 30%	69.8 33.6%	67.0 32.5%
Week 4	56.3 27.1%	73.8 35.8%	81.2 39%	70.5 34.2%
Week 8	56.3 27.1%	76.7 37.2%	81.7 39.3%	70.0 34%
Week 12	60.8 29.2%	77.2 37.5%	80.2 38.6%	69.0 33.5%
Week 16	61.8 29.7%	75.2 36.5%	80.2 38.6%	70.0 34%

12. Secondary Outcome

Title	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.
Time Frame	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Week 2: >=30 percent reduction	46.7 22.5%	52.0 25.2%	58.4 28.1%	60.5 29.4%
Week 2: >=50 percent reduction	29.6 14.2%	36.1 17.5%	41.6 20%	44.5 21.6%
Week 4: >=30 percent reduction	47.2 22.7%	65.8 31.9%	72.8 35%	62.5 30.3%
Week 4: >=50 percent reduction	30.7 14.8%	52.0 25.2%	60.9 29.3%	48.5 23.5%
Week 8: >=30 percent reduction	44.7 21.5%	68.3 33.2%	70.3 33.8%	62.5 30.3%
Week 8: >=50 percent reduction	31.7 15.2%	53.0 25.7%	60.4 29%	46.0 22.3%
Week 12: >=30 percent reduction	44.2 21.3%	69.3 33.6%	65.8 31.6%	58.0 28.2%
Week 12: >=50 percent reduction	32.7 15.7%	57.4 27.9%	57.9 27.8%	46.5 22.6%
Week 16: >=30 percent reduction	42.7 20.5%	65.8 31.9%	59.4 28.6%	55.5 26.9%
Week 16: >=50 percent reduction	31.2 15%	52.0 25.2%	52.0 25%	41.5 20.1%

13. Secondary Outcome

Title	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
Description	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.
Time Frame	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Week 2: >=30 percent reduction	46.7 22.5%	52.0 25.2%	58.4 28.1%	60.5 29.4%
Week 2: >=50 percent reduction	29.6 14.2%	36.1 17.5%	41.6 20%	44.5 21.6%
Week 4: >=30 percent reduction	51.3 24.7%	66.8 32.4%	76.7 36.9%	63.5 30.8%
Week 4: >=50 percent reduction	32.7 15.7%	52.0 25.2%	63.4 30.5%	49.5 24%
Week 8: >=30 percent reduction	51.8 24.9%	71.3 34.6%	78.2 37.6%	65.0 31.6%
Week 8: >=50 percent reduction	35.2 16.9%	55.0 26.7%	65.3 31.4%	48.0 23.3%
Week 12: >=30 percent reduction	56.8 27.3%	73.8 35.8%	77.2 37.1%	64.5 31.3%
Week 12: >=50 percent reduction	39.7 19.1%	59.9 29.1%	64.9 31.2%	51.0 24.8%
Week 16: >=30 percent reduction	54.3 26.1%	73.3 35.6%	73.3 35.2%	65.5 31.8%
Week 16: >=50 percent reduction	37.7 18.1%	55.9 27.1%	61.9 29.8%	47.5 23.1%

14. Secondary Outcome

Title	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)
Description	Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Week 2	11.0 5.3%	17.8 8.6%	16.8 8.1%	25.5 12.4%
Week 4	9.0 4.3%	29.7 14.4%	30.0 14.4%	22.0 10.7%
Week 8	9.5 4.6%	29.2 14.2%	28.6 13.8%	19.5 9.5%
Week 12	12.5 6%	31.7 15.4%	24.8 11.9%	18.0 8.7%
Week 16	13.5 6.5%	25.2 12.2%	19.8 9.5%	19.5 9.5%

15. Secondary Outcome

Title	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)
Description	Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Week 2	11.0 5.3%	17.8 8.6%	16.8 8.1%	25.5 12.4%
Week 4	9.0 4.3%	29.7 14.4%	31.5 15.1%	22.5 10.9%
Week 8	10.0 4.8%	29.7 14.4%	31.5 15.1%	20.0 9.7%
Week 12	14.5 7%	33.7 16.4%	29.1 14%	20.5 10%
Week 16	16.0 7.7%	27.7 13.4%	24.6 11.8%	22.5 10.9%

16. Secondary Outcome

Title	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities 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 in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (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

