Tanezumab in Osteoarthritis of the Knee

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00733902

Enrollment

697

Registered

2008-08-13

Start date

2008-09-15

Completion date

2010-01-14

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Osteoarthritis

Keywords

monoclonal antibody, RN624, PF-04383119, nerve growth factor, anti-nerve growth factor, OA, pain

Brief summary

Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.

Interventions

BIOLOGICALtanezumab

IV tanezumab 10 mg at 1 dose every 8 weeks

BIOLOGICALPlacebo

IV placebo to match tanezumab at 1 dose every 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2. * Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery. * Pain level and function levels as required by the protocol at Screening and Baseline. * Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study. * Must agree to the contraceptive requirements of the protocol if applicable. * Must agree to the treatment plan, scheduled visits, and procedures of the protocol.

Exclusion criteria

* Pregnancy or intent to become pregnant during the study * BMI greater than 39 * other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results

Design outcomes

Primary

Measure	Time frame	Description
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 for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 16	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 16	Participants answered: Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?. Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.

Secondary

Measure	Time frame	Description
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 24	Participants answered: Considering all the ways your osteoarthritis in your knee affects you, how are you doing today. Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	Participants answered: Considering all the ways your osteoarthritis in your knee affects you, how are you doing today. Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 2, 4, 8, 12, 16, 24	OMERACT-OARSI response: greater than or equal to (\>=) 50 percent (%) improvement from baseline and absolute change from baseline of \>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 2, 4, 8, 12, 16, 24	OMERACT-OARSI response: \>= 50% improvement from baseline and absolute change from baseline of \>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
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, 24	Participants answered: Considering all the ways your osteoarthritis in your knee affects you, how are you doing today. Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
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, 24	Participants answered: Considering all the ways your osteoarthritis in your knee affects you, how are you doing today. Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 24	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Baseline up to Week 16	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported.
Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24	Participants assessed daily average knee pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Baseline score was calculated as the mean of the scores over the 3 days and a weekly mean was calculated using the daily pain scores within each study week. The change from Baseline was calculated using difference between each post-baseline weekly mean and the Baseline mean score.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	Participants answered, Question (Q)1: How much pain have you had when walking on a flat surface? and Q2: How much pain have you had when going up or down the stairs?. Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 12, 24	SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 12, 24	SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition. For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States \[US\] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score \[better functioning\])/lower (in case of negative z-score \[worse functioning\]) participant's value was relative to the mean of the reference population.
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.
Percentage of Participants Who Used Rescue Medications	Week 2, 4, 8, 12, 16, 24	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication.
Duration of Rescue Medication Use	Week 2, 4, 8, 12, 16, 24	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication.
Amount of Rescue Medication Taken	Week 2, 4, 8, 12, 16, 24	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication.
Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Baseline up to Week 16	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 24	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living

Countries

United States

Participant flow

Pre-assignment details

Participants who discontinued due to lack of efficacy or completed the treatment in this study were eligible to enroll in safety extension study A4091016 (NCT00809783).

Participants by arm

Arm	Count
Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	172
Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	172
Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	172
Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	174
Total	690

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	3	4	7	11
Overall Study	Death	0	0	0	1
Overall Study	Entered extension study	89	124	111	109
Overall Study	Lack of Efficacy	56	21	34	23
Overall Study	Protocol Violation	4	6	3	3
Overall Study	Randomized but not treated	2	2	2	1
Overall Study	Withdrawal by Subject	10	5	4	16

Baseline characteristics

Characteristic	Placebo	Tanezumab 2.5 mg	Tanezumab 5 mg	Tanezumab 10 mg	Total
Age, Continuous	62.2 years STANDARD_DEVIATION 9.9	60.8 years STANDARD_DEVIATION 9.8	62.1 years STANDARD_DEVIATION 10.5	61.4 years STANDARD_DEVIATION 10.5	61.6 years STANDARD_DEVIATION 10.2
Sex: Female, Male Female	119 Participants	94 Participants	101 Participants	106 Participants	420 Participants
Sex: Female, Male Male	53 Participants	78 Participants	71 Participants	68 Participants	270 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	50 / 172	71 / 172	64 / 172	87 / 174
serious Total, serious adverse events	3 / 172	3 / 172	4 / 172	3 / 174

Outcome results

Primary

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

Participants answered: Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?. Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.

Time frame: Baseline, Week 16

Population: mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.40 units on a scale	Standard Deviation 0.58
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-0.51 units on a scale	Standard Deviation 0.83
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-0.87 units on a scale	Standard Deviation 0.93
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.47 units on a scale	Standard Deviation 0.63
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.45 units on a scale	Standard Deviation 0.63
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-0.91 units on a scale	Standard Deviation 0.95
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.45 units on a scale	Standard Deviation 0.59
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.05 units on a scale	Standard Deviation 1.06

Comparison: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00195% CI: [-0.52, -0.13]ANCOVA

Comparison: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.56, -0.17]ANCOVA

Comparison: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.7, -0.31]ANCOVA

Primary

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

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

Time frame: Baseline (Day 1), Week 16

Population: Modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.05 units on a scale	Standard Deviation 1.45
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.51 units on a scale	Standard Deviation 2.63
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.27 units on a scale	Standard Deviation 2.78
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.16 units on a scale	Standard Deviation 1.44
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.19 units on a scale	Standard Deviation 1.41
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.39 units on a scale	Standard Deviation 2.65
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.99 units on a scale	Standard Deviation 1.43
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.67 units on a scale	Standard Deviation 2.83

Comparison: Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.01595% CI: [-1.32, -0.14]ANCOVA

Comparison: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00595% CI: [-1.43, -0.25]ANCOVA

Comparison: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.78, -0.61]ANCOVA

Primary

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme 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

Population: mITT analysis set. BOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.64 units on a scale	Standard Deviation 1.59
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.06 units on a scale	Standard Deviation 2.45
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.93 units on a scale	Standard Deviation 2.67
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.86 units on a scale	Standard Deviation 1.58
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.91 units on a scale	Standard Deviation 1.49
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.14 units on a scale	Standard Deviation 2.59
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.69 units on a scale	Standard Deviation 1.62
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.34 units on a scale	Standard Deviation 2.7

Comparison: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00995% CI: [-1.32, -0.19]ANCOVA

Comparison: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.54, -0.41]ANCOVA

Comparison: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.8, -0.68]ANCOVA

Secondary

Amount of Rescue Medication Taken

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication.

