Trial Outcomes & Findings for Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee (NCT NCT02528188)

Last Updated: 2020-01-10

Results Overview

Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to \[\>=\] 2 millimeters \[mm\]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3021 participants

Primary outcome timeframe

Baseline up to Week 80

Results posted on

2020-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Overall Study STARTED	1008	1005	1008
Overall Study Treated	1002	998	996
Overall Study COMPLETED	741	729	757
Overall Study NOT COMPLETED	267	276	251

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Overall Study Adverse Event	23	22	8
Overall Study Protocol Violation	4	6	4
Overall Study Lack of Efficacy	19	21	22
Overall Study Withdrawal by Subject	97	104	100
Overall Study Lost to Follow-up	25	21	31
Overall Study Death	4	4	0
Overall Study Other	89	91	74
Overall Study Randomized but not treated	6	7	12

Baseline Characteristics

Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.	Total n=2996 Participants Total of all reporting groups
Age, Continuous	60.30 years STANDARD_DEVIATION 9.17 • n=5 Participants	61.15 years STANDARD_DEVIATION 9.57 • n=7 Participants	60.25 years STANDARD_DEVIATION 9.46 • n=5 Participants	60.57 years STANDARD_DEVIATION 9.41 • n=4 Participants
Sex: Female, Male Female	637 Participants n=5 Participants	654 Participants n=7 Participants	662 Participants n=5 Participants	1953 Participants n=4 Participants
Sex: Female, Male Male	365 Participants n=5 Participants	344 Participants n=7 Participants	334 Participants n=5 Participants	1043 Participants n=4 Participants
Race/Ethnicity, Customized White	705 Participants n=5 Participants	712 Participants n=7 Participants	680 Participants n=5 Participants	2097 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	166 Participants n=5 Participants	162 Participants n=7 Participants	186 Participants n=5 Participants	514 Participants n=4 Participants
Race/Ethnicity, Customized Asian	110 Participants n=5 Participants	95 Participants n=7 Participants	99 Participants n=5 Participants	304 Participants n=4 Participants
Race/Ethnicity, Customized Other	21 Participants n=5 Participants	29 Participants n=7 Participants	31 Participants n=5 Participants	81 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome	3.9 percentage of participants Interval 2.8 to 5.3	7.1 percentage of participants Interval 5.6 to 8.9	1.5 percentage of participants Interval 0.8 to 2.5

PRIMARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome	38.3 events per 1000 participant-years Interval 28.0 to 52.5	71.5 events per 1000 participant-years Interval 56.7 to 90.2	14.8 events per 1000 participant-years Interval 8.9 to 24.6

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16	-3.22 units on a scale Standard Error 0.11	-3.33 units on a scale Standard Error 0.11	-3.07 units on a scale Standard Error 0.11

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16	-3.27 units on a scale Standard Error 0.11	-3.39 units on a scale Standard Error 0.11	-3.08 units on a scale Standard Error 0.11

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16	-0.96 units on a scale Standard Error 0.04	-0.97 units on a scale Standard Error 0.04	-0.94 units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome	1.0 percentage of participants Interval 0.5 to 1.8	2.2 percentage of participants Interval 1.4 to 3.3	0.5 percentage of participants Interval 0.2 to 1.2

SECONDARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome	9.7 events per 1000 participant-years Interval 5.2 to 18.1	21.8 events per 1000 participant-years Interval 14.4 to 33.1	4.9 events per 1000 participant-years Interval 2.1 to 11.8

SECONDARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW \>=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants With Individual Adjudicated Joint Safety Outcome Rapidly Progressive OA Type 1 or 2	3.2 percentage of participants Interval 2.2 to 4.5	6.3 percentage of participants Interval 4.9 to 8.0	1.2 percentage of participants Interval 0.6 to 2.1
Percentage of Participants With Individual Adjudicated Joint Safety Outcome Rapidly Progressive OA type 1	2.9 percentage of participants Interval 1.9 to 4.1	4.9 percentage of participants Interval 3.7 to 6.4	1.1 percentage of participants Interval 0.6 to 2.0
Percentage of Participants With Individual Adjudicated Joint Safety Outcome Rapidly Progressive OA type 2	0.3 percentage of participants Interval 0.1 to 0.9	1.4 percentage of participants Interval 0.8 to 2.3	0.1 percentage of participants Interval 0.0 to 0.6
Percentage of Participants With Individual Adjudicated Joint Safety Outcome Primary Osteonecrosis	0.1 percentage of participants Interval 0.0 to 0.6	0.1 percentage of participants Interval 0.0 to 0.6	0 percentage of participants Interval 0.0 to 0.4
Percentage of Participants With Individual Adjudicated Joint Safety Outcome Pathological Fracture	0 percentage of participants Interval 0.0 to 0.4	0 percentage of participants Interval 0.0 to 0.4	0 percentage of participants Interval 0.0 to 0.4
Percentage of Participants With Individual Adjudicated Joint Safety Outcome Subchondral Insufficiency Fracture	0.6 percentage of participants Interval 0.2 to 1.3	0.7 percentage of participants Interval 0.3 to 1.4	0.4 percentage of participants Interval 0.1 to 1.0

SECONDARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome Rapidly Progressive OA Type 1 or 2	31.4 events per 1000 participant-years Interval 22.2 to 44.4	63.3 events per 1000 participant-years Interval 49.5 to 81.1	11.9 events per 1000 participant-years Interval 6.7 to 20.9
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome Rapidly Progressive OA Type 1	28.4 events per 1000 participant-years Interval 19.8 to 40.9	49.1 events per 1000 participant-years Interval 37.1 to 65.0	10.9 events per 1000 participant-years Interval 6.0 to 19.6
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome Rapidly Progressive OA Type 2	2.9 events per 1000 participant-years Interval 0.9 to 9.1	13.9 events per 1000 participant-years Interval 8.2 to 23.4	1.0 events per 1000 participant-years Interval 0.1 to 7.0
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome Primary Osteonecrosis	1.0 events per 1000 participant-years Interval 0.1 to 6.9	1.0 events per 1000 participant-years Interval 0.1 to 7.0	0 events per 1000 participant-years 95% CI was not estimable since no participants had events.
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome Pathological Fracture	0 events per 1000 participant-years 95% CI was not estimable since no participants had events.	0 events per 1000 participant-years 95% CI was not estimable since no participants had events.	0 events per 1000 participant-years 95% CI was not estimable since no participants had events.
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome Subchondral Insufficiency Fracture	5.8 events per 1000 participant-years Interval 2.6 to 13.0	6.9 events per 1000 participant-years Interval 3.3 to 14.5	3.9 events per 1000 participant-years Interval 1.5 to 10.5

SECONDARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome	8.6 percentage of participants Interval 6.9 to 10.5	13.1 percentage of participants Interval 11.1 to 15.4	3.7 percentage of participants Interval 2.6 to 5.1

SECONDARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome	84.9 events per 1000 participant-years Interval 68.7 to 104.9	132.5 events per 1000 participant-years Interval 111.7 to 157.3	36.7 events per 1000 participant-years Interval 26.6 to 50.6

SECONDARY outcome

Timeframe: Baseline, Weeks 56 and 80

Population: Safety population included all participants treated with tanezumab or placebo SC. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure, and "Number analyzed" signifies those participants who were evaluable at specified time point for each arm, respectively.

Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 \[no radiographic features of OA\], 1 \[doubtful joint space narrowing (JSN) and possible osteophytic lipping\], 2 \[definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph\], 3 \[multiple osteophytes, definite JSN, sclerosis, possible bony deformity\], 4 \[large osteophytes, marked JSN, severe sclerosis and definite bony deformity\]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral).

