Tanezumab in Osteoarthritis Of The Hip

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00744471

Enrollment

627

Registered

2008-09-01

Start date

2008-11-17

Completion date

2010-08-13

Last updated

2021-02-26

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

Conditions

Arthritis, Osteoarthritis, Osteoarthritis, Hip

Keywords

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

Brief summary

The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients

Interventions

BIOLOGICALtanezumab

Tanezumab 10 mg IV every 8 weeks

BIOLOGICALPlacebo

Placebo to match tanezumab IV 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 hip according to ACR criteria with 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 Hip injections, arthroplasty or replacement 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 * 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 Score 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. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 16	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, 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 hip joint affects you, how are you doing today?, participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.

Secondary

Measure	Time frame	Description
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 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 osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, 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 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 24	Participants answered: Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?, participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	Participants answered: Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?, participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better 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	A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (\>=) 50 percent (%)and absolute change of \>=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], 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	A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (\>=) 50 percent (%)and absolute change of \>=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], higher score=higher pain/difficulty).
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	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 osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with \>=30% or \>=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities 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 osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Percentage of participants with \>=30% or \>=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: 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 by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.
Percentage of Participants With at Least 2 Points Improvement 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 by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 16	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, 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 at Week 16 were reported.
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	Baseline, Week 16	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, 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 at Week 16 were reported.
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16, 24	Participants assessed daily average hip joint pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Post baseline weekly scores were calculated as the mean of the scores over the last 7 days prior to each assessment time point.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 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 osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 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 osteoarthritis. 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 hip joint. Each item is scored on a 0 (no pain) to 10 (worst possible pain) NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no pain) to 10 (worst possible pain), where higher score indicates worse response.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 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 osteoarthritis. Participants answered How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 =extreme pain. Higher scores indicated more pain.
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 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 osteoarthritis. Participants answered 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 = worst possible pain, where higher scores indicating higher pain.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 12, 24	The SF-36 health survey was a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline, Week 12, 24	The SF-36 health survey was a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 8 domains were also summarized as summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for the each summary scores =0 to 100, where higher scores represented higher level of functioning. Higher summary scores indicated a better health related quality of life.
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 Medication	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 any use of rescue medication during the particular study week were summarized.
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. Number of days participant used any of the rescue medication, during the specified week were summarized.
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. The total dosage of acetaminophen in mg used during the specified week were summarized.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to Week 32	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and all non-serious adverse events.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Baseline, Week 2, 4, 6, 8, 12, 16, 24	The NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. Neurologic examination assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes in order to complete the NIS. The NIS is the sum of scores of over all 37 items (24 scored 0-4; 13 scored 0-2), made separately for left and right sides, giving a possible overall score range of 0 (no impairment) to 122 (severe impairment). NIS Total score range (total of both left and right sides) was 0 (no impairment) to 244 (severe impairment), where higher scores indicated increased impairment.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 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 osteoarthritis. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), giving an overall possible mean score range of 0 (minimum stiffness) to 10 (maximum stiffness). Higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of hip joint.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 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 osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 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 osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Countries

United States

Participant flow

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.	155
Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	155
Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	154
Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	157
Total	621

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	6	7	5	9
Overall Study	Death	0	0	0	1
Overall Study	Entered extension study	41	84	100	91
Overall Study	Lack of Efficacy	83	37	19	31
Overall Study	Lost to Follow-up	0	0	2	0
Overall Study	Other	2	3	6	2
Overall Study	Protocol Violation	1	4	1	2
Overall Study	Randomized but not treated	1	1	4	0
Overall Study	Withdrawal by Subject	9	9	15	12

Baseline characteristics

Characteristic	Placebo	Tanezumab 2.5 mg	Tanezumab 5 mg	Tanezumab 10 mg	Total
Age, Customized <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized >= 65 years	60 Participants	61 Participants	69 Participants	69 Participants	259 Participants
Age, Customized Between 18 and 44 years	11 Participants	8 Participants	11 Participants	6 Participants	36 Participants
Age, Customized Between 45 and 64 years	84 Participants	86 Participants	74 Participants	82 Participants	326 Participants
Sex: Female, Male Female	103 Participants	101 Participants	92 Participants	88 Participants	384 Participants
Sex: Female, Male Male	52 Participants	54 Participants	62 Participants	69 Participants	237 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 / 155	64 / 155	58 / 154	59 / 157
serious Total, serious adverse events	6 / 155	5 / 155	7 / 154	6 / 157

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 hip joint affects you, how are you doing today?, participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.

Time frame: Baseline, Week 16

Population: mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.

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	3.47 Units on a scale	Standard Deviation 0.6
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-0.34 Units on a scale	Standard Deviation 0.69
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	-0.67 Units on a scale	Standard Deviation 0.87
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.55 Units on a scale	Standard Deviation 0.62
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.51 Units on a scale	Standard Deviation 0.64
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	-0.80 Units on a scale	Standard Deviation 1
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.46 Units on a scale	Standard Deviation 0.66
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	-0.80 Units on a scale	Standard Deviation 0.94

Comparison: Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.p-value: 0.00195% CI: [-0.51, -0.13]ANCOVA

Comparison: Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.64, -0.25]ANCOVA

Comparison: Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.66, -0.28]ANCOVA

Primary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score 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. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Time frame: Baseline (Day 1), Week 16

Population: Modified intent-to-treat (mITT) analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. Overall Number of participants Analyzed = participants evaluable for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.26 Units on a scale	Standard Deviation 1.39
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.65 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 Score at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.86 Units on a scale	Standard Deviation 2.73
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.20 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 Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.24 Units on a scale	Standard Deviation 1.46
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.35 Units on a scale	Standard Deviation 2.76
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.33 Units on a scale	Standard Deviation 1.64
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.37 Units on a scale	Standard Deviation 2.8

Comparison: Change at Week 16: Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.87, -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: <0.00195% CI: [-2.28, -1.1]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: [-2.34, -1.16]ANCOVA

Primary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score 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. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, 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: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site.BOCF method used to impute missing values. Overall Number of participants Analyzed = participants 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 Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.79 Units on a scale	Standard Deviation 1.56
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.39 Units on a scale	Standard Deviation 2.25
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.54 Units on a scale	Standard Deviation 2.72
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.79 Units on a scale	Standard Deviation 1.63
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.82 Units on a scale	Standard Deviation 1.7
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.88 Units on a scale	Standard Deviation 2.7
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.83 Units on a scale	Standard Deviation 1.83
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.96 Units on a scale	Standard Deviation 2.68

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: [-1.74, -0.61]ANCOVA

Comparison: Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.06, -0.92]ANCOVA

Comparison: Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.17, -1.04]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. The total dosage of acetaminophen in mg used during the specified week were summarized.