Time frame: Week 2, 4, 8, 12, 16, 24

Population: mITT analysis set. LOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Amount of Rescue Medication Taken	Week 2	3493.51 mg/week	Standard Deviation 4969.51
Placebo	Amount of Rescue Medication Taken	Week 4	2691.56 mg/week	Standard Deviation 4484.61
Placebo	Amount of Rescue Medication Taken	Week 8	2383.12 mg/week	Standard Deviation 4292.72
Placebo	Amount of Rescue Medication Taken	Week 12	1941.56 mg/week	Standard Deviation 4184.45
Placebo	Amount of Rescue Medication Taken	Week 16	2058.44 mg/week	Standard Deviation 4440.22
Placebo	Amount of Rescue Medication Taken	Week 24	1704.55 mg/week	Standard Deviation 4183.54
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 24	1879.87 mg/week	Standard Deviation 4351.79
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 12	1788.96 mg/week	Standard Deviation 4455.58
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 2	2818.18 mg/week	Standard Deviation 4063.15
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 8	2133.12 mg/week	Standard Deviation 4199.69
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 4	1925.32 mg/week	Standard Deviation 3943.13
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 16	2207.79 mg/week	Standard Deviation 4696.58
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 4	1891.03 mg/week	Standard Deviation 4038.24
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 8	1753.21 mg/week	Standard Deviation 4109.59
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 12	1567.31 mg/week	Standard Deviation 4359.67
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 24	1836.54 mg/week	Standard Deviation 4768.57
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 16	1820.51 mg/week	Standard Deviation 4615.52
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 2	3419.87 mg/week	Standard Deviation 4759.2
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 16	1663.40 mg/week	Standard Deviation 4367.5
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 24	1588.24 mg/week	Standard Deviation 4443.03
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 4	2065.36 mg/week	Standard Deviation 4510.11
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 12	1977.12 mg/week	Standard Deviation 6122.2
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 2	2993.46 mg/week	Standard Deviation 4226.71
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 8	1934.64 mg/week	Standard Deviation 4568.45

Secondary

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)

Time frame: Baseline, Week 12, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Vitality	51.42 units on a scale	Standard Deviation 19.22
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Physical	7.75 units on a scale	Standard Deviation 22.97
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Bodily Pain	11.68 units on a scale	Standard Deviation 21.15
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Vitality	3.21 units on a scale	Standard Deviation 14.4
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Function	32.64 units on a scale	Standard Deviation 19.16
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Social Function	4.95 units on a scale	Standard Deviation 22.62
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Social Function	69.48 units on a scale	Standard Deviation 25.53
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Emotional	4.44 units on a scale	Standard Deviation 20.08
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Health	2.21 units on a scale	Standard Deviation 12.3
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Emotional	73.43 units on a scale	Standard Deviation 27.13
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Health	74.35 units on a scale	Standard Deviation 16.18
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: General health	3.28 units on a scale	Standard Deviation 12.12
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Physical	45.74 units on a scale	Standard Deviation 25.76
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Physical Function	8.26 units on a scale	Standard Deviation 18.75
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Physical	8.97 units on a scale	Standard Deviation 24.21
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Bodily Pain	11.83 units on a scale	Standard Deviation 19.6
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Vitality	4.34 units on a scale	Standard Deviation 14.62
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Bodily Pain	34.48 units on a scale	Standard Deviation 15.6
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Social Function	6.25 units on a scale	Standard Deviation 22.2
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Emotional	5.30 units on a scale	Standard Deviation 21.28
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Health	3.80 units on a scale	Standard Deviation 13.59
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: General health	3.38 units on a scale	Standard Deviation 11.81
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: General health	67.16 units on a scale	Standard Deviation 18.72
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Physical Function	8.75 units on a scale	Standard Deviation 19.53
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Function	30.52 units on a scale	Standard Deviation 20.07
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Emotional	67.48 units on a scale	Standard Deviation 29.88
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Emotional	10.71 units on a scale	Standard Deviation 26.47
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Health	75.49 units on a scale	Standard Deviation 18.23
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: General health	65.39 units on a scale	Standard Deviation 17.74
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: General health	3.62 units on a scale	Standard Deviation 11.81
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Physical Function	15.25 units on a scale	Standard Deviation 20.98
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Physical Function	19.99 units on a scale	Standard Deviation 22.43
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Physical	42.25 units on a scale	Standard Deviation 24.41
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Health	3.41 units on a scale	Standard Deviation 14.08
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Physical	19.85 units on a scale	Standard Deviation 27.5
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Bodily Pain	22.46 units on a scale	Standard Deviation 25.53
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Physical	14.12 units on a scale	Standard Deviation 26.73
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Vitality	54.26 units on a scale	Standard Deviation 18.62
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Vitality	6.94 units on a scale	Standard Deviation 16.16
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Bodily Pain	15.34 units on a scale	Standard Deviation 24.39
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Vitality	4.79 units on a scale	Standard Deviation 15.75
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: General health	4.27 units on a scale	Standard Deviation 11.87
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Social Function	6.98 units on a scale	Standard Deviation 25.53
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Social Function	10.96 units on a scale	Standard Deviation 25.7
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Emotional	7.58 units on a scale	Standard Deviation 23.56
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Social Function	68.91 units on a scale	Standard Deviation 27.28
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Bodily Pain	33.84 units on a scale	Standard Deviation 17.5
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Health	1.23 units on a scale	Standard Deviation 14.39
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: General health	65.99 units on a scale	Standard Deviation 17.82
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: General health	3.31 units on a scale	Standard Deviation 13.1
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Bodily Pain	33.50 units on a scale	Standard Deviation 16.28
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Emotional	71.85 units on a scale	Standard Deviation 28.29
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Function	30.46 units on a scale	Standard Deviation 19.11
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Physical Function	13.54 units on a scale	Standard Deviation 23
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Physical	12.82 units on a scale	Standard Deviation 23.51
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Health	76.44 units on a scale	Standard Deviation 16.86
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Health	2.31 units on a scale	Standard Deviation 13.24
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Emotional	8.81 units on a scale	Standard Deviation 23.95
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Emotional	6.41 units on a scale	Standard Deviation 22.18
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: General health	5.81 units on a scale	Standard Deviation 14.17
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Social Function	7.69 units on a scale	Standard Deviation 21.65
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Social Function	70.03 units on a scale	Standard Deviation 25.59
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Bodily Pain	14.23 units on a scale	Standard Deviation 22.96
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Physical Function	18.12 units on a scale	Standard Deviation 22.72
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Vitality	55.25 units on a scale	Standard Deviation 18.27
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Vitality	6.69 units on a scale	Standard Deviation 18.58
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Social Function	11.46 units on a scale	Standard Deviation 21.15
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Physical	19.51 units on a scale	Standard Deviation 25.54
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Physical	43.51 units on a scale	Standard Deviation 24.39
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Health	4.17 units on a scale	Standard Deviation 15.91
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Vitality	3.17 units on a scale	Standard Deviation 14.8
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Bodily Pain	21.19 units on a scale	Standard Deviation 23.77
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Emotional	10.50 units on a scale	Standard Deviation 28.26
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: General health	69.38 units on a scale	Standard Deviation 17.47
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Function	33.42 units on a scale	Standard Deviation 20.9
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Physical	45.33 units on a scale	Standard Deviation 27.98
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Bodily Pain	34.20 units on a scale	Standard Deviation 16.06
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Vitality	53.45 units on a scale	Standard Deviation 21.43
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Social Function	72.65 units on a scale	Standard Deviation 24.58
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Emotional	71.37 units on a scale	Standard Deviation 30.19
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Health	76.36 units on a scale	Standard Deviation 17.42
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: General health	5.11 units on a scale	Standard Deviation 13.44
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Physical Function	19.34 units on a scale	Standard Deviation 22.36
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Physical	18.06 units on a scale	Standard Deviation 25.56
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Bodily Pain	24.36 units on a scale	Standard Deviation 24.62
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Vitality	9.28 units on a scale	Standard Deviation 17.04
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Social Function	7.47 units on a scale	Standard Deviation 22.44
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Health	3.77 units on a scale	Standard Deviation 14.02
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: General health	2.94 units on a scale	Standard Deviation 10.2
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Physical Function	17.97 units on a scale	Standard Deviation 23.32
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Physical	17.21 units on a scale	Standard Deviation 25.35
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Bodily Pain	19.02 units on a scale	Standard Deviation 24.36
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Vitality	5.68 units on a scale	Standard Deviation 14.56
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Social Function	7.87 units on a scale	Standard Deviation 18.02
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Emotional	10.44 units on a scale	Standard Deviation 25.25
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Health	2.11 units on a scale	Standard Deviation 13.88