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Greater than (>) 0 percent	57.3 27.5%	73.3 35.6%	69.3 33.3%	71.5 34.7%
>=10 percent	54.3 26.1%	71.8 34.9%	66.3 31.9%	68.0 33%
>=20 percent	50.8 24.4%	68.3 33.2%	64.4 31%	62.0 30.1%
>=30 percent	42.7 20.5%	65.8 31.9%	59.4 28.6%	55.5 26.9%
>=40 percent	36.7 17.6%	60.4 29.3%	56.4 27.1%	50.0 24.3%
>=50 percent	31.2 15%	52.0 25.2%	52.0 25%	41.5 20.1%
>=60 percent	27.6 13.3%	49.5 24%	47.0 22.6%	35.5 17.2%
>=70 percent	22.1 10.6%	39.1 19%	37.6 18.1%	26.0 12.6%
>=80 percent	14.6 7%	29.2 14.2%	25.2 12.1%	18.0 8.7%
>=90 percent	8.0 3.8%	18.8 9.1%	17.8 8.6%	11.0 5.3%
100 percent	3.0 1.4%	8.4 4.1%	7.4 3.6%	4.0 1.9%

17. Secondary Outcome

Title	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities 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 in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (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

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
>0 percent	82.4 39.6%	87.6 42.5%	92.1 44.3%	91.5 44.4%
>=10 percent	75.4 36.3%	83.2 40.4%	86.1 41.4%	83.0 40.3%
>=20 percent	66.8 32.1%	77.7 37.7%	82.2 39.5%	73.0 35.4%
>=30 percent	54.3 26.1%	73.3 35.6%	73.3 35.2%	65.5 31.8%
>=40 percent	45.7 22%	66.3 32.2%	68.3 32.8%	57.0 27.7%
>=50 percent	37.7 18.1%	55.9 27.1%	61.9 29.8%	47.5 23.1%
>=60 percent	31.7 15.2%	53.0 25.7%	54.5 26.2%	41.0 19.9%
>=70 percent	24.6 11.8%	41.6 20.2%	43.6 21%	30.0 14.6%
>=80 percent	15.6 7.5%	29.7 14.4%	28.7 13.8%	21.5 10.4%
>=90 percent	9.0 4.3%	19.3 9.4%	19.8 9.5%	13.0 6.3%
100 percent	3.5 1.7%	8.9 4.3%	7.9 3.8%	5.0 2.4%

18. Secondary Outcome

Title	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	197	200	199	199
Baseline	6.46 (1.83)	6.51 (1.98)	6.58 (1.70)	6.70 (1.99)
Change at Week 2	-1.23 (2.08)	-1.80 (2.45)	-2.08 (2.20)	-2.39 (2.28)
Change at Week 4	-1.34 (2.27)	-2.46 (2.52)	-2.91 (2.52)	-2.33 (2.33)
Change at Week 8	-1.48 (2.34)	-2.52 (2.72)	-2.92 (2.61)	-2.42 (2.63)
Change at Week 12	-1.53 (2.32)	-2.82 (2.80)	-2.79 (2.63)	-2.30 (2.68)
Change at Week 16	-1.44 (2.25)	-2.54 (2.77)	-2.48 (2.67)	-2.21 (2.53)

19. Secondary Outcome

Title	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Description	Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Baseline	6.43 (1.84)	6.51 (1.97)	6.60 (1.70)	6.69 (1.99)
Change at Week 2	-1.25 (2.10)	-1.84 (2.46)	-2.09 (2.20)	-2.39 (2.28)
Change at Week 4	-1.33 (2.38)	-2.58 (2.54)	-2.96 (2.54)	-2.40 (2.32)
Change at Week 8	-1.45 (2.51)	-2.66 (2.69)	-3.13 (2.58)	-2.49 (2.62)
Change at Week 12	-1.68 (2.70)	-3.03 (2.73)	-3.20 (2.59)	-2.67 (2.67)
Change at Week 16	-1.67 (2.68)	-2.79 (2.75)	-2.96 (2.66)	-2.60 (2.56)

20. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale 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 in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	7.04 (1.88)	7.17 (1.72)	7.04 (1.75)	7.02 (1.76)
Change at Week 2	-1.69 (2.36)	-2.63 (2.78)	-2.98 (2.63)	-2.81 (2.67)
Change at Week 4	-1.76 (2.44)	-3.40 (2.81)	-3.84 (2.73)	-2.87 (2.63)
Change at Week 8	-1.77 (2.26)	-3.42 (2.73)	-3.68 (2.81)	-2.60 (2.76)
Change at Week 12	-1.82 (2.40)	-3.73 (2.88)	-3.46 (2.94)	-2.62 (2.70)
Change at Week 16	-1.72 (2.27)	-3.33 (2.84)	-3.16 (2.93)	-2.31 (2.68)

21. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale 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 in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	7.04 (1.88)	7.17 (1.72)	7.04 (1.75)	7.02 (1.76)
Change at Week 2	-1.69 (2.36)	-2.63 (2.78)	-2.98 (2.63)	-2.81 (2.67)
Change at Week 4	-1.81 (2.53)	-3.42 (2.89)	-3.95 (2.63)	-2.92 (2.62)
Change at Week 8	-1.95 (2.34)	-3.57 (2.78)	-4.00 (2.68)	-2.72 (2.78)
Change at Week 12	-2.18 (2.54)	-3.99 (2.86)	-4.05 (2.70)	-2.91 (2.75)
Change at Week 16	-2.07 (2.43)	-3.73 (2.80)	-3.91 (2.68)	-2.73 (2.75)

22. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average 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 in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [minimum stiffness] to 10 [maximum stiffness], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	7.03 (1.48)	7.11 (1.46)	7.05 (1.38)	7.02 (1.37)
Change at Week 2	-1.99 (2.12)	-2.56 (2.47)	-2.91 (2.34)	-2.86 (2.35)
Change at Week 4	-2.02 (2.21)	-3.35 (2.49)	-3.82 (2.49)	-3.02 (2.33)
Change at Week 8	-2.03 (2.14)	-3.41 (2.49)	-3.70 (2.60)	-2.81 (2.49)
Change at Week 12	-2.00 (2.35)	-3.69 (2.69)	-3.48 (2.77)	-2.75 (2.51)
Change at Week 16	-1.95 (2.30)	-3.35 (2.66)	-3.12 (2.69)	-2.52 (2.43)

23. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average 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 in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [minimum stiffness] to 10 [maximum stiffness], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	7.03 (1.48)	7.11 (1.46)	7.05 (1.38)	7.02 (1.37)
Change at Week 2	-1.99 (2.12)	-2.56 (2.47)	-2.91 (2.34)	-2.86 (2.35)
Change at Week 4	-2.13 (2.23)	-3.36 (2.54)	-3.94 (2.38)	-3.06 (2.31)
Change at Week 8	-2.23 (2.18)	-3.52 (2.49)	-4.00 (2.41)	-2.94 (2.45)
Change at Week 12	-2.44 (2.36)	-3.89 (2.61)	-4.02 (2.46)	-3.06 (2.47)
Change at Week 16	-2.37 (2.33)	-3.67 (2.53)	-3.82 (2.38)	-2.96 (2.39)

24. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface 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 in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	7.22 (1.65)	7.16 (1.79)	7.08 (1.70)	7.04 (1.71)
Change at Week 2	-2.40 (2.43)	-2.52 (2.72)	-2.96 (2.65)	-3.05 (2.60)
Change at Week 4	-2.36 (2.49)	-3.49 (2.67)	-3.89 (2.70)	-3.30 (2.48)
Change at Week 8	-2.41 (2.52)	-3.52 (2.78)	-3.80 (2.84)	-3.05 (2.72)
Change at Week 12	-2.28 (2.67)	-3.73 (2.91)	-3.50 (2.98)	-2.98 (2.77)
Change at Week 16	-2.26 (2.70)	-3.39 (3.00)	-3.10 (2.83)	-2.72 (2.63)

25. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface 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 in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	7.22 (1.65)	7.16 (1.79)	7.08 (1.70)	7.04 (1.71)
Change at Week 2	-2.40 (2.43)	-2.52 (2.72)	-2.96 (2.65)	-3.05 (2.60)
Change at Week 4	-2.58 (2.51)	-3.53 (2.65)	-4.02 (2.63)	-3.35 (2.44)
Change at Week 8	-2.71 (2.53)	-3.65 (2.74)	-4.11 (2.66)	-3.23 (2.65)
Change at Week 12	-2.87 (2.64)	-3.94 (2.78)	-4.01 (2.72)	-3.40 (2.66)
Change at Week 16	-2.84 (2.68)	-3.71 (2.83)	-3.77 (2.63)	-3.28 (2.50)

26. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs 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 in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	8.24 (1.33)	8.29 (1.43)	8.15 (1.47)	8.30 (1.35)
Change at Week 2	-2.19 (2.50)	-2.86 (2.78)	-3.10 (2.68)	-3.24 (2.75)
Change at Week 4	-2.18 (2.49)	-3.61 (2.72)	-4.18 (2.90)	-3.39 (2.76)
Change at Week 8	-2.15 (2.55)	-3.65 (2.89)	-3.98 (3.00)	-3.25 (2.86)
Change at Week 12	-2.14 (2.70)	-4.01 (3.00)	-3.79 (3.17)	-3.06 (2.96)
Change at Week 16	-2.21 (2.73)	-3.61 (3.05)	-3.38 (3.09)	-2.93 (2.77)

27. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs 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 in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.
Time Frame	Baseline, Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	199	202	202	200
Baseline	8.24 (1.33)	8.29 (1.43)	8.15 (1.47)	8.30 (1.35)
Change at Week 2	-2.19 (2.50)	-2.86 (2.78)	-3.10 (2.68)	-3.24 (2.75)
Change at Week 4	-2.30 (2.52)	-3.65 (2.70)	-4.33 (2.77)	-3.44 (2.73)
Change at Week 8	-2.38 (2.57)	-3.81 (2.82)	-4.36 (2.77)	-3.40 (2.84)
Change at Week 12	-2.61 (2.68)	-4.25 (2.83)	-4.35 (2.84)	-3.46 (2.91)
Change at Week 16	-2.65 (2.71)	-3.99 (2.84)	-4.10 (2.78)	-3.48 (2.69)

28. Secondary Outcome

Title	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
Description	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 and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). 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, Week 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Baseline: Domain 1	66.03 (19.88)	67.19 (17.71)	67.64 (19.71)	65.16 (19.77)
Change at Week 12:Domain 1	4.13 (11.47)	6.33 (13.62)	3.23 (11.60)	4.12 (13.11)
Change at Week 16:Domain 1	3.42 (11.57)	4.03 (14.02)	3.31 (11.32)	3.62 (12.40)
Baseline: Domain 2	30.45 (19.83)	32.69 (19.88)	34.53 (18.96)	31.93 (18.48)
Change at Week 12:Domain 2	10.15 (18.50)	18.45 (22.97)	17.47 (23.51)	12.69 (19.68)
Change at Week 16:Domain 2	8.74 (17.38)	15.38 (21.77)	13.94 (22.15)	11.08 (19.04)
Baseline: Domain 3	43.62 (25.48)	44.21 (26.10)	46.50 (23.89)	45.44 (25.54)
Change at Week 12:Domain 3	10.77 (22.74)	20.00 (26.45)	17.57 (25.61)	13.03 (24.97)
Change at Week 16:Domain 3	9.64 (21.87)	17.33 (27.01)	15.10 (23.84)	11.69 (22.79)
Baseline: Domain 4	33.72 (17.09)	33.65 (16.04)	33.72 (14.85)	34.02 (16.74)
Change at Week 12:Domain 4	13.67 (20.32)	23.08 (23.15)	21.07 (23.88)	14.93 (20.47)
Change at Week 16:Domain 4	11.23 (18.48)	18.99 (22.90)	16.76 (21.85)	13.19 (21.19)
Baseline: Domain 5	53.09 (20.63)	51.00 (21.81)	52.32 (18.93)	51.84 (20.54)
Change at Week 12:Domain 5	4.39 (12.54)	10.29 (18.21)	6.96 (16.19)	7.19 (14.89)
Change at Week 16:Domain 5	3.98 (13.51)	8.83 (17.22)	7.52 (14.84)	5.66 (14.86)
Baseline: Domain 6	69.28 (27.86)	68.53 (26.43)	69.86 (25.08)	67.94 (25.48)
Change at Week 12:Domain 6	9.05 (21.02)	11.82 (25.32)	8.48 (21.71)	9.44 (20.84)
Change at Week 16:Domain 6	6.97 (20.78)	11.63 (24.76)	7.43 (18.80)	8.00 (22.90)
Baseline: Domain 7	70.69 (32.12)	71.52 (29.63)	72.94 (27.16)	71.54 (29.22)
Change at Week 12:Domain 7	6.03 (19.98)	9.00 (26.96)	6.06 (18.70)	4.88 (24.57)
Change at Week 16:Domain 7	4.61 (23.50)	8.46 (23.88)	4.21 (18.78)	4.62 (21.99)
Baseline: Domain 8	76.06 (18.01)	75.80 (17.76)	74.48 (17.95)	74.91 (17.79)
Change at Week 12:Domain 8	2.94 (11.39)	3.46 (16.38)	3.66 (12.94)	2.56 (13.50)
Change at Week 16:Domain 8	1.66 (13.81)	3.21 (15.31)	2.97 (12.37)	2.31 (13.32)
Baseline: MCA	0.31 (1.27)	0.26 (1.21)	0.25 (1.15)	0.24 (1.21)
Change at Week 12: MCA	0.15 (0.70)	0.16 (1.03)	0.07 (0.76)	0.11 (0.84)
Change at Week 16: MCA	0.09 (0.81)	0.19 (0.93)	0.06 (0.71)	0.10 (0.86)
Baseline: PCA	-1.92 (0.74)	-1.85 (0.76)	-1.78 (0.72)	-1.86 (0.78)
Change at Week 12: PCA	0.47 (0.74)	0.88 (0.90)	0.77 (0.93)	0.59 (0.80)
Change at Week 16: PCA	0.42 (0.73)	0.71 (0.89)	0.66 (0.87)	0.51 (0.81)