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

Population: mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method was used to impute missing values. Here 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Amount of Rescue Medication Taken	Week 2	3917.76 milligram	Standard Deviation 4859.09
Placebo	Amount of Rescue Medication Taken	Week 4	3676.47 milligram	Standard Deviation 4774.68
Placebo	Amount of Rescue Medication Taken	Week 8	3163.40 milligram	Standard Deviation 4984.13
Placebo	Amount of Rescue Medication Taken	Week 12	2683.01 milligram	Standard Deviation 5597.74
Placebo	Amount of Rescue Medication Taken	Week 16	2366.01 milligram	Standard Deviation 4771.42
Placebo	Amount of Rescue Medication Taken	Week 24	2496.73 milligram	Standard Deviation 5120.42
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 24	2274.83 milligram	Standard Deviation 4808.22
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 12	2304.64 milligram	Standard Deviation 4477.34
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 2	3205.30 milligram	Standard Deviation 4485.63
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 8	2811.26 milligram	Standard Deviation 5086.17
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 4	2437.09 milligram	Standard Deviation 3932.47
Tanezumab 2.5 mg	Amount of Rescue Medication Taken	Week 16	2350.99 milligram	Standard Deviation 4710.91
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 4	2148.65 milligram	Standard Deviation 4331.68
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 8	2372.48 milligram	Standard Deviation 5138.01
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 12	2093.96 milligram	Standard Deviation 5141.37
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 24	2684.56 milligram	Standard Deviation 5787.73
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 16	2382.55 milligram	Standard Deviation 5197.9
Tanezumab 5 mg	Amount of Rescue Medication Taken	Week 2	3346.94 milligram	Standard Deviation 5405.67
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 16	1666.67 milligram	Standard Deviation 3542.07
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 24	1996.79 milligram	Standard Deviation 3717.65
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 4	1919.87 milligram	Standard Deviation 3183.88
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 12	1910.26 milligram	Standard Deviation 3648.9
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 2	3306.45 milligram	Standard Deviation 4470.46
Tanezumab 10 mg	Amount of Rescue Medication Taken	Week 8	2298.08 milligram	Standard Deviation 3592.46

Secondary

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

Time frame: Baseline, Week 12, 24

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 at a study site. BOCF method was used to impute missing values. Here, 'Number Analyzed', signified number of participants evaluable at specified time points.

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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:General health	1.69 Units on a scale	Standard Deviation 11.03
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Emotional	63.47 Units on a scale	Standard Deviation 30.57
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Health	3.77 Units on a scale	Standard Deviation 11.86
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Function	30.56 Units on a scale	Standard Deviation 19.51
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Vitality	3.77 Units on a scale	Standard Deviation 12.01
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Health	72.63 Units on a scale	Standard Deviation 18.7
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Vitality	5.24 Units on a scale	Standard Deviation 14.14
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Role Emotional	3.30 Units on a scale	Standard Deviation 17.19
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Physical Function	6.24 Units on a scale	Standard Deviation 16.12
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:General health	2.07 Units on a scale	Standard Deviation 9.34
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Vitality	47.28 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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: General health	64.81 Units on a scale	Standard Deviation 18.81
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Bodily Pain	9.16 Units on a scale	Standard Deviation 17.76
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week12:Physical Function	6.01 Units on a scale	Standard Deviation 15.12
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Role emotional	4.44 Units on a scale	Standard Deviation 21.01
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Social Function	5.52 Units on a scale	Standard Deviation 18.91
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Social Function	3.73 Units on a scale	Standard Deviation 18.25
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Physical	7.67 Units on a scale	Standard Deviation 20.91
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Social Function	64.37 Units on a scale	Standard Deviation 27.11
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Physical	39.25 Units on a scale	Standard Deviation 24.74
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Physical	7.55 Units on a scale	Standard Deviation 16.05
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Bodily Pain	10.42 Units on a scale	Standard Deviation 17.62
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Bodily Pain	29.70 Units on a scale	Standard Deviation 13.96
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Health	1.40 Units on a scale	Standard Deviation 11.34
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Health	74.30 Units on a scale	Standard Deviation 17.76
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Vitality	8.13 Units on a scale	Standard Deviation 15.66
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Social Function	10.25 Units on a scale	Standard Deviation 22.16
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Social Function	6.92 Units on a scale	Standard Deviation 19.62
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:General health	3.64 Units on a scale	Standard Deviation 10.99
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Role emotional	8.33 Units on a scale	Standard Deviation 19.14
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Health	4.07 Units on a scale	Standard Deviation 13.44
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Bodily Pain	29.66 Units on a scale	Standard Deviation 14.56
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: General health	67.04 Units on a scale	Standard Deviation 18.12
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Vitality	49.42 Units on a scale	Standard Deviation 20.93
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Health	3.53 Units on a scale	Standard Deviation 13.01
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Social Function	66.67 Units on a scale	Standard Deviation 25.32
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Vitality	6.46 Units on a scale	Standard Deviation 14.63
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Emotional	68.94 Units on a scale	Standard Deviation 28.34
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Physical Function	9.97 Units on a scale	Standard Deviation 16.87
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Function	29.66 Units on a scale	Standard Deviation 20.35
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Bodily Pain	11.39 Units on a scale	Standard Deviation 18.79
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:General health	4.01 Units on a scale	Standard Deviation 12.61
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week12:Physical Function	15.01 Units on a scale	Standard Deviation 21.38
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Role Emotional	7.72 Units on a scale	Standard Deviation 17.8
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Physical	12.04 Units on a scale	Standard Deviation 20.21
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Physical	16.88 Units on a scale	Standard Deviation 23.77
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Bodily Pain	17.97 Units on a scale	Standard Deviation 22.08
Tanezumab 2.5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Physical	36.96 Units on a scale	Standard Deviation 24.78
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Physical	38.83 Units on a scale	Standard Deviation 25.33
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: General health	63.74 Units on a scale	Standard Deviation 18.6
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Function	30.78 Units on a scale	Standard Deviation 19.69
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Bodily Pain	29.73 Units on a scale	Standard Deviation 15.78
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Vitality	48.04 Units on a scale	Standard Deviation 20.7
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Social Function	63.67 Units on a scale	Standard Deviation 28.76
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Emotional	67.22 Units on a scale	Standard Deviation 30.86
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Health	73.90 Units on a scale	Standard Deviation 18.8
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:General health	8.03 Units on a scale	Standard Deviation 14.24
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week12:Physical Function	18.52 Units on a scale	Standard Deviation 25.16
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Physical	22.83 Units on a scale	Standard Deviation 28.7
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Bodily Pain	25.23 Units on a scale	Standard Deviation 25.48
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Vitality	10.79 Units on a scale	Standard Deviation 19.82
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Social Function	12.08 Units on a scale	Standard Deviation 24.89
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Role emotional	11.72 Units on a scale	Standard Deviation 26.93
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Health	5.73 Units on a scale	Standard Deviation 15.87
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:General health	4.70 Units on a scale	Standard Deviation 12.88
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Physical Function	12.99 Units on a scale	Standard Deviation 22
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Physical	13.88 Units on a scale	Standard Deviation 26.31
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Bodily Pain	15.91 Units on a scale	Standard Deviation 21.97
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Vitality	6.83 Units on a scale	Standard Deviation 17.58
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Social Function	8.83 Units on a scale	Standard Deviation 22.74
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Role Emotional	7.56 Units on a scale	Standard Deviation 23.81
Tanezumab 5 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Health	1.73 Units on a scale	Standard Deviation 13.94
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Physical Function	14.25 Units on a scale	Standard Deviation 21.6
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Role Physical	18.99 Units on a scale	Standard Deviation 27.1
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week12:Physical Function	18.91 Units on a scale	Standard Deviation 24.96
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Mental Health	1.60 Units on a scale	Standard Deviation 15.06
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Role Physical	13.63 Units on a scale	Standard Deviation 22.54
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:General health	5.27 Units on a scale	Standard Deviation 13.14
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Mental Health	73.32 Units on a scale	Standard Deviation 19.63
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Role Emotional	5.97 Units on a scale	Standard Deviation 22.19
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Bodily Pain	14.94 Units on a scale	Standard Deviation 21.55
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Emotional	68.76 Units on a scale	Standard Deviation 30.26
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Social Function	66.61 Units on a scale	Standard Deviation 28.39
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: General health	64.26 Units on a scale	Standard Deviation 19.29
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: Vitality	6.61 Units on a scale	Standard Deviation 15.31
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Vitality	46.85 Units on a scale	Standard Deviation 22.81
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Role Physical	38.47 Units on a scale	Standard Deviation 23.86
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Bodily Pain	31.25 Units on a scale	Standard Deviation 16.27
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Mental Health	2.55 Units on a scale	Standard Deviation 16.15
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Role emotional	9.68 Units on a scale	Standard Deviation 23.43
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Social Function	10.08 Units on a scale	Standard Deviation 24.88
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:Social Function	5.73 Units on a scale	Standard Deviation 19.6
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24:General health	4.17 Units on a scale	Standard Deviation 13.82
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Vitality	7.86 Units on a scale	Standard Deviation 20.03
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: Bodily Pain	22.87 Units on a scale	Standard Deviation 26.1
Tanezumab 10 mg	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: Physical Function	29.48 Units on a scale	Standard Deviation 19.29