Secondary

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)

SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition. For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States \[US\] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score \[better functioning\])/lower (in case of negative z-score \[worse functioning\]) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Week 12, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Component Aggregate	0.23 z-score	Standard Deviation 1.08
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Component Aggregate	-1.79 z-score	Standard Deviation 0.77
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Component Aggregate	0.16 z-score	Standard Deviation 0.83
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Physical Component Aggregate	0.37 z-score	Standard Deviation 0.78
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Component Aggregate	0.07 z-score	Standard Deviation 0.73
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Physical Component Aggregate	0.38 z-score	Standard Deviation 0.8
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Physical Component Aggregate	0.63 z-score	Standard Deviation 0.89
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Physical Component Aggregate	0.82 z-score	Standard Deviation 0.95
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Component Aggregate	0.21 z-score	Standard Deviation 1.17
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Component Aggregate	0.13 z-score	Standard Deviation 0.98
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Component Aggregate	-1.86 z-score	Standard Deviation 0.73
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Component Aggregate	0.04 z-score	Standard Deviation 0.94
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Component Aggregate	-1.89 z-score	Standard Deviation 0.72
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Component Aggregate	0.14 z-score	Standard Deviation 0.94
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Physical Component Aggregate	0.80 z-score	Standard Deviation 0.88
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Physical Component Aggregate	0.55 z-score	Standard Deviation 0.87
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Component Aggregate	0.06 z-score	Standard Deviation 0.8
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Component Aggregate	0.34 z-score	Standard Deviation 1.11
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Component Aggregate	0.09 z-score	Standard Deviation 0.83
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Physical Component Aggregate	0.72 z-score	Standard Deviation 0.9
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Component Aggregate	-1.76 z-score	Standard Deviation 0.76
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Physical Component Aggregate	0.83 z-score	Standard Deviation 0.85
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Component Aggregate	0.30 z-score	Standard Deviation 1.11
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Component Aggregate	0.11 z-score	Standard Deviation 0.9

Secondary

Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)

Participants assessed daily average knee pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Baseline score was calculated as the mean of the scores over the 3 days and a weekly mean was calculated using the daily pain scores within each study week. The change from Baseline was calculated using difference between each post-baseline weekly mean and the Baseline mean score.

Time frame: Baseline, Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24

Population: mITT analysis set. BOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.73 units on a scale	Standard Deviation 2.34
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-1.63 units on a scale	Standard Deviation 2.21
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 10	-1.84 units on a scale	Standard Deviation 2.41
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.38 units on a scale	Standard Deviation 1.93
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.82 units on a scale	Standard Deviation 2.37
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.68 units on a scale	Standard Deviation 2.21
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 3	-1.73 units on a scale	Standard Deviation 2.22
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 1	-1.21 units on a scale	Standard Deviation 1.97
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 20	-1.80 units on a scale	Standard Deviation 2.3
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.81 units on a scale	Standard Deviation 2.32
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 6	-1.83 units on a scale	Standard Deviation 2.37
Placebo	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.67 units on a scale	Standard Deviation 2.28
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 1	-1.87 units on a scale	Standard Deviation 2.04
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.45 units on a scale	Standard Deviation 2.61
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 3	-2.38 units on a scale	Standard Deviation 2.52
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.91 units on a scale	Standard Deviation 2.76
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.28 units on a scale	Standard Deviation 2.69
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 10	-2.80 units on a scale	Standard Deviation 2.76
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.70 units on a scale	Standard Deviation 1.83
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 6	-2.78 units on a scale	Standard Deviation 2.66
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.73 units on a scale	Standard Deviation 2.49
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.12 units on a scale	Standard Deviation 2.42
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.44 units on a scale	Standard Deviation 2.78
Tanezumab 2.5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 20	-2.80 units on a scale	Standard Deviation 2.88
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 10	-2.65 units on a scale	Standard Deviation 2.4
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.74 units on a scale	Standard Deviation 1.63
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 1	-1.83 units on a scale	Standard Deviation 1.84
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.83 units on a scale	Standard Deviation 2.02
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 3	-1.90 units on a scale	Standard Deviation 2.06
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.47 units on a scale	Standard Deviation 2.14
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 6	-2.50 units on a scale	Standard Deviation 2.2
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.47 units on a scale	Standard Deviation 2.18
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.78 units on a scale	Standard Deviation 2.52
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.58 units on a scale	Standard Deviation 2.47
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 20	-2.81 units on a scale	Standard Deviation 2.54
Tanezumab 5 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.29 units on a scale	Standard Deviation 2.48
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 6	-3.07 units on a scale	Standard Deviation 2.59
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.99 units on a scale	Standard Deviation 2.52
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.55 units on a scale	Standard Deviation 1.91
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.15 units on a scale	Standard Deviation 2.76
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 3	-2.17 units on a scale	Standard Deviation 2.47
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.15 units on a scale	Standard Deviation 2.31
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.98 units on a scale	Standard Deviation 2.93
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 20	-3.27 units on a scale	Standard Deviation 2.83
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 10	-3.33 units on a scale	Standard Deviation 2.82
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.10 units on a scale	Standard Deviation 2.63
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 1	-2.09 units on a scale	Standard Deviation 2.03
Tanezumab 10 mg	Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.27 units on a scale	Standard Deviation 2.72