29. Secondary Outcome

Title	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
Description	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 and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). 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, Week 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Baseline: Domain 1	66.03 (19.88)	67.19 (17.71)	67.64 (19.71)	65.16 (19.77)
Change at Week 12:Domain 1	4.13 (11.47)	6.33 (13.62)	3.23 (11.60)	4.12 (13.11)
Change at Week 16:Domain 1	3.61 (11.72)	4.76 (14.31)	3.47 (11.73)	4.23 (13.16)
Baseline: Domain 2	30.45 (19.83)	32.69 (19.88)	34.53 (18.96)	31.93 (18.48)
Change at Week 12:Domain 2	10.15 (18.50)	18.45 (22.97)	17.47 (23.51)	12.69 (19.68)
Change at Week 16:Domain 2	9.80 (18.40)	17.14 (21.58)	15.48 (22.71)	11.80 (19.21)
Baseline: Domain 3	43.62 (25.48)	44.21 (26.10)	46.50 (23.89)	45.44 (25.54)
Change at Week 12:Domain 3	10.77 (22.74)	20.00 (26.45)	17.57 (25.61)	13.03 (24.97)
Change at Week 16:Domain 3	10.05 (22.09)	19.04 (26.83)	17.23 (24.53)	12.59 (23.53)
Baseline: Domain 4	33.72 (17.09)	33.65 (16.04)	33.72 (14.85)	34.02 (16.74)
Change at Week 12:Domain 4	13.67 (20.32)	23.08 (23.15)	21.07 (23.88)	14.93 (20.47)
Change at Week 16:Domain 4	11.53 (18.48)	21.16 (22.93)	19.19 (22.71)	14.50 (21.46)
Baseline: Domain 5	53.09 (20.63)	51.00 (21.81)	52.32 (18.93)	51.84 (20.54)
Change at Week 12:Domain 5	4.39 (12.54)	10.29 (18.21)	6.96 (16.19)	7.19 (14.89)
Change at Week 16:Domain 5	4.36 (14.22)	9.20 (17.50)	8.35 (15.53)	6.22 (15.43)
Baseline: Domain 6	69.28 (27.86)	68.53 (26.43)	69.86 (25.08)	67.94 (25.48)
Change at Week 12:Domain 6	9.05 (21.02)	11.82 (25.32)	8.48 (21.71)	9.44 (20.84)
Change at Week 16:Domain 6	7.29 (20.84)	12.13 (25.06)	8.79 (20.15)	8.81 (23.57)
Baseline: Domain 7	70.69 (32.12)	71.52 (29.63)	72.94 (27.16)	71.54 (29.22)
Change at Week 12:Domain 7	6.03 (19.98)	9.00 (26.96)	6.06 (18.70)	4.88 (24.57)
Change at Week 16:Domain 7	4.90 (23.69)	8.91 (24.12)	5.57 (20.13)	4.92 (23.06)
Baseline: Domain 8	76.06 (18.01)	75.80 (17.76)	74.48 (17.95)	74.91 (17.79)
Change at Week 12:Domain 8	2.94 (11.39)	3.46 (16.38)	3.66 (12.94)	2.56 (13.50)
Change at Week 16:Domain 8	1.93 (14.36)	3.21 (15.72)	3.56 (13.42)	2.59 (13.78)
Baseline: MCA	0.31 (1.27)	0.26 (1.21)	0.25 (1.15)	0.24 (1.21)
Change at Week 12: MCA	0.15 (0.70)	0.16 (1.03)	0.07 (0.76)	0.11 (0.84)
Change at Week 16: MCA	0.10 (0.83)	0.17 (0.95)	0.10 (0.76)	0.11 (0.90)
Baseline: PCA	-1.92 (0.74)	-1.85 (0.76)	-1.78 (0.72)	-1.86 (0.78)
Change at Week 12: PCA	0.47 (0.74)	0.88 (0.90)	0.77 (0.93)	0.59 (0.80)
Change at Week 16: PCA	0.45 (0.74)	0.80 (0.88)	0.73 (0.88)	0.56 (0.82)