Secondary

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

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

Time frame: Baseline, Week 12, 24

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 at a study site. BOCF method was used to impute missing values. Here, 'Overall Number of Participants Analyzed', signified number of participants evaluable for this outcome measure for respective reporting groups.

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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: MCA	-0.03 Units on a scale	Standard Deviation 1.2
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: PCA	-1.90 Units on a scale	Standard Deviation 0.72
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: MCA	0.15 Units on a scale	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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: PCA	0.29 Units on a scale	Standard Deviation 0.64
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: MCA	0.04 Units on a scale	Standard Deviation 0.69
Placebo	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: PCA	0.31 Units on a scale	Standard Deviation 0.63
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: PCA	0.42 Units on a scale	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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: PCA	0.66 Units on a scale	Standard Deviation 0.9
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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: MCA	0.18 Units on a scale	Standard Deviation 1.15
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: MCA	0.19 Units on a scale	Standard Deviation 0.81
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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: PCA	-1.99 Units on a scale	Standard Deviation 0.82
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: MCA	0.20 Units on a scale	Standard Deviation 0.7
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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: PCA	-1.96 Units on a scale	Standard Deviation 0.77
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: MCA	0.26 Units on a scale	Standard Deviation 1.02
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: PCA	0.89 Units on a scale	Standard Deviation 1.05
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: PCA	0.60 Units on a scale	Standard Deviation 0.91
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: MCA	0.12 Units on a scale	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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: MCA	0.06 Units on a scale	Standard Deviation 1.26
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: MCA	0.04 Units on a scale	Standard Deviation 0.87
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24: PCA	0.61 Units on a scale	Standard Deviation 0.86
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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: PCA	-1.97 Units on a scale	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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: PCA	0.84 Units on a scale	Standard Deviation 1.02
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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline: MCA	0.11 Units on a scale	Standard Deviation 1.29
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12: MCA	0.10 Units on a scale	Standard Deviation 0.96

Secondary

Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Participants assessed daily average hip joint pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Post baseline weekly scores were calculated as the mean of the scores over the last 7 days prior to each assessment time point.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.34 Units on a scale	Standard Deviation 2.15
Placebo	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.99 Units on a scale	Standard Deviation 2
Placebo	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.16 Units on a scale	Standard Deviation 2.07
Placebo	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-0.97 Units on a scale	Standard Deviation 1.9
Placebo	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.18 Units on a scale	Standard Deviation 2.06
Placebo	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.24 Units on a scale	Standard Deviation 1.97
Placebo	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.61 Units on a scale	Standard Deviation 1.86
Tanezumab 2.5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.02 Units on a scale	Standard Deviation 2.4
Tanezumab 2.5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.44 Units on a scale	Standard Deviation 1.89
Tanezumab 2.5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.89 Units on a scale	Standard Deviation 2.4
Tanezumab 2.5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.44 Units on a scale	Standard Deviation 2.42
Tanezumab 2.5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.00 Units on a scale	Standard Deviation 2.37
Tanezumab 2.5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.19 Units on a scale	Standard Deviation 2.58
Tanezumab 2.5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-1.55 Units on a scale	Standard Deviation 2.29
Tanezumab 5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.51 Units on a scale	Standard Deviation 2.51
Tanezumab 5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.39 Units on a scale	Standard Deviation 2.55
Tanezumab 5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.24 Units on a scale	Standard Deviation 2.61
Tanezumab 5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.71 Units on a scale	Standard Deviation 1.93
Tanezumab 5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.10 Units on a scale	Standard Deviation 2.55
Tanezumab 5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.84 Units on a scale	Standard Deviation 2.62
Tanezumab 5 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.50 Units on a scale	Standard Deviation 2.48
Tanezumab 10 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.03 Units on a scale	Standard Deviation 2.57
Tanezumab 10 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.44 Units on a scale	Standard Deviation 2.59
Tanezumab 10 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.83 Units on a scale	Standard Deviation 2.82
Tanezumab 10 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	6.55 Units on a scale	Standard Deviation 1.96
Tanezumab 10 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.56 Units on a scale	Standard Deviation 2.64
Tanezumab 10 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.65 Units on a scale	Standard Deviation 2.65
Tanezumab 10 mg	Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.12 Units on a scale	Standard Deviation 2.59