Secondary

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)

Participants answered: Considering all the ways your osteoarthritis in your knee affects you, how are you doing today. Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	3.40 units on a scale	Standard Deviation 0.58
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.58 units on a scale	Standard Deviation 0.91
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-0.60 units on a scale	Standard Deviation 0.88
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.55 units on a scale	Standard Deviation 0.87
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-0.60 units on a scale	Standard Deviation 0.92
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-0.57 units on a scale	Standard Deviation 0.83
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.47 units on a scale	Standard Deviation 0.79
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.90 units on a scale	Standard Deviation 0.93
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.86 units on a scale	Standard Deviation 0.9
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.08 units on a scale	Standard Deviation 0.91
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-1.05 units on a scale	Standard Deviation 0.97
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-0.82 units on a scale	Standard Deviation 0.9
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.91 units on a scale	Standard Deviation 0.9
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	3.47 units on a scale	Standard Deviation 0.63
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.90 units on a scale	Standard Deviation 0.92
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	3.45 units on a scale	Standard Deviation 0.63
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.63 units on a scale	Standard Deviation 0.88
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.05 units on a scale	Standard Deviation 0.91
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-0.99 units on a scale	Standard Deviation 0.9
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.97 units on a scale	Standard Deviation 0.96
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-0.82 units on a scale	Standard Deviation 1
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.18 units on a scale	Standard Deviation 1
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-1.13 units on a scale	Standard Deviation 1.12
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-1.19 units on a scale	Standard Deviation 1.05
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.82 units on a scale	Standard Deviation 0.99
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	3.45 units on a scale	Standard Deviation 0.59
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-1.28 units on a scale	Standard Deviation 1.03
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-1.21 units on a scale	Standard Deviation 0.98

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.49, -0.14]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.48695% CI: [-0.24, 0.11]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00895% CI: [-0.42, -0.06]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.64, -0.28]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.62, -0.26]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.75, -0.39]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.53, -0.16]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.58, -0.22]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.89, -0.52]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.59, -0.22]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.55, -0.18]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.83, -0.46]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00495% CI: [-0.47, -0.09]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.55, -0.17]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.77, -0.39]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.0995% CI: [-0.37, 0.03]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.05395% CI: [-0.39, 0]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.7, -0.3]ANCOVA

Secondary

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)

Time frame: Baseline, Week 2, 4, 8, 12, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-0.53 units on a scale	Standard Deviation 0.82
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-0.55 units on a scale	Standard Deviation 0.78
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-0.53 units on a scale	Standard Deviation 0.83
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.46 units on a scale	Standard Deviation 0.73
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.55 units on a scale	Standard Deviation 0.87
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.84 units on a scale	Standard Deviation 0.9
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.01 units on a scale	Standard Deviation 0.98
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-0.77 units on a scale	Standard Deviation 0.9
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.04 units on a scale	Standard Deviation 0.92
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.91 units on a scale	Standard Deviation 0.9
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.84 units on a scale	Standard Deviation 0.91
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.63 units on a scale	Standard Deviation 0.88
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.04 units on a scale	Standard Deviation 0.91
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-0.94 units on a scale	Standard Deviation 0.89
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-0.70 units on a scale	Standard Deviation 0.94
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.17 units on a scale	Standard Deviation 1.03
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.16 units on a scale	Standard Deviation 0.99
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.82 units on a scale	Standard Deviation 0.99
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.16 units on a scale	Standard Deviation 0.99
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-0.93 units on a scale	Standard Deviation 1.11

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.57, -0.19]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.8, -0.42]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.49, -0.14]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.48695% CI: [-0.24, 0.11]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00895% CI: [-0.42, -0.06]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.63, -0.26]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.64, -0.28]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.76, -0.39]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.53, -0.16]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.54, -0.17]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.85, -0.49]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.63, -0.25]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.03595% CI: [-0.42, -0.02]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.12595% CI: [-0.36, 0.04]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.58, -0.18]ANCOVA

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.88 units on a scale	Standard Deviation 1.43
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.21 units on a scale	Standard Deviation 2.41
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.26 units on a scale	Standard Deviation 2.46
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.34 units on a scale	Standard Deviation 2.31
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.14 units on a scale	Standard Deviation 2.4
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.32 units on a scale	Standard Deviation 2.28
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.17 units on a scale	Standard Deviation 2.28
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.05 units on a scale	Standard Deviation 2.67
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.09 units on a scale	Standard Deviation 2.53
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.42 units on a scale	Standard Deviation 2.58
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.51 units on a scale	Standard Deviation 2.65
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.91 units on a scale	Standard Deviation 2.7
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.95 units on a scale	Standard Deviation 2.53
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.00 units on a scale	Standard Deviation 1.46
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.13 units on a scale	Standard Deviation 2.31
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.05 units on a scale	Standard Deviation 1.38
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.46 units on a scale	Standard Deviation 2.29
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.29 units on a scale	Standard Deviation 2.35
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.38 units on a scale	Standard Deviation 2.62
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.25 units on a scale	Standard Deviation 2.56
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.81 units on a scale	Standard Deviation 2.56
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.55 units on a scale	Standard Deviation 2.5
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-3.43 units on a scale	Standard Deviation 2.82
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.51 units on a scale	Standard Deviation 2.71
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.67 units on a scale	Standard Deviation 2.49
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.86 units on a scale	Standard Deviation 1.52
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.70 units on a scale	Standard Deviation 2.64
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.68 units on a scale	Standard Deviation 2.52

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)

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

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	7.05 units on a scale	Standard Deviation 1.45
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.89 units on a scale	Standard Deviation 2.57
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.95 units on a scale	Standard Deviation 2.51
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.75 units on a scale	Standard Deviation 2.46
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-2.93 units on a scale	Standard Deviation 2.59
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.89 units on a scale	Standard Deviation 2.44
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.65 units on a scale	Standard Deviation 2.44
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.46 units on a scale	Standard Deviation 2.69
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.44 units on a scale	Standard Deviation 2.53
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.81 units on a scale	Standard Deviation 2.57
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.96 units on a scale	Standard Deviation 2.53
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.38 units on a scale	Standard Deviation 2.72
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-3.08 units on a scale	Standard Deviation 2.55
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	7.16 units on a scale	Standard Deviation 1.44
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.44 units on a scale	Standard Deviation 2.32
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	7.19 units on a scale	Standard Deviation 1.41
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.52 units on a scale	Standard Deviation 2.39
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.45 units on a scale	Standard Deviation 2.4
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.77 units on a scale	Standard Deviation 2.56
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.60 units on a scale	Standard Deviation 2.54
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.40 units on a scale	Standard Deviation 2.57
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.82 units on a scale	Standard Deviation 2.54
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-4.11 units on a scale	Standard Deviation 2.67
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-4.17 units on a scale	Standard Deviation 2.55
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.68 units on a scale	Standard Deviation 2.56
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	6.99 units on a scale	Standard Deviation 1.43
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.13 units on a scale	Standard Deviation 2.49
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-4.01 units on a scale	Standard Deviation 2.47