30. 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 the study drug.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	208	206	208	206
Median (Full Range) [days]	NA	NA	NA	NA

31. 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 in a 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	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Week 2	62.5 30%	47.3 23%	58.6 28.2%	49.7 24.1%
Week 4	59.5 28.6%	35.3 17.1%	38.9 18.7%	47.0 22.8%
Week 8	53.5 25.7%	35.8 17.4%	33.0 15.9%	40.0 19.4%
Week 12	42.5 20.4%	29.4 14.3%	30.5 14.7%	32.0 15.5%
Week 16	40.5 19.5%	26.9 13.1%	25.1 12.1%	36.0 17.5%

32. Secondary Outcome

Title	Number of Days Participants Used Rescue Medication
Description	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a 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	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Week 2	1	0	1	0
Week 4	1	0	0	0
Week 8	1	0	0	0
Week 12	0	0	0	0
Week 16	0	0	0	0

33. 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 in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.
Time Frame	Week 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	200	202	203	200
Week 2	3512.50 (5086.79)	2644.28 (4867.40)	2546.80 (3691.91)	2025.13 (3468.75)
Week 4	3492.50 (5755.81)	1773.63 (3849.64)	1795.57 (4134.95)	2210.00 (3887.99)
Week 8	3320.00 (5384.01)	1684.08 (3506.56)	1423.65 (3833.84)	1987.50 (3967.02)
Week 12	2857.50 (5617.94)	1238.81 (3024.10)	1504.93 (4054.39)	1800.00 (4034.40)
Week 16	2860.00 (5948.73)	1427.86 (3733.77)	1458.13 (4081.41)	1872.50 (3967.52)

34. Other Pre-specified 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	Day 1 (Baseline) up to Week 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of the study drug.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	208	206	208	206
Adverse Events	99 47.6%	107 51.9%	122 58.7%	104 50.5%
Serious Adverse Events	8 3.8%	7 3.4%	6 2.9%	5 2.4%

35. Other Pre-specified Outcome

Title	Number of Participants With Laboratory Test Abnormalities
Description	Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;cholesterol,triglycerides>1.3*ULN;sodium <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN,phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLN or >1.5*ULN,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).
Time Frame	Day 1 (Baseline) up to Week 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of the study drug. Here, 'N' signifies number of participants 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	203	203	202	205
Count of Participants [Participants]	146 70.2%	155 75.2%	139 66.8%	162 78.6%

36. Other Pre-specified Outcome

Title	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Description	Criteria for potential clinical concern in ECG parameters are: Criterion 1= maximum QTcB interval (Bazett's correction) in range of 450 millisecond (msec) to less than 480 msec, Criterion 2= maximum QTcB interval in range of 480 msec to less than 500 msec, Criterion 3= maximum QTcB interval >= 500 msec; Criterion 4= maximum QTcF interval (Fridericia's correction) in range of 450 msec to less than 480 msec, Criterion 5= maximum QTcF interval in range of 480 msec to less than 500 msec, Criterion 6= maximum QTcF interval >= 500 msec, Criterion 7= maximum QTcB interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 8= maximum QTcB interval increase >=60 msec, Criterion 9= maximum QTcF interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 10= maximum QTcF interval increase >=60 msec.
Time Frame	Day 1 (Baseline) up to Week 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	208	206	208	206
Criterion 1	35 16.8%	39 18.9%	38 18.3%	45 21.8%
Criterion 2	8 3.8%	3 1.5%	5 2.4%	1 0.5%
Criterion 3	1 0.5%	0 0%	3 1.4%	1 0.5%
Criterion 4	13 6.3%	16 7.8%	13 6.3%	9 4.4%
Criterion 5	1 0.5%	3 1.5%	2 1%	2 1%
Criterion 6	1 0.5%	0 0%	2 1%	0 0%
Criterion 7	29 13.9%	25 12.1%	28 13.5%	27 13.1%
Criterion 8	2 1%	2 1%	3 1.4%	1 0.5%
Criterion 9	13 6.3%	18 8.7%	21 10.1%	21 10.2%
Criterion 10	2 1%	1 0.5%	1 0.5%	1 0.5%