Secondary

Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24

The NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. Neurologic examination assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes in order to complete the NIS. The NIS is the sum of scores of over all 37 items (24 scored 0-4; 13 scored 0-2), made separately for left and right sides, giving a possible overall score range of 0 (no impairment) to 122 (severe impairment). NIS Total score range (total of both left and right sides) was 0 (no impairment) to 244 (severe impairment), where higher scores indicated increased impairment.

Time frame: Baseline, Week 2, 4, 6, 8, 12, 16, 24

Population: Safety population included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 2	-0.09 Units on a scale	Standard Deviation 1.44
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 4	-0.03 Units on a scale	Standard Deviation 2.29
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 8	-0.23 Units on a scale	Standard Deviation 2.04
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 12	-0.23 Units on a scale	Standard Deviation 1.16
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 16	0.07 Units on a scale	Standard Deviation 1.48
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 24	-0.06 Units on a scale	Standard Deviation 0.83
Tanezumab 2.5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 24	-0.17 Units on a scale	Standard Deviation 1.72
Tanezumab 2.5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 12	-0.40 Units on a scale	Standard Deviation 1.96
Tanezumab 2.5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 2	-0.22 Units on a scale	Standard Deviation 1.92
Tanezumab 2.5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 8	-0.45 Units on a scale	Standard Deviation 1.74
Tanezumab 2.5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 4	0.03 Units on a scale	Standard Deviation 2.32
Tanezumab 2.5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 16	-0.33 Units on a scale	Standard Deviation 2.51
Tanezumab 5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 4	-0.38 Units on a scale	Standard Deviation 1.16
Tanezumab 5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 8	-0.38 Units on a scale	Standard Deviation 1.6
Tanezumab 5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 12	-0.41 Units on a scale	Standard Deviation 1.71
Tanezumab 5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 24	-0.46 Units on a scale	Standard Deviation 1.63
Tanezumab 5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 16	-0.36 Units on a scale	Standard Deviation 1.63
Tanezumab 5 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 2	-0.21 Units on a scale	Standard Deviation 1.03
Tanezumab 10 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 16	-0.40 Units on a scale	Standard Deviation 2.07
Tanezumab 10 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 24	-0.20 Units on a scale	Standard Deviation 1.59
Tanezumab 10 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 4	-0.45 Units on a scale	Standard Deviation 1.52
Tanezumab 10 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 12	-0.47 Units on a scale	Standard Deviation 1.45
Tanezumab 10 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 2	-0.10 Units on a scale	Standard Deviation 1.4
Tanezumab 10 mg	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24	Change at Week 8	-0.35 Units on a scale	Standard Deviation 1.71

Secondary

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

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

Population: mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.38 Units on a scale	Standard Deviation 0.86
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-0.45 Units on a scale	Standard Deviation 0.81
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-0.42 Units on a scale	Standard Deviation 0.9
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.46 Units on a scale	Standard Deviation 0.9
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-0.44 Units on a scale	Standard Deviation 0.9
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.41 Units on a scale	Standard Deviation 0.83
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.73 Units on a scale	Standard Deviation 0.95
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.76 Units on a scale	Standard Deviation 0.95
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-0.87 Units on a scale	Standard Deviation 0.99
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-0.71 Units on a scale	Standard Deviation 0.95
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.83 Units on a scale	Standard Deviation 0.94
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-0.95 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 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.89 Units on a scale	Standard Deviation 1.05
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.17 Units on a scale	Standard Deviation 0.97
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-1.14 Units on a scale	Standard Deviation 1.05
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.96 Units on a scale	Standard Deviation 1.04
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.08 Units on a scale	Standard Deviation 1.02
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-0.90 Units on a scale	Standard Deviation 1.08
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-0.74 Units on a scale	Standard Deviation 0.98
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.81 Units on a scale	Standard Deviation 0.92
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.03 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 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.90 Units on a scale	Standard Deviation 0.96
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-1.01 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 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.88 Units on a scale	Standard Deviation 0.99

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, 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 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.83, -0.45]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.6, -0.22]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.65, -0.27]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.87, -0.5]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, 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 effect, baseline value, as a covariate, and study site as a random effect.p-value: 0.02295% CI: [-0.43, -0.03]ANCOVA

Comparison: Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.67, -0.27]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.65, -0.26]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.6, -0.19]ANCOVA

Comparison: Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.88, -0.47]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.79, -0.39]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.53, -0.14]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.68, -0.28]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.71, -0.32]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: 0.0195% CI: [-0.47, -0.06]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.66, -0.25]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: 0.00195% CI: [-0.53, -0.13]ANCOVA

Secondary

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-0.41 Units on a scale	Standard Deviation 0.76
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-0.44 Units on a scale	Standard Deviation 0.79
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-0.36 Units on a scale	Standard Deviation 0.72
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.43 Units on a scale	Standard Deviation 0.86
Placebo	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.41 Units on a scale	Standard Deviation 0.83
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.65 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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-0.78 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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-0.61 Units on a scale	Standard Deviation 0.84
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-0.93 Units on a scale	Standard Deviation 0.88
Tanezumab 2.5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.83 Units on a scale	Standard Deviation 0.94
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.93 Units on a scale	Standard Deviation 1.03
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.08 Units on a scale	Standard Deviation 1.02
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.16 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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.03 Units on a scale	Standard Deviation 1.05
Tanezumab 5 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-0.78 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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-0.92 Units on a scale	Standard Deviation 0.96
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-0.97 Units on a scale	Standard Deviation 0.98
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.81 Units on a scale	Standard Deviation 0.92
Tanezumab 10 mg	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.86 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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-0.60 Units on a scale	Standard Deviation 0.89