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.32695% CI: [-0.8, 0.27]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.27595% CI: [-0.24, 0.83]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.91895% CI: [-0.51, 0.56]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00295% CI: [-1.39, -0.32]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.05295% CI: [-1.06, 0]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.5, -0.44]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00695% CI: [-1.26, -0.21]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00495% CI: [-1.28, -0.24]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.91, -0.86]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.5, -0.43]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00595% CI: [-1.3, -0.23]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.75, -0.69]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.06195% CI: [-1.07, 0.02]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.02195% CI: [-1.2, -0.1]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.85, -0.76]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.16695% CI: [-0.95, 0.16]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.16795% CI: [-0.95, 0.16]ANOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.75, -0.64]ANCOVA

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)

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

Time frame: Baseline, Week 2, 4, 8, 12, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.55 units on a scale	Standard Deviation 2.59
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.72 units on a scale	Standard Deviation 2.39
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.39 units on a scale	Standard Deviation 2.63
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.53 units on a scale	Standard Deviation 2.46
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.75 units on a scale	Standard Deviation 2.46
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.40 units on a scale	Standard Deviation 2.54
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.70 units on a scale	Standard Deviation 2.7
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-3.10 units on a scale	Standard Deviation 2.84
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.70 units on a scale	Standard Deviation 2.63
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.08 units on a scale	Standard Deviation 2.55
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.32 units on a scale	Standard Deviation 2.38
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.52 units on a scale	Standard Deviation 2.39
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.44 units on a scale	Standard Deviation 2.4
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.51 units on a scale	Standard Deviation 2.7
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.99 units on a scale	Standard Deviation 2.64
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.80 units on a scale	Standard Deviation 2.69
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.72 units on a scale	Standard Deviation 2.58
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.68 units on a scale	Standard Deviation 2.56
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.84 units on a scale	Standard Deviation 2.56
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-3.55 units on a scale	Standard Deviation 2.91

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.32695% CI: [-0.8, 0.27]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.27595% CI: [-0.24, 0.83]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.91895% CI: [-0.51, 0.56]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.47, -0.4]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.01395% CI: [-1.22, -0.15]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.57, -0.49]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00395% CI: [-1.36, -0.28]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00695% CI: [-1.29, -0.21]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.87, -0.79]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.68, -0.53]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00295% CI: [-1.48, -0.33]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.87, -0.72]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.02795% CI: [-1.28, -0.08]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.07195% CI: [-1.15, 0.05]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.78, -0.58]ANCOVA

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)

Participants answered, Question (Q)1: How much pain have you had when walking on a flat surface? and Q2: How much pain have you had when going up or down the stairs?. Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Population: mITT analysis set. BOCF method was used to impute missing values. Here, 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Q1	-2.38 units on a scale	Standard Deviation 2.65
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8: Q2	-2.34 units on a scale	Standard Deviation 2.5
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4: Q1	-2.55 units on a scale	Standard Deviation 2.5
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Q2	-2.13 units on a scale	Standard Deviation 2.68
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8: Q1	-2.41 units on a scale	Standard Deviation 2.64
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4: Q2	-2.54 units on a scale	Standard Deviation 2.53
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16: Q2	-2.28 units on a scale	Standard Deviation 2.55
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Q1	6.90 units on a scale	Standard Deviation 1.67
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2: Q1	-2.44 units on a scale	Standard Deviation 2.58
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Q1	-2.27 units on a scale	Standard Deviation 2.66
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16: Q1	-2.44 units on a scale	Standard Deviation 2.73
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Q2	-2.42 units on a scale	Standard Deviation 2.67
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2: Q2	-2.49 units on a scale	Standard Deviation 2.57
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Q2	8.10 units on a scale	Standard Deviation 1.45
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16: Q1	-3.26 units on a scale	Standard Deviation 3
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Q1	7.18 units on a scale	Standard Deviation 1.72
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Q2	8.21 units on a scale	Standard Deviation 1.55
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2: Q1	-3.23 units on a scale	Standard Deviation 2.87
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2: Q2	-3.08 units on a scale	Standard Deviation 2.84
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4: Q1	-3.78 units on a scale	Standard Deviation 2.9
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4: Q2	-3.67 units on a scale	Standard Deviation 2.96
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8: Q1	-3.40 units on a scale	Standard Deviation 2.95
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8: Q2	-3.28 units on a scale	Standard Deviation 2.91
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Q1	-3.73 units on a scale	Standard Deviation 2.98
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Q2	-3.77 units on a scale	Standard Deviation 3.08
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16: Q2	-3.23 units on a scale	Standard Deviation 3
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Q1	-3.10 units on a scale	Standard Deviation 3.08
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Q2	-3.10 units on a scale	Standard Deviation 3.09
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16: Q1	-3.42 units on a scale	Standard Deviation 2.84
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Q1	-3.03 units on a scale	Standard Deviation 2.8
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Q2	8.21 units on a scale	Standard Deviation 1.45
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2: Q2	-2.59 units on a scale	Standard Deviation 2.48
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16: Q2	-3.37 units on a scale	Standard Deviation 2.86
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Q1	7.28 units on a scale	Standard Deviation 1.59
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Q2	-3.48 units on a scale	Standard Deviation 3
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8: Q2	-3.26 units on a scale	Standard Deviation 2.52
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4: Q2	-3.43 units on a scale	Standard Deviation 2.6
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2: Q1	-2.58 units on a scale	Standard Deviation 2.56
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4: Q1	-3.49 units on a scale	Standard Deviation 2.49
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Q2	-2.97 units on a scale	Standard Deviation 2.89
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8: Q1	-3.30 units on a scale	Standard Deviation 2.45
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Q1	-3.51 units on a scale	Standard Deviation 2.82
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8: Q1	-3.86 units on a scale	Standard Deviation 2.73
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8: Q2	-3.95 units on a scale	Standard Deviation 2.87
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Q1	-3.56 units on a scale	Standard Deviation 3.13
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Q1	-3.75 units on a scale	Standard Deviation 2.8
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2: Q1	-2.95 units on a scale	Standard Deviation 2.73
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Q2	-3.95 units on a scale	Standard Deviation 3.04
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Q2	8.18 units on a scale	Standard Deviation 1.44
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16: Q1	-3.64 units on a scale	Standard Deviation 2.99
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Q2	-3.75 units on a scale	Standard Deviation 3.07
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16: Q2	-3.79 units on a scale	Standard Deviation 3.02
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4: Q1	-3.89 units on a scale	Standard Deviation 2.66
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline: Q1	6.96 units on a scale	Standard Deviation 1.71
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4: Q2	-3.94 units on a scale	Standard Deviation 2.8
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2: Q2	-2.99 units on a scale	Standard Deviation 2.66