37. Other Pre-specified Outcome

Title	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 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 from both the left and right side, 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 244 (maximum impairment), higher scores indicate increased impairment.
Time Frame	Baseline, Week 2, 4, 8, 12, 16, 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of the study drug. LOCF 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 (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	208	206	208	206
Baseline	1.55 (3.45)	1.75 (3.90)	1.14 (3.32)	1.43 (3.23)
Change at Week 2	-0.14 (1.34)	-0.37 (2.49)	0.14 (2.28)	-0.20 (1.65)
Change at Week 4	-0.02 (1.78)	-0.50 (2.70)	-0.16 (2.20)	-0.25 (1.71)
Change at Week 8	-0.12 (2.14)	-0.51 (2.58)	-0.00 (2.71)	-0.27 (1.40)
Change at Week 12	-0.17 (1.88)	-0.42 (2.53)	-0.12 (2.67)	-0.25 (1.58)
Change at Week 16	-0.11 (1.70)	-0.50 (2.53)	-0.21 (2.69)	-0.34 (1.73)
Change at Week 24	-0.13 (1.75)	-0.51 (2.50)	-0.21 (2.69)	-0.34 (1.70)

38. Other Pre-specified 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, Week 8, 16, 24

Outcome Measure Data

Analysis Population Description

Analysis set included all randomized participants who received at least 1 dose of the study drug. 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 (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.
Measure Participants	206	208
Baseline	1 0.5%	1 0.5%
Week 8	1 0.5%	0 0%
Week 16	0 0%	0 0%
Week 24	1 0.5%	1 0.5%

39. Other Pre-specified Outcome

Title	Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities
Description	Assessment of the clinical significance of vital sign changes was done per investigator judgment. Changes in vital signs determined to be clinically significant by the investigator were reported as adverse events.
Time Frame	Day 1 (Baseline) up to Week 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of the study drug.