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, 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 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.83, -0.45]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.6, -0.22]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.65, -0.27]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.88, -0.5]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.73, -0.36]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: 0.05495% CI: [-0.39, 0]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.68, -0.29]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.65, -0.26]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.55, -0.15]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.81, -0.4]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.73, -0.32]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: 0.00895% CI: [-0.45, -0.07]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.6, -0.22]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: 0.01295% CI: [-0.43, -0.05]ANCOVA

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 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 osteoarthritis. 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 hip joint. Each item is scored on a 0 (no pain) to 10 (worst possible pain) NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no pain) to 10 (worst possible pain), 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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.08 Units on a scale	Standard Deviation 1.39
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.48 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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.62 Units on a scale	Standard Deviation 2.23
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.73 Units on a scale	Standard Deviation 1.97
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-1.35 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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.62 Units on a scale	Standard Deviation 2.02
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.47 Units on a scale	Standard Deviation 2.22
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.65 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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.63 Units on a scale	Standard Deviation 2.56
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.27 Units on a scale	Standard Deviation 2.54
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.05 Units on a scale	Standard Deviation 2.82
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.34 Units on a scale	Standard Deviation 2.66
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 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.13 Units on a scale	Standard Deviation 2.5
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 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.05 Units on a scale	Standard Deviation 1.42
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.17 Units on a scale	Standard Deviation 2.57
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.03 Units on a scale	Standard Deviation 1.57
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.50 Units on a scale	Standard Deviation 2.57
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.80 Units on a scale	Standard Deviation 2.53
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.51 Units on a scale	Standard Deviation 2.78
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.10 Units on a scale	Standard Deviation 2.72
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.85 Units on a scale	Standard Deviation 2.72
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.70 Units on a scale	Standard Deviation 2.65
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-3.00 Units on a scale	Standard Deviation 2.72
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.22 Units on a scale	Standard Deviation 2.73
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.17 Units on a scale	Standard Deviation 2.55
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.13 Units on a scale	Standard Deviation 1.63
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.65 Units on a scale	Standard Deviation 2.93
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.45 Units on a scale	Standard Deviation 2.66

Secondary

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

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

Population: mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. Overall Number of Participants Analyzed= participants evaluable for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.94 Units on a scale	Standard Deviation 2.08
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.02 Units on a scale	Standard Deviation 2.18
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-1.86 Units on a scale	Standard Deviation 2.32
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.12 Units on a scale	Standard Deviation 2.48
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.05 Units on a scale	Standard Deviation 2.47
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-1.97 Units on a scale	Standard Deviation 2.5
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.16 Units on a scale	Standard Deviation 2.62
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.58 Units on a scale	Standard Deviation 2.71
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-3.32 Units on a scale	Standard Deviation 2.59
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.95 Units on a scale	Standard Deviation 2.5
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.55 Units on a scale	Standard Deviation 2.59
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.23 Units on a scale	Standard Deviation 2.59
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-4.04 Units on a scale	Standard Deviation 2.6
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.52 Units on a scale	Standard Deviation 2.61
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.03 Units on a scale	Standard Deviation 2.67
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.56 Units on a scale	Standard Deviation 2.74
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.66 Units on a scale	Standard Deviation 2.74
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-3.71 Units on a scale	Standard Deviation 2.53
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.96 Units on a scale	Standard Deviation 2.61
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.77 Units on a scale	Standard Deviation 2.6
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-4.04 Units on a scale	Standard Deviation 2.59
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.35 Units on a scale	Standard Deviation 2.69
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-3.30 Units on a scale	Standard Deviation 2.52
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.89 Units on a scale	Standard Deviation 2.69

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: [-1.93, -0.88]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: [-2.26, -1.2]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: [-1.85, -0.8]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: [-2.08, -1.02]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: [-2.52, -1.46]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: [-2.54, -1.48]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: [-1.71, -0.63]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: [-2.21, -1.12]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: [-2.6, -1.52]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: [-2.11, -0.99]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: [-2.45, -1.32]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: [-2.82, -1.7]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: [-1.82, -0.71]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: [-2.15, -1.03]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: [-2.51, -1.4]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: [-1.85, -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: <0.00195% CI: [-2.15, -1.01]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: [-2.4, -1.27]ANCOVA

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.81 Units on a scale	Standard Deviation 2.44
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.92 Units on a scale	Standard Deviation 2.17
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-1.45 Units on a scale	Standard Deviation 2.43
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.74 Units on a scale	Standard Deviation 2.33
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.94 Units on a scale	Standard Deviation 2.08
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.76 Units on a scale	Standard Deviation 2.62
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.24 Units on a scale	Standard Deviation 2.89
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.54 Units on a scale	Standard Deviation 2.74
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.46 Units on a scale	Standard Deviation 2.64
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.32 Units on a scale	Standard Deviation 2.59
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.36 Units on a scale	Standard Deviation 2.6
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.71 Units on a scale	Standard Deviation 2.53
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.99 Units on a scale	Standard Deviation 2.63
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.67 Units on a scale	Standard Deviation 2.79
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-3.00 Units on a scale	Standard Deviation 2.8
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.77 Units on a scale	Standard Deviation 2.98
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.88 Units on a scale	Standard Deviation 2.74
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.30 Units on a scale	Standard Deviation 2.52
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.70 Units on a scale	Standard Deviation 2.71
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-3.06 Units on a scale	Standard Deviation 2.8

Comparison: Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.93, -0.88]ANCOVA

Comparison: Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.26, -1.2]ANCOVA

Comparison: Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.85, -0.8]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: [-2.11, -1.02]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: [-2.57, -1.48]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: [-2.5, -1.41]ANCOVA

Comparison: Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.65, -0.53]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: [-2.2, -1.08]ANCOVA

Comparison: Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.56, -1.45]ANCOVA

Comparison: Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.1, -0.88]ANCOVA

Comparison: Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.46, -1.25]ANCOVA

Comparison: Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.57, -1.37]ANCOVA

Comparison: Change at Week 24: ANCOVA model 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, -0.56]ANCOVA

Comparison: Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.12, -0.92]ANCOVA