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=651 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=668 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=695 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Change in Medial JSW at Week 56	-0.25 millimeter Standard Error 0.03	-0.34 millimeter Standard Error 0.03	-0.19 millimeter Standard Error 0.03
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Change in Medial JSW at Week 80	-0.33 millimeter Standard Error 0.04	-0.37 millimeter Standard Error 0.04	-0.25 millimeter Standard Error 0.03
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Change in Lateral JSW at Week 56	-0.26 millimeter Standard Error 0.07	-0.32 millimeter Standard Error 0.07	-0.27 millimeter Standard Error 0.07
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Change in Lateral JSW at Week 80	-0.46 millimeter Standard Error 0.08	-0.32 millimeter Standard Error 0.09	-0.37 millimeter Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline, Weeks 56 and 80

Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=123 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=132 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=120 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Change at Week 56	-0.35 millimeter Standard Error 0.06	-0.40 millimeter Standard Error 0.06	-0.21 millimeter Standard Error 0.06
Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Change at Week 80	-0.46 millimeter Standard Error 0.07	-0.35 millimeter Standard Error 0.07	-0.28 millimeter Standard Error 0.07

SECONDARY outcome

Timeframe: Weeks 56 and 80

Progression of OA according to Bland-Altman as defined by a decrease JSW \>=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 \[no radiographic features of OA\], 1 \[doubtful joint space narrowing (JSN) and possible osteophytic lipping\], 2 \[definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph\], 3 \[multiple osteophytes, definite JSN, sclerosis, possible bony deformity\], 4 \[large osteophytes, marked JSN, severe sclerosis and definite bony deformity\]. Higher grade indicating worse knee function.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=651 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=668 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=695 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Decreased medial JSW at Week 56	33 Participants	43 Participants	20 Participants
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Decreased medial JSW at Week 80	29 Participants	38 Participants	16 Participants
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Decreased lateral JSW at Week 56	5 Participants	8 Participants	9 Participants
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Decreased lateral JSW at Week 80	9 Participants	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Weeks 56 and 80

Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW \>=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=123 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=132 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=120 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Week 56	10 Participants	10 Participants	3 Participants
Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Week 80	9 Participants	9 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo).

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 2	-1.65 units on scale Standard Error 0.08	-1.49 units on scale Standard Error 0.08	-1.55 units on scale Standard Error 0.08
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 4	-2.25 units on scale Standard Error 0.09	-2.29 units on scale Standard Error 0.09	-1.98 units on scale Standard Error 0.09
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 8	-2.41 units on scale Standard Error 0.10	-2.65 units on scale Standard Error 0.10	-2.27 units on scale Standard Error 0.10
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 24	-2.73 units on scale Standard Error 0.13	-2.86 units on scale Standard Error 0.13	-2.67 units on scale Standard Error 0.13
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 32	-2.64 units on scale Standard Error 0.13	-2.68 units on scale Standard Error 0.13	-2.57 units on scale Standard Error 0.13
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 40	-2.56 units on scale Standard Error 0.13	-2.57 units on scale Standard Error 0.13	-2.52 units on scale Standard Error 0.13
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 48	-2.54 units on scale Standard Error 0.13	-2.48 units on scale Standard Error 0.13	-2.47 units on scale Standard Error 0.13
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 56	-2.44 units on scale Standard Error 0.13	-2.37 units on scale Standard Error 0.13	-2.42 units on scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in WOMAC Pain Subscale at Week 64 Baseline	7.01 units on a scale Standard Deviation 1.12	7.02 units on a scale Standard Deviation 1.12	6.96 units on a scale Standard Deviation 1.08
Change From Baseline in WOMAC Pain Subscale at Week 64 Change at Week 64	-3.47 units on a scale Standard Deviation 2.45	-3.12 units on a scale Standard Deviation 2.40	-3.85 units on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo).

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 2	-1.76 units on a scale Standard Error 0.08	-1.64 units on a scale Standard Error 0.08	-1.55 units on a scale Standard Error 0.08
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 4	-2.29 units on a scale Standard Error 0.09	-2.31 units on a scale Standard Error 0.09	-1.96 units on a scale Standard Error 0.09
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 8	-2.46 units on a scale Standard Error 0.10	-2.69 units on a scale Standard Error 0.10	-2.27 units on a scale Standard Error 0.10
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 24	-2.78 units on a scale Standard Error 0.13	-2.88 units on a scale Standard Error 0.13	-2.66 units on a scale Standard Error 0.13
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 32	-2.66 units on a scale Standard Error 0.13	-2.67 units on a scale Standard Error 0.13	-2.55 units on a scale Standard Error 0.13
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 40	-2.56 units on a scale Standard Error 0.13	-2.57 units on a scale Standard Error 0.13	-2.50 units on a scale Standard Error 0.13
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 48	-2.56 units on a scale Standard Error 0.14	-2.49 units on a scale Standard Error 0.13	-2.45 units on a scale Standard Error 0.13
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 56	-2.45 units on a scale Standard Error 0.14	-2.36 units on a scale Standard Error 0.13	-2.41 units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline, Week 64

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in WOMAC Physical Function Subscale at Week 64 Baseline	7.09 units on a scale Standard Deviation 1.07	7.08 units on a scale Standard Deviation 1.11	6.99 units on a scale Standard Deviation 1.09
Change From Baseline in WOMAC Physical Function Subscale at Week 64 Change at Week 64	-3.42 units on a scale Standard Deviation 2.40	-3.12 units on a scale Standard Deviation 2.41	-3.81 units on a scale Standard Deviation 2.12

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 2	-0.67 units on a scale Standard Error 0.03	-0.67 units on a scale Standard Error 0.03	-0.63 units on a scale Standard Error 0.03
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 4	-0.81 units on a scale Standard Error 0.03	-0.84 units on a scale Standard Error 0.03	-0.69 units on a scale Standard Error 0.03
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 8	-0.77 units on a scale Standard Error 0.03	-0.85 units on a scale Standard Error 0.03	-0.76 units on a scale Standard Error 0.03
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 24	-0.74 units on a scale Standard Error 0.05	-0.79 units on a scale Standard Error 0.05	-0.74 units on a scale Standard Error 0.05
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 32	-0.72 units on a scale Standard Error 0.05	-0.71 units on a scale Standard Error 0.05	-0.72 units on a scale Standard Error 0.05
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 40	-0.70 units on a scale Standard Error 0.05	-0.69 units on a scale Standard Error 0.05	-0.69 units on a scale Standard Error 0.05
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 48	-0.70 units on a scale Standard Error 0.05	-0.66 units on a scale Standard Error 0.05	-0.67 units on a scale Standard Error 0.05
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Change at Week 56	-0.65 units on a scale Standard Error 0.05	-0.60 units on a scale Standard Error 0.05	-0.66 units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 Baseline	3.49 units on a scale Standard Deviation 0.61	3.46 units on a scale Standard Deviation 0.60	3.44 units on a scale Standard Deviation 0.59
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 Change at Week 64	-0.79 units on a scale Standard Deviation 0.96	-0.64 units on a scale Standard Deviation 0.98	-0.95 units on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). "Number analyzed"=participants who were evaluable for this outcome measure at specified time points.

Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was \>=50 percent and \>= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and PGA of OA (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2	46.7 percentage of participants	43.7 percentage of participants	44.8 percentage of participants
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4	62.6 percentage of participants	62.7 percentage of participants	56.4 percentage of participants
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8	67.5 percentage of participants	70.3 percentage of participants	64.4 percentage of participants
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16	78.2 percentage of participants	78.3 percentage of participants	75.1 percentage of participants
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24	62.4 percentage of participants	64.8 percentage of participants	61.3 percentage of participants
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32	59.2 percentage of participants	59.9 percentage of participants	58.6 percentage of participants
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40	58.4 percentage of participants	58.7 percentage of participants	58.2 percentage of participants
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48	57.4 percentage of participants	56.2 percentage of participants	57.3 percentage of participants
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56	56.5 percentage of participants	54.5 percentage of participants	56.0 percentage of participants
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64	79.2 percentage of participants	75.2 percentage of participants	86.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

Percentage of participants with reduction in WOMAC pain intensity of \>= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2: At least 30% reduction	34.8 percentage of participants	30.5 percentage of participants	32.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2: At least 50% reduction	17.8 percentage of participants	16.5 percentage of participants	14.7 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2: At least 70% reduction	7.7 percentage of participants	7.1 percentage of participants	6.2 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2: At least 90% reduction	2.4 percentage of participants	2.5 percentage of participants	1.8 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4: At least 30% reduction	50.2 percentage of participants	49.5 percentage of participants	44.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4: At least 50% reduction	30.4 percentage of participants	30.5 percentage of participants	24.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4: At least 70% reduction	14.5 percentage of participants	16.4 percentage of participants	11.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4: At least 90% reduction	4.3 percentage of participants	4.9 percentage of participants	3.1 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8: At least 30% reduction	55.9 percentage of participants	59.0 percentage of participants	54.1 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8: At least 50% reduction	36.8 percentage of participants	39.3 percentage of participants	32.6 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8: At least 70% reduction	19.3 percentage of participants	22.4 percentage of participants	15.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8: At least 90% reduction	4.7 percentage of participants	6.6 percentage of participants	4.2 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16: At least 30% reduction	71.8 percentage of participants	72.9 percentage of participants	68.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16: At least 50% reduction	54.9 percentage of participants	56.5 percentage of participants	51.5 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16: At least 70% reduction	28.9 percentage of participants	35.0 percentage of participants	28.8 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16: At least 90% reduction	10.3 percentage of participants	12.7 percentage of participants	8.5 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24: At least 30% reduction	59.4 percentage of participants	61.1 percentage of participants	59.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24: At least 50% reduction	49.3 percentage of participants	49.4 percentage of participants	47.5 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24: At least 70% reduction	30.8 percentage of participants	33.8 percentage of participants	29.0 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24: At least 90% reduction	10.3 percentage of participants	13.3 percentage of participants	11.5 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32: At least 30% reduction	56.8 percentage of participants	55.7 percentage of participants	56.3 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32: At least 50% reduction	47.4 percentage of participants	45.8 percentage of participants	46.3 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32: At least 70% reduction	31.2 percentage of participants	31.5 percentage of participants	27.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32: At least 90% reduction	10.3 percentage of participants	12.9 percentage of participants	10.0 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40: At least 30% reduction	55.7 percentage of participants	54.6 percentage of participants	54.8 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40: At least 50% reduction	47.2 percentage of participants	45.2 percentage of participants	46.0 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40: At least 70% reduction	30.0 percentage of participants	30.4 percentage of participants	29.3 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40: At least 90% reduction	10.8 percentage of participants	12.0 percentage of participants	10.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48: At least 30% reduction	54.6 percentage of participants	52.9 percentage of participants	54.2 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48: At least 50% reduction	46.2 percentage of participants	43.2 percentage of participants	44.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48: At least 70% reduction	29.6 percentage of participants	29.4 percentage of participants	28.5 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48: At least 90% reduction	10.3 percentage of participants	11.4 percentage of participants	10.6 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56: At least 30% reduction	53.1 percentage of participants	51.2 percentage of participants	52.7 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56: At least 50% reduction	44.3 percentage of participants	41.5 percentage of participants	43.5 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56: At least 70% reduction	28.2 percentage of participants	27.0 percentage of participants	27.5 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56: At least 90% reduction	10.1 percentage of participants	10.5 percentage of participants	10.1 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64: At least 30% reduction	73.0 percentage of participants	69.0 percentage of participants	81.3 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64: At least 50% reduction	55.4 percentage of participants	47.3 percentage of participants	60.2 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64: At least 70% reduction	31.1 percentage of participants	24.3 percentage of participants	34.2 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64: At least 90% reduction	9.6 percentage of participants	7.9 percentage of participants	12.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure.

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than \[\>\] 0% ; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1000 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=995 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=994 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >0%	89.5 percentage of participants	87.6 percentage of participants	87.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >=10%	85.0 percentage of participants	82.8 percentage of participants	82.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >=20%	78.1 percentage of participants	78.3 percentage of participants	75.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >=30%	71.8 percentage of participants	72.9 percentage of participants	68.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >=40%	63.7 percentage of participants	63.5 percentage of participants	59.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >=50%	54.9 percentage of participants	56.5 percentage of participants	51.5 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >=60%	40.9 percentage of participants	44.8 percentage of participants	38.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >=70%	28.9 percentage of participants	35.0 percentage of participants	28.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >=80%	19.4 percentage of participants	23.9 percentage of participants	18.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: >=90%	10.3 percentage of participants	12.7 percentage of participants	8.5 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 16: =100%	4.4 percentage of participants	3.9 percentage of participants	3.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >0%	66.7 percentage of participants	68.2 percentage of participants	64.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >=10%	64.9 percentage of participants	66.4 percentage of participants	63.4 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >=20%	62.2 percentage of participants	65.2 percentage of participants	62.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >=30%	59.4 percentage of participants	61.1 percentage of participants	59.4 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >=40%	55.2 percentage of participants	55.7 percentage of participants	54.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >=50%	49.3 percentage of participants	49.4 percentage of participants	47.5 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >=60%	40.7 percentage of participants	41.2 percentage of participants	38.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >=70%	30.8 percentage of participants	33.8 percentage of participants	29.0 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >=80%	20.6 percentage of participants	24.0 percentage of participants	20.2 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: >=90%	10.3 percentage of participants	13.3 percentage of participants	11.5 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 24: =100%	3.9 percentage of participants	4.5 percentage of participants	3.4 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >0%	60.8 percentage of participants	59.1 percentage of participants	59.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >=10%	59.1 percentage of participants	57.0 percentage of participants	58.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >=20%	55.9 percentage of participants	54.8 percentage of participants	56.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >=30%	53.1 percentage of participants	51.2 percentage of participants	52.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >=40%	48.6 percentage of participants	46.8 percentage of participants	48.6 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >=50%	44.3 percentage of participants	41.5 percentage of participants	43.5 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >=60%	37.0 percentage of participants	33.8 percentage of participants	36.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >=70%	28.2 percentage of participants	27.0 percentage of participants	27.5 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >=80%	18.9 percentage of participants	19.1 percentage of participants	18.6 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: >=90%	10.1 percentage of participants	10.5 percentage of participants	10.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Week 56: =100%	4.5 percentage of participants	5.3 percentage of participants	4.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). "Overall number of participants analyzed" = participants who were evaluable for this outcome measure. "Number analyzed"=participants who were evaluable for this outcome measure at specified time points.