Arm/Group Title	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.
Measure Participants	208	206	208	206
Count of Participants [Participants]	2 1%	0 0%	2 1%	3 1.5%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. ITT analysis set evaluated for safety.
Arm/Group Title	Placebo		Tanezumab 5 mg + Placebo		Tanezumab 10 mg + Placebo		Naproxen + Placebo
Arm/Group Description	Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.		Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.		Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.		Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at 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	8/208 (3.8%)		7/206 (3.4%)		6/208 (2.9%)		5/206 (2.4%)
Cardiac disorders
Angina pectoris	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Atrial fibrillation	0/208 (0%)		0/206 (0%)		0/208 (0%)		1/206 (0.5%)
Atrioventricular block complete	0/208 (0%)		1/206 (0.5%)		0/208 (0%)		0/206 (0%)
Cardiac arrest	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Cardiac failure congestive	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Coronary artery stenosis	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Mitral valve incompetence	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Ear and labyrinth disorders
Vertigo	0/208 (0%)		0/206 (0%)		1/208 (0.5%)		0/206 (0%)
Gastrointestinal disorders
Constipation	0/208 (0%)		0/206 (0%)		0/208 (0%)		1/206 (0.5%)
Intestinal obstruction	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Pancreatitis acute	0/208 (0%)		0/206 (0%)		1/208 (0.5%)		0/206 (0%)
General disorders
Chest pain	0/208 (0%)		0/206 (0%)		0/208 (0%)		1/206 (0.5%)
Infections and infestations
Cellulitis	0/208 (0%)		0/206 (0%)		1/208 (0.5%)		0/206 (0%)
Diverticulitis	0/208 (0%)		0/206 (0%)		0/208 (0%)		1/206 (0.5%)
Pneumonia	1/208 (0.5%)		0/206 (0%)		1/208 (0.5%)		0/206 (0%)
Upper respiratory tract infection	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Injury, poisoning and procedural complications
Ankle fracture	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Collapse of lung	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Post concussion syndrome	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Subdural haematoma	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Thoracic vertebral fracture	0/208 (0%)		0/206 (0%)		1/208 (0.5%)		0/206 (0%)
Traumatic brain injury	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Musculoskeletal and connective tissue disorders
Muscular weakness	0/208 (0%)		0/206 (0%)		0/208 (0%)		1/206 (0.5%)
Osteoarthritis	0/208 (0%)		1/206 (0.5%)		0/208 (0%)		0/206 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/208 (0%)		1/206 (0.5%)		2/208 (1%)		0/206 (0%)
Metastatic neoplasm	0/208 (0%)		0/206 (0%)		0/208 (0%)		1/206 (0.5%)
Neoplasm malignant	0/208 (0%)		0/206 (0%)		0/208 (0%)		1/206 (0.5%)
Prostate cancer	0/208 (0%)		1/206 (0.5%)		0/208 (0%)		0/206 (0%)
Thyroid cancer	0/208 (0%)		1/206 (0.5%)		0/208 (0%)		0/206 (0%)
Nervous system disorders
Haemorrhagic stroke	0/208 (0%)		0/206 (0%)		1/208 (0.5%)		0/206 (0%)
Hypoaesthesia	0/208 (0%)		0/206 (0%)		0/208 (0%)		1/206 (0.5%)
Subarachnoid haemorrhage	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Renal and urinary disorders
Calculus ureteric	0/208 (0%)		1/206 (0.5%)		0/208 (0%)		0/206 (0%)
Renal failure acute	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/208 (0.5%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Asthma	2/208 (1%)		0/206 (0%)		0/208 (0%)		0/206 (0%)
Chronic obstructive pulmonary disease	0/208 (0%)		0/206 (0%)		0/208 (0%)		1/206 (0.5%)
Obstructive airways disorder	0/208 (0%)		0/206 (0%)		1/208 (0.5%)		0/206 (0%)
Vascular disorders
Hypertension	0/208 (0%)		1/206 (0.5%)		0/208 (0%)		0/206 (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	59/208 (28.4%)		70/206 (34%)		92/208 (44.2%)		68/206 (33%)
Gastrointestinal disorders
Constipation	0/208 (0%)		1/206 (0.5%)		1/208 (0.5%)		6/206 (2.9%)
Nausea	4/208 (1.9%)		4/206 (1.9%)		4/208 (1.9%)		6/206 (2.9%)
General disorders
Oedema peripheral	0/208 (0%)		9/206 (4.4%)		15/208 (7.2%)		4/206 (1.9%)
Infections and infestations
Bronchitis	5/208 (2.4%)		0/206 (0%)		3/208 (1.4%)		4/206 (1.9%)
Influenza	4/208 (1.9%)		0/206 (0%)		5/208 (2.4%)		3/206 (1.5%)
Nasopharyngitis	4/208 (1.9%)		2/206 (1%)		6/208 (2.9%)		8/206 (3.9%)
Sinusitis	10/208 (4.8%)		6/206 (2.9%)		6/208 (2.9%)		7/206 (3.4%)
Upper respiratory tract infection	9/208 (4.3%)		12/206 (5.8%)		6/208 (2.9%)		4/206 (1.9%)
Urinary tract infection	2/208 (1%)		6/206 (2.9%)		7/208 (3.4%)		7/206 (3.4%)
Injury, poisoning and procedural complications
Fall	8/208 (3.8%)		5/206 (2.4%)		2/208 (1%)		2/206 (1%)
Investigations
Blood creatine phosphokinase increased	0/208 (0%)		8/206 (3.9%)		3/208 (1.4%)		4/206 (1.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	8/208 (3.8%)		12/206 (5.8%)		14/208 (6.7%)		6/206 (2.9%)
Back pain	4/208 (1.9%)		5/206 (2.4%)		3/208 (1.4%)		7/206 (3.4%)
Joint swelling	1/208 (0.5%)		7/206 (3.4%)		8/208 (3.8%)		5/206 (2.4%)
Muscle spasms	2/208 (1%)		4/206 (1.9%)		5/208 (2.4%)		2/206 (1%)
Pain in extremity	6/208 (2.9%)		6/206 (2.9%)		20/208 (9.6%)		1/206 (0.5%)
Nervous system disorders
Allodynia	0/208 (0%)		0/206 (0%)		5/208 (2.4%)		0/206 (0%)
Carpal tunnel syndrome	0/208 (0%)		3/206 (1.5%)		5/208 (2.4%)		0/206 (0%)
Dizziness	5/208 (2.4%)		6/206 (2.9%)		0/208 (0%)		3/206 (1.5%)
Headache	11/208 (5.3%)		7/206 (3.4%)		5/208 (2.4%)		9/206 (4.4%)
Hypoaesthesia	2/208 (1%)		4/206 (1.9%)		10/208 (4.8%)		7/206 (3.4%)
Paraesthesia	3/208 (1.4%)		12/206 (5.8%)		18/208 (8.7%)		6/206 (2.9%)
Skin and subcutaneous tissue disorders
Pruritus	0/208 (0%)		3/206 (1.5%)		5/208 (2.4%)		0/206 (0%)

Limitations/Caveats

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

Restriction Description: 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.