Comparison: Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.2, -1.01]ANCOVA

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 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 osteoarthritis. Participants answered How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 =extreme pain. Higher scores indicated more 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 Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Baseline	7.26 Units on a scale	Standard Deviation 1.66
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.56 Units on a scale	Standard Deviation 2.43
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.76 Units on a scale	Standard Deviation 2.51
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.83 Units on a scale	Standard Deviation 2.39
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 24	-1.44 Units on a scale	Standard Deviation 2.43
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.96 Units on a scale	Standard Deviation 2.38
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.71 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 Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.73 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 (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.84 Units on a scale	Standard Deviation 2.73
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.40 Units on a scale	Standard Deviation 2.73
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.13 Units on a scale	Standard Deviation 2.97
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.45 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 Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.31 Units on a scale	Standard Deviation 2.81
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Baseline	7.21 Units on a scale	Standard Deviation 1.65
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.25 Units on a scale	Standard Deviation 2.77
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Baseline	7.25 Units on a scale	Standard Deviation 1.61
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.79 Units on a scale	Standard Deviation 2.71
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 4	-4.01 Units on a scale	Standard Deviation 2.83
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.65 Units on a scale	Standard Deviation 2.9
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.29 Units on a scale	Standard Deviation 2.98
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.95 Units on a scale	Standard Deviation 2.93
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.75 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 (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.94 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 (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.21 Units on a scale	Standard Deviation 2.81
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.33 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 Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Baseline	7.32 Units on a scale	Standard Deviation 1.76
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.59 Units on a scale	Standard Deviation 2.96
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.45 Units on a scale	Standard Deviation 2.71

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 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 osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, 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: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. Overall Number of Participants Analyzed = participants 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 Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.56 Units on a scale	Standard Deviation 2.01
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.51 Units on a scale	Standard Deviation 2.05
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-1.40 Units on a scale	Standard Deviation 2.24
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-1.61 Units on a scale	Standard Deviation 2.39
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-1.56 Units on a scale	Standard Deviation 2.41
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-1.46 Units on a scale	Standard Deviation 2.42
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-2.71 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 Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.12 Units on a scale	Standard Deviation 2.82
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.88 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 Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.66 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 Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.13 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 Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.83 Units on a scale	Standard Deviation 2.72
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.67 Units on a scale	Standard Deviation 2.43
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.14 Units on a scale	Standard Deviation 2.44
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.58 Units on a scale	Standard Deviation 2.63
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.09 Units on a scale	Standard Deviation 2.61
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.16 Units on a scale	Standard Deviation 2.72
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-3.32 Units on a scale	Standard Deviation 2.5
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.42 Units on a scale	Standard Deviation 2.6
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-3.34 Units on a scale	Standard Deviation 2.56
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.52 Units on a scale	Standard Deviation 2.48
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.85 Units on a scale	Standard Deviation 2.68
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.90 Units on a scale	Standard Deviation 2.46
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.35 Units on a scale	Standard Deviation 2.64

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.83, -0.8]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.23, -1.19]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.83, -0.8]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.1, -1.08]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.61, -1.59]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.51, -1.49]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.83, -0.76]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.26, -1.19]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.53, -1.46]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.11, -1]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.49, -1.37]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.83, -1.72]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.87, -0.75]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.14, -1.02]ANCOVA

Comparison: Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.47, -1.36]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.86, -0.74]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.17, -1.05]ANCOVA

Comparison: Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.47, -1.36]ANCOVA

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.52 Units on a scale	Standard Deviation 2.19
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.44 Units on a scale	Standard Deviation 1.99
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-1.27 Units on a scale	Standard Deviation 2.18
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.33 Units on a scale	Standard Deviation 2.21
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.56 Units on a scale	Standard Deviation 2.01
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.48 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 Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.86 Units on a scale	Standard Deviation 2.86
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.19 Units on a scale	Standard Deviation 2.65
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.06 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 Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.88 Units on a scale	Standard Deviation 2.53
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.95 Units on a scale	Standard Deviation 2.45
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.32 Units on a scale	Standard Deviation 2.5
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.62 Units on a scale	Standard Deviation 2.43
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.27 Units on a scale	Standard Deviation 2.71
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.62 Units on a scale	Standard Deviation 2.61
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.39 Units on a scale	Standard Deviation 2.85
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-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) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.90 Units on a scale	Standard Deviation 2.46
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.17 Units on a scale	Standard Deviation 2.61
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.78 Units on a scale	Standard Deviation 2.67

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.83, -0.8]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.23, -1.19]ANCOVA

Comparison: Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.83, -0.8]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.12, -1.08]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.64, -1.6]ANCOVA

Comparison: Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.46, -1.43]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.72, -0.64]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.18, -1.09]ANCOVA

Comparison: Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.43, -1.35]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.93, -0.77]ANCOVA

Comparison: Change at Week 12 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.31, -1.15]ANCOVA

Comparison: Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-2.47, -1.32]ANCOVA

Comparison: Change at Week 24 : ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.52, -0.4]ANCOVA

Comparison: Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.91, -0.78]ANCOVA

Secondary

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

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 Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.18 Units on a scale	Standard Deviation 1.65
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.39 Units on a scale	Standard Deviation 2.32
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.52 Units on a scale	Standard Deviation 2.3
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.69 Units on a scale	Standard Deviation 2.25
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-1.32 Units on a scale	Standard Deviation 2.35
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.51 Units on a scale	Standard Deviation 2.25
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.34 Units on a scale	Standard Deviation 2.41
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.54 Units on a scale	Standard Deviation 2.76
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.61 Units on a scale	Standard Deviation 2.69
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.29 Units on a scale	Standard Deviation 2.72
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.05 Units on a scale	Standard Deviation 2.95
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.30 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 Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.13 Units on a scale	Standard Deviation 2.67
Tanezumab 2.5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.17 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 Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.17 Units on a scale	Standard Deviation 3.08
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.02 Units on a scale	Standard Deviation 2.01
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.47 Units on a scale	Standard Deviation 3.02
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.80 Units on a scale	Standard Deviation 2.89
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.60 Units on a scale	Standard Deviation 3.13
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.09 Units on a scale	Standard Deviation 3
Tanezumab 5 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.93 Units on a scale	Standard Deviation 3.08
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.82 Units on a scale	Standard Deviation 3
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-3.16 Units on a scale	Standard Deviation 3.04
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.33 Units on a scale	Standard Deviation 2.99
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.32 Units on a scale	Standard Deviation 3.04
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.23 Units on a scale	Standard Deviation 1.96
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.78 Units on a scale	Standard Deviation 3.19
Tanezumab 10 mg	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.46 Units on a scale	Standard Deviation 2.97