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme 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, 16, 24

Population: mITT analysis set. LOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	6.64 units on a scale	Standard Deviation 1.59
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.33 units on a scale	Standard Deviation 2.47
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.39 units on a scale	Standard Deviation 2.52
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.17 units on a scale	Standard Deviation 2.4
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-2.35 units on a scale	Standard Deviation 2.55
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.27 units on a scale	Standard Deviation 2.46
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.06 units on a scale	Standard Deviation 2.36
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.04 units on a scale	Standard Deviation 2.6
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.01 units on a scale	Standard Deviation 2.55
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.36 units on a scale	Standard Deviation 2.59
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.55 units on a scale	Standard Deviation 2.53
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-2.96 units on a scale	Standard Deviation 2.63
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.85 units on a scale	Standard Deviation 2.62
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	6.86 units on a scale	Standard Deviation 1.58
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.12 units on a scale	Standard Deviation 2.31
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	6.91 units on a scale	Standard Deviation 1.49
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.34 units on a scale	Standard Deviation 2.27
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.16 units on a scale	Standard Deviation 2.32
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.49 units on a scale	Standard Deviation 2.52
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.31 units on a scale	Standard Deviation 2.53
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.11 units on a scale	Standard Deviation 2.62
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.51 units on a scale	Standard Deviation 2.54
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.78 units on a scale	Standard Deviation 2.62
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.81 units on a scale	Standard Deviation 2.47
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.61 units on a scale	Standard Deviation 2.57
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	6.69 units on a scale	Standard Deviation 1.62
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.80 units on a scale	Standard Deviation 2.49
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.64 units on a scale	Standard Deviation 2.51

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.04495% CI: [-1.07, -0.02]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.87595% CI: [-0.57, 0.48]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.12995% CI: [-0.93, 0.12]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.46, -0.41]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00495% CI: [-1.28, -0.24]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.71, -0.67]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00295% CI: [-1.33, -0.3]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.46, -0.43]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.04, -1.02]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.56, -0.51]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.52, -0.46]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.9, -0.85]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.0395% CI: [-1.12, -0.06]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00295% CI: [-1.39, -0.32]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.96, -0.9]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.08595% CI: [-1.03, 0.07]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.02695% CI: [-1.18, -0.08]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.94, -0.84]ANCOVA

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme 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, 24

Population: mITT analysis set. BOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.13 units on a scale	Standard Deviation 2.5
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.13 units on a scale	Standard Deviation 2.36
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.01 units on a scale	Standard Deviation 2.44
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.00 units on a scale	Standard Deviation 2.31
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.17 units on a scale	Standard Deviation 2.4
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.97 units on a scale	Standard Deviation 2.58
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.38 units on a scale	Standard Deviation 2.64
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.77 units on a scale	Standard Deviation 2.71
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.23 units on a scale	Standard Deviation 2.66
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.85 units on a scale	Standard Deviation 2.62
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.98 units on a scale	Standard Deviation 2.36
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.34 units on a scale	Standard Deviation 2.27
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.09 units on a scale	Standard Deviation 2.35
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.25 units on a scale	Standard Deviation 2.62
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.74 units on a scale	Standard Deviation 2.61
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.51 units on a scale	Standard Deviation 2.66
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.41 units on a scale	Standard Deviation 2.56
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.61 units on a scale	Standard Deviation 2.57
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.47 units on a scale	Standard Deviation 2.58
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-3.23 units on a scale	Standard Deviation 2.83

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.04495% CI: [-1.07, -0.02]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.87595% CI: [-0.57, 0.48]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.12995% CI: [-0.93, 0.12]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.51, -0.45]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00295% CI: [-1.38, -0.32]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.76, -0.7]ANCOVA

Comparison: Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00295% CI: [-1.35, -0.3]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00195% CI: [-1.39, -0.34]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.94, -0.9]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.7, -0.58]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.57, -0.45]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.91, -0.79]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.02195% CI: [-1.26, -0.1]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.02995% CI: [-1.22, -0.07]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.78, -0.62]ANCOVA

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)

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

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	6.94 units on a scale	Standard Deviation 1.8
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.40 units on a scale	Standard Deviation 2.45
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.42 units on a scale	Standard Deviation 2.57
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.09 units on a scale	Standard Deviation 2.53
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-2.45 units on a scale	Standard Deviation 2.55
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.31 units on a scale	Standard Deviation 2.52
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.11 units on a scale	Standard Deviation 2.47
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.07 units on a scale	Standard Deviation 2.86
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.96 units on a scale	Standard Deviation 2.8
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.44 units on a scale	Standard Deviation 2.71
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.59 units on a scale	Standard Deviation 2.82
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.07 units on a scale	Standard Deviation 2.77
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.91 units on a scale	Standard Deviation 2.79
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	6.98 units on a scale	Standard Deviation 1.9
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.22 units on a scale	Standard Deviation 2.47
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	7.05 units on a scale	Standard Deviation 1.69
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.50 units on a scale	Standard Deviation 2.6
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.32 units on a scale	Standard Deviation 2.61
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.62 units on a scale	Standard Deviation 2.72
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.36 units on a scale	Standard Deviation 2.67
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.07 units on a scale	Standard Deviation 2.71
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.66 units on a scale	Standard Deviation 2.79
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.94 units on a scale	Standard Deviation 2.88
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.99 units on a scale	Standard Deviation 2.75
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.70 units on a scale	Standard Deviation 2.82
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Baseline	6.89 units on a scale	Standard Deviation 2.04
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.04 units on a scale	Standard Deviation 2.79
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.83 units on a scale	Standard Deviation 2.72

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)