Percentage of participants with reduction in WOMAC physical function of \>=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1000 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=995 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=994 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2: At least 30% reduction	35.8 percentage of participants	32.1 percentage of participants	31.7 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2: At least 50% reduction	20.0 percentage of participants	17.0 percentage of participants	15.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2: At least 70% reduction	8.3 percentage of participants	8.2 percentage of participants	5.8 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2: At least 90% reduction	2.1 percentage of participants	3.2 percentage of participants	1.7 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4: At least 30% reduction	49.0 percentage of participants	49.1 percentage of participants	43.2 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4: At least 50% reduction	31.1 percentage of participants	31.3 percentage of participants	23.1 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4: At least 70% reduction	15.5 percentage of participants	15.8 percentage of participants	11.2 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4: At least 90% reduction	4.6 percentage of participants	5.4 percentage of participants	2.6 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8: At least 30% reduction	56.0 percentage of participants	59.5 percentage of participants	55.0 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8: At least 50% reduction	36.6 percentage of participants	40.0 percentage of participants	31.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8: At least 70% reduction	18.7 percentage of participants	21.3 percentage of participants	14.1 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8: At least 90% reduction	5.8 percentage of participants	7.1 percentage of participants	4.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16: At least 30% reduction	71.6 percentage of participants	71.8 percentage of participants	68.1 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16: At least 50% reduction	53.1 percentage of participants	55.8 percentage of participants	50.1 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16: At least 70% reduction	29.9 percentage of participants	34.3 percentage of participants	27.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16: At least 90% reduction	10.7 percentage of participants	13.4 percentage of participants	9.7 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24: At least 30% reduction	59.5 percentage of participants	61.3 percentage of participants	59.0 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24: At least 50% reduction	49.9 percentage of participants	48.2 percentage of participants	46.8 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24: At least 70% reduction	30.4 percentage of participants	32.7 percentage of participants	27.8 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24: At least 90% reduction	11.0 percentage of participants	13.0 percentage of participants	9.8 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32: At least 30% reduction	56.7 percentage of participants	56.6 percentage of participants	55.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32: At least 50% reduction	47.2 percentage of participants	45.7 percentage of participants	44.7 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32: At least 70% reduction	29.7 percentage of participants	30.2 percentage of participants	26.8 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32: At least 90% reduction	11.0 percentage of participants	13.1 percentage of participants	9.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40: At least 30% reduction	55.5 percentage of participants	55.5 percentage of participants	54.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40: At least 50% reduction	45.5 percentage of participants	45.0 percentage of participants	45.0 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40: At least 70% reduction	29.5 percentage of participants	29.1 percentage of participants	27.6 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40: At least 90% reduction	10.3 percentage of participants	13.2 percentage of participants	9.5 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48: At least 30% reduction	54.5 percentage of participants	53.3 percentage of participants	54.6 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48: At least 50% reduction	45.3 percentage of participants	43.5 percentage of participants	43.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48: At least 70% reduction	29.1 percentage of participants	27.9 percentage of participants	26.1 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48: At least 90% reduction	10.2 percentage of participants	12.0 percentage of participants	9.4 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56: At least 30% reduction	52.0 percentage of participants	51.1 percentage of participants	52.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56: At least 50% reduction	44.1 percentage of participants	41.3 percentage of participants	42.5 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56: At least 70% reduction	26.9 percentage of participants	26.4 percentage of participants	26.0 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56: At least 90% reduction	9.3 percentage of participants	10.5 percentage of participants	9.0 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64: At least 30% reduction	71.4 percentage of participants	68.0 percentage of participants	78.2 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64: At least 50% reduction	52.9 percentage of participants	44.6 percentage of participants	58.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64: At least 70% reduction	31.4 percentage of participants	22.9 percentage of participants	33.9 percentage of participants
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64: At least 90% reduction	9.4 percentage of participants	7.9 percentage of participants	13.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure.

Percentage of participants with cumulative reduction (as percent) (\> 0 %; \>= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1000 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=995 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=994 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: =100%	3.0 percentage of participants	3.2 percentage of participants	2.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >0%	61.1 percentage of participants	59.5 percentage of participants	60.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >=10%	59.3 percentage of participants	57.3 percentage of participants	57.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >=20%	56.1 percentage of participants	54.3 percentage of participants	55.4 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >=30%	52.0 percentage of participants	51.1 percentage of participants	52.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >=40%	48.5 percentage of participants	46.3 percentage of participants	48.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >=50%	44.1 percentage of participants	41.3 percentage of participants	42.5 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >=60%	36.7 percentage of participants	34.6 percentage of participants	34.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >=70%	26.9 percentage of participants	26.4 percentage of participants	26.0 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >=80%	17.1 percentage of participants	17.1 percentage of participants	17.4 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: >=90%	9.3 percentage of participants	10.5 percentage of participants	9.0 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 56: =100%	2.9 percentage of participants	3.6 percentage of participants	3.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >0%	90.0 percentage of participants	88.8 percentage of participants	87.4 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >=10%	85.0 percentage of participants	83.9 percentage of participants	81.4 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >=20%	78.4 percentage of participants	77.3 percentage of participants	73.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >=30%	71.6 percentage of participants	71.8 percentage of participants	68.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >=40%	63.7 percentage of participants	64.1 percentage of participants	61.0 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >=50%	53.1 percentage of participants	55.8 percentage of participants	50.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >=60%	41.4 percentage of participants	44.7 percentage of participants	39.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >=70%	29.9 percentage of participants	34.3 percentage of participants	27.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >=80%	20.8 percentage of participants	24.4 percentage of participants	17.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: >=90%	10.7 percentage of participants	13.4 percentage of participants	9.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 16: =100%	2.9 percentage of participants	3.3 percentage of participants	2.0 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >0%	66.7 percentage of participants	68.6 percentage of participants	65.0 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >=10%	65.0 percentage of participants	66.6 percentage of participants	63.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >=20%	62.6 percentage of participants	64.2 percentage of participants	60.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >=30%	59.5 percentage of participants	61.3 percentage of participants	59.0 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >=40%	54.9 percentage of participants	56.0 percentage of participants	53.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >=50%	49.9 percentage of participants	48.2 percentage of participants	46.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >=60%	41.3 percentage of participants	42.0 percentage of participants	37.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >=70%	30.4 percentage of participants	32.7 percentage of participants	27.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >=80%	19.9 percentage of participants	22.6 percentage of participants	18.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Week 24: >=90%	11.0 percentage of participants	13.0 percentage of participants	9.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). "Overall number of participants analyzed" = participants who were evaluable for this outcome measure. "Number analyzed"=participants who were evaluable for this outcome measure at specified time points.

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1000 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=995 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=994 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 2	14.6 percentage of participants	15.6 percentage of participants	11.6 percentage of participants
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 4	21.4 percentage of participants	22.4 percentage of participants	15.9 percentage of participants
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 8	21.9 percentage of participants	23.7 percentage of participants	19.0 percentage of participants
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 16	29.1 percentage of participants	30.3 percentage of participants	28.2 percentage of participants
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 24	23.4 percentage of participants	24.8 percentage of participants	23.7 percentage of participants
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 32	23.7 percentage of participants	22.3 percentage of participants	23.6 percentage of participants
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 40	21.7 percentage of participants	21.7 percentage of participants	21.0 percentage of participants
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 48	22.0 percentage of participants	21.7 percentage of participants	21.1 percentage of participants
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 56	21.0 percentage of participants	19.7 percentage of participants	20.8 percentage of participants
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Week 64	21.1 percentage of participants	17.4 percentage of participants	25.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 1	-0.47 units on a scale Standard Error 0.05	-0.56 units on a scale Standard Error 0.05	-0.56 units on a scale Standard Error 0.05
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 2	-1.02 units on a scale Standard Error 0.07	-0.97 units on a scale Standard Error 0.07	-0.91 units on a scale Standard Error 0.07
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 3	-1.40 units on a scale Standard Error 0.08	-1.30 units on a scale Standard Error 0.08	-1.23 units on a scale Standard Error 0.08
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 4	-1.62 units on a scale Standard Error 0.09	-1.65 units on a scale Standard Error 0.09	-1.32 units on a scale Standard Error 0.09
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 6	-1.85 units on a scale Standard Error 0.09	-1.97 units on a scale Standard Error 0.09	-1.49 units on a scale Standard Error 0.09
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 8	-1.83 units on a scale Standard Error 0.10	-2.04 units on a scale Standard Error 0.10	-1.59 units on a scale Standard Error 0.10
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 10	-2.35 units on a scale Standard Error 0.10	-2.46 units on a scale Standard Error 0.10	-1.98 units on a scale Standard Error 0.10
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 12	-2.48 units on a scale Standard Error 0.10	-2.55 units on a scale Standard Error 0.10	-2.10 units on a scale Standard Error 0.10
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 16	-2.41 units on a scale Standard Error 0.10	-2.52 units on a scale Standard Error 0.10	-2.17 units on a scale Standard Error 0.11
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 20	-2.56 units on a scale Standard Error 0.11	-2.60 units on a scale Standard Error 0.11	-2.27 units on a scale Standard Error 0.11
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 24	-2.35 units on a scale Standard Error 0.13	-2.41 units on a scale Standard Error 0.12	-2.11 units on a scale Standard Error 0.12
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 32	-2.27 units on a scale Standard Error 0.13	-2.26 units on a scale Standard Error 0.13	-2.06 units on a scale Standard Error 0.13
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 40	-2.25 units on a scale Standard Error 0.13	-2.20 units on a scale Standard Error 0.13	-2.07 units on a scale Standard Error 0.13
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 48	-2.20 units on a scale Standard Error 0.13	-2.10 units on a scale Standard Error 0.13	-2.03 units on a scale Standard Error 0.13
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Change at Week 56	-2.17 units on a scale Standard Error 0.13	-2.03 units on a scale Standard Error 0.13	-2.04 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline, Week 64

Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Average Pain Score in the Index Joint at Week 64 Baseline	6.76 units on a scale Standard Deviation 1.59	6.77 units on a scale Standard Deviation 1.58	6.76 units on a scale Standard Deviation 1.54
Change From Baseline in Average Pain Score in the Index Joint at Week 64 Change at Week 64	-3.01 units on a scale Standard Deviation 2.60	-2.81 units on a scale Standard Deviation 2.71	-3.24 units on a scale Standard Deviation 2.55

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 2	-1.79 units on a scale Standard Error 0.09	-1.70 units on a scale Standard Error 0.09	-1.48 units on a scale Standard Error 0.09
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 4	-2.32 units on a scale Standard Error 0.10	-2.43 units on a scale Standard Error 0.10	-1.95 units on a scale Standard Error 0.10
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 8	-2.46 units on a scale Standard Error 0.10	-2.79 units on a scale Standard Error 0.10	-2.16 units on a scale Standard Error 0.10
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 16	-3.32 units on a scale Standard Error 0.11	-3.54 units on a scale Standard Error 0.11	-3.10 units on a scale Standard Error 0.11
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 24	-2.77 units on a scale Standard Error 0.13	-2.95 units on a scale Standard Error 0.13	-2.63 units on a scale Standard Error 0.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 32	-2.68 units on a scale Standard Error 0.13	-2.74 units on a scale Standard Error 0.13	-2.52 units on a scale Standard Error 0.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 40	-2.58 units on a scale Standard Error 0.14	-2.64 units on a scale Standard Error 0.14	-2.46 units on a scale Standard Error 0.14
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 48	-2.60 units on a scale Standard Error 0.14	-2.54 units on a scale Standard Error 0.13	-2.44 units on a scale Standard Error 0.14
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 56	-2.46 units on a scale Standard Error 0.14	-2.46 units on a scale Standard Error 0.14	-2.42 units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline, Week 64

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 Baseline	7.15 units on a scale Standard Deviation 1.42	7.20 units on a scale Standard Deviation 1.40	7.09 units on a scale Standard Deviation 1.42
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 Change at Week 64	-3.31 units on a scale Standard Deviation 2.72	-3.04 units on a scale Standard Deviation 2.64	-3.66 units on a scale Standard Deviation 2.36

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 2	-1.73 units on a scale Standard Error 0.08	-1.61 units on a scale Standard Error 0.08	-1.52 units on a scale Standard Error 0.08
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 4	-2.28 units on a scale Standard Error 0.09	-2.34 units on a scale Standard Error 0.09	-1.95 units on a scale Standard Error 0.09
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 8	-2.44 units on a scale Standard Error 0.10	-2.71 units on a scale Standard Error 0.10	-2.23 units on a scale Standard Error 0.10
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 16	-3.26 units on a scale Standard Error 0.11	-3.41 units on a scale Standard Error 0.11	-3.07 units on a scale Standard Error 0.11
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 24	-2.74 units on a scale Standard Error 0.13	-2.88 units on a scale Standard Error 0.13	-2.64 units on a scale Standard Error 0.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 32	-2.65 units on a scale Standard Error 0.13	-2.69 units on a scale Standard Error 0.13	-2.54 units on a scale Standard Error 0.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 40	-2.57 units on a scale Standard Error 0.13	-2.58 units on a scale Standard Error 0.13	-2.49 units on a scale Standard Error 0.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 48	-2.56 units on a scale Standard Error 0.13	-2.48 units on a scale Standard Error 0.13	-2.44 units on a scale Standard Error 0.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 56	-2.45 units on a scale Standard Error 0.13	-2.38 units on a scale Standard Error 0.13	-2.40 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline, Week 64

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 Baseline	7.09 units on a scale Standard Deviation 1.08	7.10 units on a scale Standard Deviation 1.10	7.01 units on a scale Standard Deviation 1.08
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 Change at Week 64	-3.40 units on a scale Standard Deviation 2.40	-3.09 units on a scale Standard Deviation 2.37	-3.77 units on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 2	-1.54 units on a scale Standard Error 0.08	-1.39 units on a scale Standard Error 0.08	-1.46 units on a scale Standard Error 0.08
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 4	-2.14 units on a scale Standard Error 0.10	-2.15 units on a scale Standard Error 0.10	-1.91 units on a scale Standard Error 0.10
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 8	-2.26 units on a scale Standard Error 0.10	-2.47 units on a scale Standard Error 0.10	-2.22 units on a scale Standard Error 0.10
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 16	-3.01 units on a scale Standard Error 0.11	-3.13 units on a scale Standard Error 0.11	-2.95 units on a scale Standard Error 0.11
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 24	-2.64 units on a scale Standard Error 0.13	-2.76 units on a scale Standard Error 0.13	-2.60 units on a scale Standard Error 0.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 32	-2.54 units on a scale Standard Error 0.13	-2.54 units on a scale Standard Error 0.13	-2.52 units on a scale Standard Error 0.14
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 40	-2.48 units on a scale Standard Error 0.14	-2.42 units on a scale Standard Error 0.14	-2.48 units on a scale Standard Error 0.14
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 48	-2.45 units on a scale Standard Error 0.14	-2.34 units on a scale Standard Error 0.14	-2.42 units on a scale Standard Error 0.14
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 56	-2.37 units on a scale Standard Error 0.14	-2.21 units on a scale Standard Error 0.14	-2.39 units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline, Week 64

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64 Baseline	6.86 units on a scale Standard Deviation 1.33	6.90 units on a scale Standard Deviation 1.34	6.86 units on a scale Standard Deviation 1.30
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64 Change at Week 64	-3.20 units on a scale Standard Deviation 2.78	-2.69 units on a scale Standard Deviation 2.58	-3.67 units on a scale Standard Deviation 2.32