Secondary

Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 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 osteoarthritis. Participants answered 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 = worst possible pain, where higher scores indicating higher pain.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.99 Units on a scale	Standard Deviation 1.46
Placebo	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.56 Units on a scale	Standard Deviation 2.5
Placebo	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.75 Units on a scale	Standard Deviation 2.49
Placebo	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.88 Units on a scale	Standard Deviation 2.15
Placebo	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-1.45 Units on a scale	Standard Deviation 2.46
Placebo	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.84 Units on a scale	Standard Deviation 2.26
Placebo	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.64 Units on a scale	Standard Deviation 2.32
Tanezumab 2.5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.95 Units on a scale	Standard Deviation 3
Tanezumab 2.5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.87 Units on a scale	Standard Deviation 2.84
Tanezumab 2.5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.59 Units on a scale	Standard Deviation 2.82
Tanezumab 2.5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.39 Units on a scale	Standard Deviation 3.1
Tanezumab 2.5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.54 Units on a scale	Standard Deviation 2.92
Tanezumab 2.5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.42 Units on a scale	Standard Deviation 2.62
Tanezumab 2.5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.94 Units on a scale	Standard Deviation 1.51
Tanezumab 5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.46 Units on a scale	Standard Deviation 2.92
Tanezumab 5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.83 Units on a scale	Standard Deviation 1.59
Tanezumab 5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.89 Units on a scale	Standard Deviation 2.85
Tanezumab 5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-4.11 Units on a scale	Standard Deviation 2.87
Tanezumab 5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.80 Units on a scale	Standard Deviation 3.08
Tanezumab 5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.41 Units on a scale	Standard Deviation 3.11
Tanezumab 5 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.98 Units on a scale	Standard Deviation 3.04
Tanezumab 10 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.82 Units on a scale	Standard Deviation 3.03
Tanezumab 10 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 24	-2.92 Units on a scale	Standard Deviation 3.03
Tanezumab 10 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.21 Units on a scale	Standard Deviation 3.03
Tanezumab 10 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.35 Units on a scale	Standard Deviation 2.71
Tanezumab 10 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Baseline	7.89 Units on a scale	Standard Deviation 1.81
Tanezumab 10 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.72 Units on a scale	Standard Deviation 3.23
Tanezumab 10 mg	Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.59 Units on a scale	Standard Deviation 3.05

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. Number of days participant used any of the rescue medication, during the specified week were summarized.

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

Population: mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method was used to impute missing values. Here, 'Number Analyzed', signified number of participants evaluable at specified time points.

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

Secondary

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and all non-serious adverse events.

Time frame: Baseline up to Week 32

Population: Safety population included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	68 Participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	6 Participants
Tanezumab 2.5 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	5 Participants
Tanezumab 2.5 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	90 Participants
Tanezumab 5 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	84 Participants
Tanezumab 5 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	7 Participants
Tanezumab 10 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	89 Participants
Tanezumab 10 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	6 Participants

Secondary

Percentage of Participants Who Used Rescue Medication

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

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

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 at a study site. LOCF method was used to impute missing values. Here, 'Number Analyzed', signified number of participants evaluable at specified time points.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Who Used Rescue Medication	Week 12	25.5 Percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	Week 4	45.8 Percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	Week 8	30.7 Percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	Week 2	46.1 Percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	Week 16	23.5 Percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	Week 24	23.5 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medication	Week 16	24.5 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medication	Week 24	25.8 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medication	Week 4	26.5 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medication	Week 8	26.5 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medication	Week 2	37.1 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants Who Used Rescue Medication	Week 12	22.5 Percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medication	Week 4	23.6 Percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medication	Week 16	24.2 Percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medication	Week 12	15.4 Percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medication	Week 2	36.1 Percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medication	Week 8	22.1 Percentage of participants
Tanezumab 5 mg	Percentage of Participants Who Used Rescue Medication	Week 24	22.8 Percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medication	Week 24	24.4 Percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medication	Week 4	23.1 Percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medication	Week 8	29.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medication	Week 12	20.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medication	Week 16	16.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants Who Used Rescue Medication	Week 2	37.4 Percentage of participants

Secondary

Percentage of Participants With at Least 2 Points Improvement 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 by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.

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 at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 16	8.4 Percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	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 at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 24	9.7 Percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 8	11.0 Percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 12	12.3 Percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 2	9.7 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 at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 8	18.0 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 at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 16	18.7 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 at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 12	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 at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 24	19.3 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 at Week 2, 4, 8, 12, 16, 24: 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 at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 4	26.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 16	23.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 4	34.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 12	31.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 8	28.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 2	32.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 24	25.3 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 24	23.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 2	24.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 4	34.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 8	28.4 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 12	32.9 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)	Week 16	30.3 Percentage of participants

Secondary

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)

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

Population: mITT analysis set: 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 at a study site. BOCF method was used to impute missing values.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 16	7.1 Percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 2	9.7 Percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 24	8.4 Percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	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 at Week 2, 4, 8, 12 ,16 and 24: 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 at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 12	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 at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 16	14.7 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 at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 12	22.0 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 at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 24	15.3 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 at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 4	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 at Week 2, 4, 8, 12 ,16 and 24: 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 at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 8	15.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 8	27.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 2	32.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 4	34.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 12	28.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 16	20.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 24	20.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 24	18.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 16	27.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 4	31.6 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 2	24.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 12	29.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)	Week 8	27.1 Percentage of participants