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

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.94 units on a scale	Standard Deviation 1.8
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.06 units on a scale	Standard Deviation 2.47
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.10 units on a scale	Standard Deviation 2.6
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.09 units on a scale	Standard Deviation 2.53
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.02 units on a scale	Standard Deviation 2.49
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.12 units on a scale	Standard Deviation 2.46
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.98 units on a scale	Standard Deviation 2.48
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.95 units on a scale	Standard Deviation 2.92
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.91 units on a scale	Standard Deviation 2.83
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.33 units on a scale	Standard Deviation 2.79
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.44 units on a scale	Standard Deviation 2.94
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.86 units on a scale	Standard Deviation 2.87
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.91 units on a scale	Standard Deviation 2.79
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.98 units on a scale	Standard Deviation 1.9
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.06 units on a scale	Standard Deviation 2.55
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.05 units on a scale	Standard Deviation 1.69
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.50 units on a scale	Standard Deviation 2.6
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.28 units on a scale	Standard Deviation 2.62
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.38 units on a scale	Standard Deviation 2.82
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.20 units on a scale	Standard Deviation 2.72
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.68 units on a scale	Standard Deviation 2.7
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.54 units on a scale	Standard Deviation 2.75
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-3.44 units on a scale	Standard Deviation 3.03
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.50 units on a scale	Standard Deviation 2.92
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.70 units on a scale	Standard Deviation 2.82
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.89 units on a scale	Standard Deviation 2.04
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.75 units on a scale	Standard Deviation 2.92
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.70 units on a scale	Standard Deviation 2.75

Secondary

Duration of Rescue Medication Use

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication.

Time frame: Week 2, 4, 8, 12, 16, 24

Population: mITT analysis set. LOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Group	Value (MEDIAN)
Placebo	Duration of Rescue Medication Use	Week 2	1.5 days
Placebo	Duration of Rescue Medication Use	Week 4	1.0 days
Placebo	Duration of Rescue Medication Use	Week 8	0.0 days
Placebo	Duration of Rescue Medication Use	Week 12	0.0 days
Placebo	Duration of Rescue Medication Use	Week 16	0.0 days
Placebo	Duration of Rescue Medication Use	Week 24	0.0 days
Tanezumab 2.5 mg	Duration of Rescue Medication Use	Week 24	0.0 days
Tanezumab 2.5 mg	Duration of Rescue Medication Use	Week 12	0.0 days
Tanezumab 2.5 mg	Duration of Rescue Medication Use	Week 2	1.0 days
Tanezumab 2.5 mg	Duration of Rescue Medication Use	Week 8	0.0 days
Tanezumab 2.5 mg	Duration of Rescue Medication Use	Week 4	0.0 days
Tanezumab 2.5 mg	Duration of Rescue Medication Use	Week 16	0.0 days
Tanezumab 5 mg	Duration of Rescue Medication Use	Week 4	0.0 days
Tanezumab 5 mg	Duration of Rescue Medication Use	Week 8	0.0 days
Tanezumab 5 mg	Duration of Rescue Medication Use	Week 12	0.0 days
Tanezumab 5 mg	Duration of Rescue Medication Use	Week 24	0.0 days
Tanezumab 5 mg	Duration of Rescue Medication Use	Week 16	0.0 days
Tanezumab 5 mg	Duration of Rescue Medication Use	Week 2	2.0 days
Tanezumab 10 mg	Duration of Rescue Medication Use	Week 16	0.0 days
Tanezumab 10 mg	Duration of Rescue Medication Use	Week 24	0.0 days
Tanezumab 10 mg	Duration of Rescue Medication Use	Week 4	0.0 days
Tanezumab 10 mg	Duration of Rescue Medication Use	Week 12	0.0 days
Tanezumab 10 mg	Duration of Rescue Medication Use	Week 2	1.0 days
Tanezumab 10 mg	Duration of Rescue Medication Use	Week 8	0.0 days

Secondary

Percentage of Participants Who Used Rescue Medications

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication.

Time frame: Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Who Used Rescue Medications	Week 2	68.2 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medications	Week 12	40.3 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medications	Week 16	38.3 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medications	Week 8	46.8 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medications	Week 4	55.2 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medications	Week 24	27.9 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medications	Week 4	40.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medications	Week 8	42.9 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medications	Week 24	35.7 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medications	Week 2	63.0 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medications	Week 12	30.5 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medications	Week 16	40.9 percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medications	Week 24	28.8 percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medications	Week 16	32.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medications	Week 2	65.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medications	Week 4	36.5 percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medications	Week 8	39.1 percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medications	Week 12	34.0 percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medications	Week 4	40.5 percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medications	Week 2	66.0 percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medications	Week 24	26.8 percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medications	Week 16	31.4 percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medications	Week 12	32.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medications	Week 8	39.9 percentage of participants

Secondary

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 2	11.7 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 4	10.4 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 8	9.1 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 12	15.6 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 16	13.6 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 24	16.2 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 24	20.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 12	32.5 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 2	24.0 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 8	23.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 4	31.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 16	24.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 4	24.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 8	19.9 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 12	24.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 24	18.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 16	23.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 2	14.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 16	30.5 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 24	32.5 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 4	37.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 12	39.6 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 2	21.4 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 8	33.8 percentage of participants

Secondary

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 16	15.6 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 4	11.7 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 24	18.8 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 8	10.4 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 12	17.5 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 2	11.7 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 8	23.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 2	24.0 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 16	25.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 12	33.1 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 24	21.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 4	32.5 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 24	21.8 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 4	24.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 12	25.0 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 8	21.2 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 2	14.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 16	25.0 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 8	35.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 2	21.4 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 4	38.3 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 24	39.6 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 12	42.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 16	35.7 percentage of participants

Secondary

Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)

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

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 16: >=50% reduction	39.0 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 24: >=50% reduction	40.3 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 12: >=50% reduction	39.0 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 2: >=30% reduction	57.8 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 16: >=30% reduction	51.3 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 4: >=30% reduction	57.1 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 4: >=50% reduction	40.3 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 2: >=50% reduction	40.9 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 24: >=30% reduction	48.7 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 8: >=30% reduction	50.0 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 8: >=50% reduction	38.3 percentage of participants
Placebo	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 12: >=30% reduction	52.6 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 2: >=50% reduction	44.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 12: >=30% reduction	67.5 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 4: >=50% reduction	56.5 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 16: >=30% reduction	64.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 16: >=50% reduction	50.6 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 12: >=50% reduction	57.1 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 2: >=30% reduction	60.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 8: >=50% reduction	48.7 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 8: >=30% reduction	65.6 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 4: >=30% reduction	66.2 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 24: >=50% reduction	47.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 24: >=30% reduction	59.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 12: >=50% reduction	56.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 2: >=30% reduction	50.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 2: >=50% reduction	32.1 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 4: >=30% reduction	66.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 4: >=50% reduction	50.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 8: >=30% reduction	67.9 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 8: >=50% reduction	50.0 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 12: >=30% reduction	66.0 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 16: >=30% reduction	65.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 16: >=50% reduction	50.0 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 24: >=30% reduction	59.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 24: >=50% reduction	44.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 8: >=50% reduction	63.6 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 8: >=30% reduction	74.0 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 2: >=30% reduction	55.2 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 16: >=50% reduction	61.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 4: >=50% reduction	57.8 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 4: >=30% reduction	72.1 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 24: >=50% reduction	57.1 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 24: >=30% reduction	66.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 12: >=50% reduction	57.8 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 12: >=30% reduction	73.4 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 2: >=50% reduction	41.6 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Week 16: >=30% reduction	68.2 percentage of participants