Secondary

Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward

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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 16: >= 50% reduction	26.0 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 24: >= 50% reduction	19.5 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 12: >= 50% reduction	26.0 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 2: >=30% reduction	38.3 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 16: >= 30% reduction	32.5 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 4: >=30% reduction	37.7 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 4: >=50% reduction	23.4 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 2: >=50% reduction	26.0 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 24: >= 30% reduction	27.9 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 8: >=30% reduction	36.4 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 8: >= 50% reduction	22.1 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 12: >= 30% reduction	37.7 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 2: >=50% reduction	49.0 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 12: >= 30% reduction	59.6 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 4: >=50% reduction	50.3 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 16: >= 30% reduction	56.3 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 16: >= 50% reduction	39.7 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 12: >= 50% reduction	49.0 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 2: >=30% reduction	64.2 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 8: >= 50% reduction	40.4 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 8: >=30% reduction	59.6 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 4: >=30% reduction	65.6 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 24: >= 50% reduction	37.1 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 24: >= 30% reduction	47.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 12: >= 50% reduction	53.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 2: >=30% reduction	70.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 2: >=50% reduction	50.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 4: >=30% reduction	72.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 4: >=50% reduction	59.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 8: >=30% reduction	66.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 8: >= 50% reduction	48.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 12: >= 30% reduction	65.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 16: >= 30% reduction	63.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 16: >= 50% reduction	50.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 24: >= 30% reduction	57.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 24: >= 50% reduction	46.0 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 8: >= 50% reduction	52.9 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 8: >=30% reduction	68.4 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 2: >=30% reduction	58.3 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 16: >= 50% reduction	46.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 4: >=50% reduction	56.4 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 4: >=30% reduction	70.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 24: >= 50% reduction	44.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 24: >= 30% reduction	57.1 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 12: >= 50% reduction	59.0 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 12: >= 30% reduction	64.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 2: >=50% reduction	44.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward	Week 16: >= 30% reduction	61.5 Percentage of participants

Secondary

Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities 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 osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Percentage of participants with \>=30% or \>=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.

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

Population: mITT analysis set: 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 1021. LOCF method was used to impute missing values.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16 >= 50% Reduction	28.6 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24 >= 50% Reduction	23.4 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12 >= 50% Reduction	27.9 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2 >= 30% Reduction	38.3 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16 >= 30% Reduction	41.6 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4 >= 30% 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4 >= 50% Reduction	24.7 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2 >= 50% Reduction	26.0 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24 >= 30% Reduction	39.6 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8 >= 30% Reduction	38.3 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8 >= 50% Reduction	22.7 Percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12 >= 30% 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2 >= 50% Reduction	49.0 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12 >= 30% Reduction	67.5 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4 >= 50% Reduction	51.7 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16 >= 30% Reduction	64.9 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16 >= 50% Reduction	43.7 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12 >= 50% Reduction	52.3 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2 >= 30% Reduction	64.2 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8 >= 50% Reduction	41.1 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8 >= 30% Reduction	63.6 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4 >= 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24 >= 50% Reduction	43.7 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24 >= 30% Reduction	60.9 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12 >= 50% Reduction	58.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2 >= 30% Reduction	70.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2 >= 50% Reduction	50.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4 >= 30% Reduction	74.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4 >= 50% Reduction	59.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8 >= 30% Reduction	69.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8 >= 50% Reduction	50.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12 >= 30% Reduction	72.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16 >= 30% Reduction	69.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16 >= 50% Reduction	54.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24 >= 30% Reduction	68.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24 >= 50% Reduction	52.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8 >= 50% Reduction	54.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 8 >= 30% Reduction	71.8 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2 >= 30% Reduction	58.3 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16 >= 50% Reduction	53.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4 >= 50% Reduction	57.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 4 >= 30% Reduction	73.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24 >= 50% Reduction	51.9 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 24 >= 30% Reduction	71.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12 >= 50% Reduction	66.0 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 12 >= 30% Reduction	75.6 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 2 >= 50% Reduction	44.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Week 16 >= 30% Reduction	72.4 Percentage of participants

Secondary

Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score 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. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, 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 at Week 16 were reported.

Time frame: Baseline, Week 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0%	44.8 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=10%	40.9 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=20%	36.4 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=30%	32.5 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=40%	29.2 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=50%	26.0 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=60%	19.5 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=70%	13.6 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=80%	11.0 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=90%	4.5 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=20%	58.9 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=80%	21.9 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=30%	56.3 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=40%	50.3 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=50%	39.7 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=60%	35.8 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=90%	13.2 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=70%	28.5 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0%	68.2 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=10%	64.9 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=70%	36.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=60%	43.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=90%	18.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0%	78.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=30%	63.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=50%	50.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=80%	25.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=10%	73.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=40%	54.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=20%	66.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=40%	53.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=70%	35.3 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=50%	46.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=90%	20.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=60%	39.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=10%	70.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=20%	67.3 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=30%	61.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0%	72.4 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)	>=80%	30.1 Percentage of participants

Secondary

Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: 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 osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, 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 at Week 16 were reported.

Time frame: Baseline, Week 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=60%	21.4 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=40%	34.4 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=20%	50.6 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=80%	11.0 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=30%	41.6 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=70%	14.3 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=90%	4.5 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=50%	28.6 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>0%	79.2 Percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=10%	63.6 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=60%	37.7 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=90%	13.2 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=70%	29.1 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=20%	70.2 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=40%	57.0 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=30%	64.9 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=10%	81.5 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=80%	21.9 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>0%	87.4 Percentage of participants
Tanezumab 2.5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=50%	43.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=10%	82.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=70%	40.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=80%	28.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=90%	20.0 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>0%	89.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=60%	47.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=20%	74.7 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=30%	69.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=40%	59.3 Percentage of participants
Tanezumab 5 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=50%	54.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=10%	89.7 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>0%	93.6 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=70%	40.4 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=40%	61.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=90%	23.1 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=80%	34.6 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=60%	45.5 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=20%	81.4 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=50%	53.2 Percentage of participants
Tanezumab 10 mg	Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)	>=30%	72.4 Percentage of participants

Secondary

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

A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (\>=) 50 percent (%)and absolute change of \>=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], 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	45.5 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	45.5 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	43.5 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	39.6 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 16	35.1 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 24	30.5 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	50.7 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 12	63.3 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 2	68.7 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 8	60.7 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 4	71.3 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 16	57.3 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	79.3 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	70.7 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	70.0 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 24	62.0 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 16	65.3 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	80.0 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	65.8 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	58.7 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	74.8 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 12	66.5 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 2	67.7 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	71.0 Percentage of participants

Secondary

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

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 2	45.5 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	48.1 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 8	47.4 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	50.0 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 16	48.1 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 24	46.1 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	66.7 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	74.0 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	68.7 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 8	66.7 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 4	73.3 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 16	68.7 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	81.3 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 8	75.3 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	78.0 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	73.3 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 16	72.0 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 2	80.0 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	77.4 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	74.2 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	78.7 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 12	78.1 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 2	67.7 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 8	75.5 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: Feb 27, 2026

Tanezumab in Osteoarthritis Of The Hip

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

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 Score at Week 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score 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 and 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 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24

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

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

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

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

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

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

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

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

Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Duration of Rescue Medication Use

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Percentage of Participants Who Used Rescue Medication

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward

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

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

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