Secondary

Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

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

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16: >=50% reduction	42.2 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24: >=50% reduction	44.8 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12: >=50% reduction	42.9 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2: >=30% reduction	57.8 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16: >=30% reduction	61.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4: >=30% reduction	60.4 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4: >=50% reduction	42.2 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2: >=50% reduction	40.9 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24: >=30% reduction	61.0 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8: >=30% reduction	53.9 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8: >=50% reduction	39.0 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12: >=30% reduction	63.0 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2: >=50% reduction	44.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12: >=30% reduction	73.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4: >=50% reduction	57.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16: >=30% reduction	68.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16: >=50% reduction	53.2 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12: >=50% reduction	60.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2: >=30% reduction	60.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8: >=50% reduction	49.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8: >=30% reduction	66.9 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4: >=30% reduction	69.5 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24: >=50% reduction	51.9 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24: >=30% reduction	66.2 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12: >=50% reduction	58.3 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2: >=30% reduction	50.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2: >=50% reduction	32.1 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4: >=30% reduction	67.3 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4: >=50% reduction	50.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8: >=30% reduction	71.2 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8: >=50% reduction	51.3 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12: >=30% reduction	72.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16: >=30% reduction	70.5 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16: >=50% reduction	51.3 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24: >=30% reduction	68.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24: >=50% reduction	49.4 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8: >=50% reduction	65.6 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8: >=30% reduction	77.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2: >=30% reduction	55.2 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16: >=50% reduction	68.2 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4: >=50% reduction	59.1 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4: >=30% reduction	74.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24: >=50% reduction	64.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24: >=30% reduction	78.6 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12: >=50% reduction	61.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12: >=30% reduction	79.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2: >=50% reduction	41.6 percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16: >=30% reduction	78.6 percentage of participants

Secondary

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported.

Time frame: Baseline up to Week 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0%	61.0 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=30%	51.3 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=70%	23.4 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=10%	59.7 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=60%	31.8 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=40%	48.7 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=20%	54.5 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	=100%	0.1 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=90%	5.2 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=50%	67.5 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=80%	13.6 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=50%	50.6 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=80%	27.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=60%	39.0 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=70%	33.1 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=20%	70.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	=100%	4.5 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=30%	64.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=90%	14.9 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=40%	58.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=10%	75.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0%	79.2 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=90%	12.8 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0%	79.5 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=10%	78.2 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=20%	69.9 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=30%	65.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=40%	57.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=50%	50.0 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=60%	45.5 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=70%	39.1 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=80%	27.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	=100%	5.8 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=50%	61.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	=100%	7.1 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=80%	31.8 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=40%	67.5 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=30%	68.2 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=20%	70.1 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=90%	24.0 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=10%	74.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0%	76.0 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=70%	44.2 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=60%	55.8 percentage of participants

Secondary

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported.

Time frame: Baseline up to Week 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>0%	84.4 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=30%	61.7 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=70%	24.7 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=10%	77.9 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=60%	33.8 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=40%	55.2 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=20%	66.2 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	=100%	0.1 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=90%	5.8 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=50%	42.2 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=80%	14.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=50%	53.2 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=80%	27.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=60%	40.9 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=70%	33.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=20%	76.6 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	=100%	4.5 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=30%	68.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=90%	14.9 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=40%	62.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=10%	83.1 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>0%	87.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=90%	13.5 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>0%	92.9 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=10%	87.2 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=20%	75.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=30%	70.5 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=40%	60.3 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=50%	51.3 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=60%	46.2 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=70%	39.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=80%	28.2 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	=100%	5.8 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=50%	68.2 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	=100%	8.4 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=80%	34.4 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=40%	75.3 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=30%	78.6 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=20%	83.1 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=90%	25.3 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=10%	90.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>0%	92.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=70%	47.4 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=60%	62.3 percentage of participants

Secondary

Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)

OMERACT-OARSI response: greater than or equal to (\>=) 50 percent (%) improvement from baseline and absolute change from baseline of \>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).

Time frame: Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 2	62.3 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 4	57.1 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 8	52.6 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 12	53.2 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 16	53.9 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 24	51.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 24	62.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 12	74.7 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 2	68.2 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 8	72.1 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 4	70.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 16	68.2 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 4	75.0 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 8	73.7 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 12	74.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 24	64.1 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 16	69.9 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 2	60.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 16	70.8 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 24	69.5 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 4	77.3 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 12	77.9 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 2	68.2 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Week 8	78.6 percentage of participants

Secondary

Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)

OMERACT-OARSI response: \>= 50% improvement from baseline and absolute change from baseline of \>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).

Time frame: Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 16	65.6 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 4	61.7 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 24	65.6 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 8	57.1 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 12	64.9 percentage of participants
Placebo	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 2	62.3 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 8	73.4 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 2	68.2 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 16	72.7 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 12	80.5 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 24	70.8 percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 4	74.0 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 24	75.0 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 4	76.3 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 12	81.4 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 8	77.6 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 2	60.9 percentage of participants
Tanezumab 5 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 16	75.6 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 24	82.5 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 2	68.2 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 4	80.5 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 8	83.1 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 12	85.7 percentage of participants
Tanezumab 10 mg	Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Week 16	82.5 percentage of participants

Secondary

Time to Discontinuation Due to Lack of Efficacy

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

Time frame: Baseline up to Week 16

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

Arm	Measure	Value (MEDIAN)
Placebo	Time to Discontinuation Due to Lack of Efficacy	NA days
Tanezumab 2.5 mg	Time to Discontinuation Due to Lack of Efficacy	NA days
Tanezumab 5 mg	Time to Discontinuation Due to Lack of Efficacy	NA days
Tanezumab 10 mg	Time to Discontinuation Due to Lack of Efficacy	NA days

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026

Tanezumab in Osteoarthritis of the Knee

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

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

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

Amount of Rescue Medication Taken

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)

Duration of Rescue Medication Use

Percentage of Participants Who Used Rescue Medications

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)

Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

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

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

Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)

Time to Discontinuation Due to Lack of Efficacy