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 2	-1.81 units on a scale Standard Error 0.08	-1.66 units on a scale Standard Error 0.08	-1.66 units on a scale Standard Error 0.09
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 4	-2.34 units on a scale Standard Error 0.10	-2.43 units on a scale Standard Error 0.10	-2.08 units on a scale Standard Error 0.10
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 8	-2.48 units on a scale Standard Error 0.10	-2.81 units on a scale Standard Error 0.10	-2.40 units on a scale Standard Error 0.10
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 16	-3.34 units on a scale Standard Error 0.11	-3.50 units on a scale Standard Error 0.11	-3.18 units on a scale Standard Error 0.12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 24	-2.89 units on a scale Standard Error 0.13	-3.03 units on a scale Standard Error 0.13	-2.83 units on a scale Standard Error 0.14
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 32	-2.76 units on a scale Standard Error 0.14	-2.84 units on a scale Standard Error 0.14	-2.74 units on a scale Standard Error 0.14
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 40	-2.69 units on a scale Standard Error 0.14	-2.74 units on a scale Standard Error 0.14	-2.70 units on a scale Standard Error 0.14
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 48	-2.70 units on a scale Standard Error 0.14	-2.63 units on a scale Standard Error 0.14	-2.67 units on a scale Standard Error 0.14
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Change at Week 56	-2.55 units on a scale Standard Error 0.14	-2.47 units on a scale Standard Error 0.14	-2.55 units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline, Week 64

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

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64 Baseline	7.89 units on a scale Standard Deviation 1.24	7.88 units on a scale Standard Deviation 1.29	7.83 units on a scale Standard Deviation 1.19
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64 Change at Week 64	-3.28 units on a scale Standard Deviation 2.67	-2.97 units on a scale Standard Deviation 2.69	-3.70 units on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: Weeks 16, 24 and 56

WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 16: Percent Work Time Missed	-2.33 units on a scale Standard Error 0.62	-3.35 units on a scale Standard Error 0.64	-2.92 units on a scale Standard Error 0.63
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 16:Percent Impairment While Working	-28.07 units on a scale Standard Error 1.58	-26.94 units on a scale Standard Error 1.61	-26.59 units on a scale Standard Error 1.60
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 16: Percent Overall Work Impairment	-28.67 units on a scale Standard Error 1.62	-27.51 units on a scale Standard Error 1.65	-27.04 units on a scale Standard Error 1.63
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 16: Percent Activity Impairment	-30.59 units on a scale Standard Error 1.04	-31.36 units on a scale Standard Error 1.04	-29.38 units on a scale Standard Error 1.05
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 24: Percent Work Time Missed	-2.70 units on a scale Standard Error 0.80	-2.19 units on a scale Standard Error 0.81	-2.73 units on a scale Standard Error 0.81
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 24:Percent Impairment While Working	-25.34 units on a scale Standard Error 1.73	-26.66 units on a scale Standard Error 1.74	-25.15 units on a scale Standard Error 1.74
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 24: Percent Overall Work Impairment	-26.05 units on a scale Standard Error 1.78	-27.33 units on a scale Standard Error 1.80	-25.90 units on a scale Standard Error 1.80
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 24: Percent Activity Impairment	-29.88 units on a scale Standard Error 1.13	-30.53 units on a scale Standard Error 1.13	-29.76 units on a scale Standard Error 1.14
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 56: Percent Work Time Missed	-0.12 units on a scale Standard Error 1.56	-1.84 units on a scale Standard Error 1.47	-0.81 units on a scale Standard Error 1.53
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 56:Percent Impairment While Working	-31.49 units on a scale Standard Error 2.22	-29.92 units on a scale Standard Error 2.12	-34.59 units on a scale Standard Error 2.17
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 56: Percent Overall Work Impairment	-31.21 units on a scale Standard Error 2.39	-29.29 units on a scale Standard Error 2.28	-34.26 units on a scale Standard Error 2.34
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Change at Week 56: Percent Activity Impairment	-34.47 units on a scale Standard Error 1.42	-32.91 units on a scale Standard Error 1.39	-36.17 units on a scale Standard Error 1.41

SECONDARY outcome

Timeframe: Baseline, Week 64

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Baseline: Percent Work Time Missed	6.1 units on a scale Standard Deviation 15.81	6.0 units on a scale Standard Deviation 15.56	5.2 units on a scale Standard Deviation 14.54
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Baseline: Percent Impairment While Working	60.5 units on a scale Standard Deviation 20.39	58.3 units on a scale Standard Deviation 20.78	59.3 units on a scale Standard Deviation 18.97
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Baseline: Percent Overall Work Impairment	62.1 units on a scale Standard Deviation 21.02	60.0 units on a scale Standard Deviation 21.37	60.6 units on a scale Standard Deviation 19.78
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Baseline: Percent Activity Impairment	68.3 units on a scale Standard Deviation 14.93	67.9 units on a scale Standard Deviation 15.83	66.7 units on a scale Standard Deviation 15.35
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Change at Week 64: Percent Work Time Missed	-1.8 units on a scale Standard Deviation 19.35	4.1 units on a scale Standard Deviation 21.88	-2.1 units on a scale Standard Deviation 16.65
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Change at Week 64:Percent Impairment While Working	-24.2 units on a scale Standard Deviation 27.69	-20.7 units on a scale Standard Deviation 29.13	-26.5 units on a scale Standard Deviation 26.24
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Change at Week 64: Percent Overall Work Impairment	-24.5 units on a scale Standard Deviation 28.77	-19.2 units on a scale Standard Deviation 30.54	-27.0 units on a scale Standard Deviation 27.22
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Change at Week 64: Percent Activity Impairment	-28.7 units on a scale Standard Deviation 26.68	-24.1 units on a scale Standard Deviation 27.80	-32.1 units on a scale Standard Deviation 24.51

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, "Number analyzed" signifies those participants who were evaluable at specified time point for each arm, respectively.

Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Baseline · No problem in walking	26 Participants	20 Participants	23 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Baseline · Slight problem in walking	203 Participants	192 Participants	194 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Baseline · Moderate problem in walking	567 Participants	579 Participants	588 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Baseline · Severe problem in walking	204 Participants	202 Participants	189 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Baseline · Unable to walk	0 Participants	2 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 8 · No problem in walking	223 Participants	241 Participants	216 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 8 · Slight problem in walking	374 Participants	411 Participants	392 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 8 · Moderate problem in walking	318 Participants	266 Participants	301 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 8 · Severe problem in walking	41 Participants	48 Participants	44 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 8 · Unable to walk	0 Participants	0 Participants	3 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 16 · No problem in walking	299 Participants	319 Participants	292 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 16 · Slight problem in walking	388 Participants	371 Participants	412 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 16 · Moderate problem in walking	199 Participants	196 Participants	185 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 16 · Severe problem in walking	27 Participants	34 Participants	26 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 16 · Unable to walk	0 Participants	0 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 24 · No problem in walking	259 Participants	261 Participants	260 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 24 · Slight problem in walking	308 Participants	310 Participants	337 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 24 · Moderate problem in walking	216 Participants	200 Participants	186 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 24 · Severe problem in walking	34 Participants	43 Participants	29 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 24 · Unable to walk	0 Participants	2 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 40 · No problem in walking	217 Participants	211 Participants	218 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 40 · Slight problem in walking	215 Participants	209 Participants	217 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 40 · Moderate problem in walking	110 Participants	106 Participants	91 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 40 · Severe problem in walking	19 Participants	27 Participants	9 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 40 · Unable to walk	0 Participants	0 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 56 · No problem in walking	157 Participants	147 Participants	170 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 56 · Slight problem in walking	205 Participants	166 Participants	189 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 56 · Moderate problem in walking	77 Participants	120 Participants	91 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 56 · Severe problem in walking	19 Participants	24 Participants	9 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 56 · Unable to walk	0 Participants	1 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 64 · No problem in walking	98 Participants	66 Participants	107 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 64 · Slight problem in walking	156 Participants	156 Participants	205 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 64 · Moderate problem in walking	150 Participants	151 Participants	121 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 64 · Severe problem in walking	45 Participants	54 Participants	21 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Week 64 · Unable to walk	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, "Number analyzed" signifies those participants who were evaluable at specified time point for each arm, respectively.

Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Baseline · No problems washing or dressing	251 Participants	242 Participants	270 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Baseline · Slight problems washing or dressing	315 Participants	295 Participants	319 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Baseline · Moderate problems washing or dressing	361 Participants	389 Participants	350 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Baseline · Severe problems washing or dressing	73 Participants	69 Participants	55 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Baseline · Unable to wash or dress	0 Participants	0 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 8 · No problems washing or dressing	551 Participants	569 Participants	542 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 8 · Slight problems washing or dressing	270 Participants	261 Participants	276 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 8 · Moderate problems washing or dressing	126 Participants	128 Participants	134 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 8 · Severe problems washing or dressing	8 Participants	8 Participants	3 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 8 · Unable to wash or dress	1 Participants	0 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 16 · No problems washing or dressing	610 Participants	597 Participants	583 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 16 · Slight problems washing or dressing	216 Participants	231 Participants	246 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 16 · Moderate problems washing or dressing	81 Participants	87 Participants	77 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 16 · Severe problems washing or dressing	6 Participants	5 Participants	9 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 16 · Unable to wash or dress	0 Participants	0 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 24 · No problems washing or dressing	504 Participants	504 Participants	527 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 24 · Slight problems washing or dressing	214 Participants	200 Participants	192 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 24 · Moderate problems washing or dressing	91 Participants	102 Participants	86 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 24 · Severe problems washing or dressing	7 Participants	9 Participants	8 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 24 · Unable to wash or dress	1 Participants	1 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 40 · No problems washing or dressing	377 Participants	359 Participants	371 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 40 · Slight problems washing or dressing	140 Participants	136 Participants	125 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 40 · Moderate problems washing or dressing	42 Participants	54 Participants	38 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 40 · Severe problems washing or dressing	1 Participants	4 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 40 · Unable to wash or dress	1 Participants	0 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 56 · No problems washing or dressing	305 Participants	294 Participants	291 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 56 · Slight problems washing or dressing	107 Participants	115 Participants	122 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 56 · Moderate problems washing or dressing	42 Participants	47 Participants	40 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 56 · Severe problems washing or dressing	3 Participants	2 Participants	5 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 56 · Unable to wash or dress	1 Participants	0 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 64 · No problems washing or dressing	233 Participants	192 Participants	264 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 64 · Slight problems washing or dressing	142 Participants	136 Participants	131 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 64 · Moderate problems washing or dressing	66 Participants	89 Participants	57 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 64 · Severe problems washing or dressing	8 Participants	11 Participants	2 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Week 64 · Unable to wash or dress	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, "Number analyzed" signifies those participants who were evaluable at specified time point for each arm, respectively.

Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Baseline · No problems doing usual activities	22 Participants	24 Participants	38 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Baseline · Slight problems doing usual activities	229 Participants	218 Participants	225 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Baseline · Moderate problems doing usual activities	538 Participants	551 Participants	561 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Baseline · Severe problems doing usual activities	208 Participants	201 Participants	169 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Baseline · Unable to do usual activities	3 Participants	1 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 8 · No problems doing usual activities	229 Participants	266 Participants	221 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 8 · Slight problems doing usual activities	402 Participants	411 Participants	426 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 8 · Moderate problems doing usual activities	292 Participants	256 Participants	274 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 8 · Severe problems doing usual activities	33 Participants	31 Participants	35 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 8 · Unable to do usual activities	0 Participants	2 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 16 · No problems doing usual activities	302 Participants	333 Participants	310 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 16 · Slight problems doing usual activities	402 Participants	382 Participants	408 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 16 · Moderate problems doing usual activities	184 Participants	182 Participants	172 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 16 · Severe problems doing usual activities	24 Participants	21 Participants	24 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 16 · Unable to do usual activities	1 Participants	2 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 24 · No problems doing usual activities	262 Participants	290 Participants	273 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 24 · Slight problems doing usual activities	353 Participants	315 Participants	344 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 24 · Moderate problems doing usual activities	174 Participants	182 Participants	166 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 24 · Severe problems doing usual activities	27 Participants	27 Participants	29 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 24 · Unable to do usual activities	1 Participants	2 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 40 · No problems doing usual activities	225 Participants	221 Participants	218 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 40 · Slight problems doing usual activities	239 Participants	213 Participants	233 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 40 · Moderate problems doing usual activities	85 Participants	97 Participants	74 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 40 · Severe problems doing usual activities	12 Participants	20 Participants	10 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 40 · Unable to do usual activities	0 Participants	2 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 56 · No problems doing usual activities	155 Participants	170 Participants	182 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 56 · Slight problems doing usual activities	211 Participants	179 Participants	199 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 56 · Moderate problems doing usual activities	79 Participants	86 Participants	69 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 56 · Severe problems doing usual activities	13 Participants	22 Participants	9 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 56 · Unable to do usual activities	0 Participants	1 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 64 · No problems doing usual activities	101 Participants	69 Participants	129 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 64 · Slight problems doing usual activities	173 Participants	163 Participants	197 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 64 · Moderate problems doing usual activities	138 Participants	155 Participants	115 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 64 · Severe problems doing usual activities	37 Participants	37 Participants	12 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Week 64 · Unable to do usual activities	1 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, "Number analyzed" signifies those participants who were evaluable at specified time point for each arm, respectively.

Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 8 · No pain or discomfort	82 Participants	102 Participants	83 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 8 · Slight pain or discomfort	433 Participants	465 Participants	434 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 8 · Moderate pain or discomfort	369 Participants	327 Participants	365 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 8 · Severe pain or discomfort	68 Participants	68 Participants	71 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 8 · Extreme pain or discomfort	4 Participants	4 Participants	3 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 16 · No pain or discomfort	128 Participants	163 Participants	131 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 16 · Slight pain or discomfort	508 Participants	482 Participants	515 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 16 · Moderate pain or discomfort	235 Participants	225 Participants	217 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 16 · Severe pain or discomfort	39 Participants	44 Participants	46 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 16 · Extreme pain or discomfort	3 Participants	6 Participants	6 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 24 · No pain or discomfort	117 Participants	148 Participants	130 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 24 · Slight pain or discomfort	413 Participants	384 Participants	413 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 24 · Moderate pain or discomfort	213 Participants	218 Participants	215 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 24 · Severe pain or discomfort	70 Participants	62 Participants	51 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 24 · Extreme pain or discomfort	4 Participants	4 Participants	4 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 40 · No pain or discomfort	97 Participants	122 Participants	110 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 40 · Slight pain or discomfort	298 Participants	264 Participants	308 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 40 · Moderate pain or discomfort	139 Participants	130 Participants	104 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 40 · Severe pain or discomfort	25 Participants	30 Participants	13 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 40 · Extreme pain or discomfort	2 Participants	7 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 56 · No pain or discomfort	76 Participants	90 Participants	85 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 56 · Slight pain or discomfort	248 Participants	211 Participants	259 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 56 · Moderate pain or discomfort	111 Participants	128 Participants	103 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 56 · Severe pain or discomfort	23 Participants	26 Participants	9 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 56 · Extreme pain or discomfort	0 Participants	3 Participants	3 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 64 · No pain or discomfort	45 Participants	35 Participants	62 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 64 · Slight pain or discomfort	169 Participants	115 Participants	191 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 64 · Moderate pain or discomfort	165 Participants	191 Participants	171 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 64 · Severe pain or discomfort	66 Participants	76 Participants	29 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Week 64 · Extreme pain or discomfort	5 Participants	11 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Baseline · No pain or discomfort	6 Participants	4 Participants	5 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Baseline · Slight pain or discomfort	81 Participants	75 Participants	86 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Baseline · Moderate pain or discomfort	548 Participants	574 Participants	588 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Baseline · Severe pain or discomfort	334 Participants	314 Participants	295 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Baseline · Extreme pain or discomfort	31 Participants	28 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, "Number analyzed" signifies those participants who were evaluable at specified time point for each arm, respectively.

Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Baseline · Not anxious or depressed	560 Participants	570 Participants	585 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Baseline · Slightly anxious or depressed	252 Participants	235 Participants	236 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Baseline · Moderately anxious or depressed	155 Participants	151 Participants	144 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Baseline · Severely anxious or depressed	28 Participants	37 Participants	26 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Baseline · Extremely anxious or depressed	5 Participants	2 Participants	3 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 8 · Not anxious or depressed	693 Participants	703 Participants	664 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 8 · Slightly anxious or depressed	189 Participants	180 Participants	206 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 8 · Moderately anxious or depressed	64 Participants	71 Participants	75 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 8 · Severely anxious or depressed	9 Participants	7 Participants	9 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 8 · Extremely anxious or depressed	1 Participants	5 Participants	2 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 16 · Not anxious or depressed	680 Participants	701 Participants	701 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 16 · Slightly anxious or depressed	170 Participants	147 Participants	151 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 16 · Moderately anxious or depressed	53 Participants	62 Participants	53 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 16 · Severely anxious or depressed	8 Participants	6 Participants	8 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 16 · Extremely anxious or depressed	2 Participants	4 Participants	2 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 24 · Not anxious or depressed	611 Participants	606 Participants	599 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 24 · Slightly anxious or depressed	147 Participants	131 Participants	144 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 24 · Moderately anxious or depressed	52 Participants	66 Participants	58 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 24 · Severely anxious or depressed	7 Participants	10 Participants	11 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 24 · Extremely anxious or depressed	0 Participants	3 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 40 · Not anxious or depressed	442 Participants	429 Participants	400 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 40 · Slightly anxious or depressed	92 Participants	82 Participants	107 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 40 · Moderately anxious or depressed	24 Participants	35 Participants	21 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 40 · Severely anxious or depressed	3 Participants	6 Participants	7 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 40 · Extremely anxious or depressed	0 Participants	1 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 56 · Not anxious or depressed	351 Participants	330 Participants	338 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 56 · Slightly anxious or depressed	88 Participants	90 Participants	86 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 56 · Moderately anxious or depressed	18 Participants	33 Participants	34 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 56 · Severely anxious or depressed	0 Participants	3 Participants	1 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 56 · Extremely anxious or depressed	1 Participants	2 Participants	0 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 64 · Not anxious or depressed	308 Participants	275 Participants	315 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 64 · Slightly anxious or depressed	104 Participants	96 Participants	100 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 64 · Moderately anxious or depressed	29 Participants	46 Participants	34 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 64 · Severely anxious or depressed	8 Participants	9 Participants	5 Participants
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Week 64 · Extremely anxious or depressed	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (\<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value Baseline	0.61 units on a scale Standard Deviation 0.14	0.61 units on a scale Standard Deviation 0.14	0.62 units on a scale Standard Deviation 0.13
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value Week 8	0.74 units on a scale Standard Deviation 0.12	0.75 units on a scale Standard Deviation 0.13	0.74 units on a scale Standard Deviation 0.13
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value Week 16	0.77 units on a scale Standard Deviation 0.12	0.78 units on a scale Standard Deviation 0.13	0.77 units on a scale Standard Deviation 0.13
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value Week 24	0.76 units on a scale Standard Deviation 0.14	0.76 units on a scale Standard Deviation 0.15	0.77 units on a scale Standard Deviation 0.14
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value Week 40	0.79 units on a scale Standard Deviation 0.13	0.78 units on a scale Standard Deviation 0.15	0.80 units on a scale Standard Deviation 0.12
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value Week 56	0.78 units on a scale Standard Deviation 0.12	0.77 units on a scale Standard Deviation 0.15	0.79 units on a scale Standard Deviation 0.12
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value Week 64	0.72 units on a scale Standard Deviation 0.15	0.69 units on a scale Standard Deviation 0.16	0.75 units on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: Weeks 16 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied\]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied\] and 1 question on 2 point scale \[0 =No, 1=Yes\]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=939 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=954 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=936 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Week 16: Effectiveness	64.26 units on a scale Standard Error 1.03	66.27 units on a scale Standard Error 1.02	61.61 units on a scale Standard Error 1.03
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Week 16: Side Effects	68.61 units on a scale Standard Error 3.20	73.32 units on a scale Standard Error 3.09	71.03 units on a scale Standard Error 3.15
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Week 16: Convenience	75.50 units on a scale Standard Error 0.80	75.78 units on a scale Standard Error 0.79	73.70 units on a scale Standard Error 0.80
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Week 16: Global Satisfaction	70.32 units on a scale Standard Error 0.99	70.69 units on a scale Standard Error 0.98	67.13 units on a scale Standard Error 0.99
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Week 56: Effectiveness	69.79 units on a scale Standard Error 1.38	67.91 units on a scale Standard Error 1.36	67.64 units on a scale Standard Error 1.38
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Week 56: Side Effects	78.62 units on a scale Standard Error 5.28	62.00 units on a scale Standard Error 4.88	71.34 units on a scale Standard Error 5.14
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Week 56: Convenience	78.03 units on a scale Standard Error 1.12	77.67 units on a scale Standard Error 1.10	76.18 units on a scale Standard Error 1.11
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Week 56: Global Satisfaction	75.31 units on a scale Standard Error 1.27	73.37 units on a scale Standard Error 1.25	73.37 units on a scale Standard Error 1.26

SECONDARY outcome

Timeframe: Weeks 16 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, "Number analyzed" signifies those participants who were evaluable at specified time point for each arm, respectively.

The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Number of participants who responded for the specified question were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 16 · Injectable prescription medicines	99 Participants	98 Participants	82 Participants
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 16 · Prescription medicines taken by mouth	611 Participants	633 Participants	647 Participants
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 16 · Surgery	7 Participants	7 Participants	9 Participants
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 16 · Prescription medicines and surgery	33 Participants	28 Participants	27 Participants
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 16 · No treatment	189 Participants	188 Participants	171 Participants
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 56 · Injectable prescription medicines	44 Participants	47 Participants	40 Participants
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 56 · Prescription medicines taken by mouth	307 Participants	296 Participants	324 Participants
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 56 · Surgery	8 Participants	4 Participants	2 Participants
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 56 · Prescription medicines and surgery	20 Participants	18 Participants	20 Participants
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Week 56 · No treatment	119 Participants	122 Participants	103 Participants

SECONDARY outcome

Timeframe: Weeks 16 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, "Number analyzed" = participants who were evaluable at specified time point for each arm, respectively.

The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product. Number of participants who responded for the specified question were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 16 · Yes, definitely prefer the study drug	577 Participants	597 Participants	531 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 16 · Slight preference for the study drug	141 Participants	169 Participants	158 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 16 · No preference either way	149 Participants	114 Participants	164 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 16 · Slight preference for my previous treatment	28 Participants	34 Participants	36 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 16 · No, definitely prefer my previous treatment	44 Participants	40 Participants	47 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 56 · Yes, definitely prefer the study drug	342 Participants	323 Participants	302 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 56 · Slight preference for the study drug	70 Participants	75 Participants	89 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 56 · No preference either way	61 Participants	65 Participants	71 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 56 · Slight preference for my previous treatment	16 Participants	16 Participants	13 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Week 56 · No, definitely prefer my previous treatment	9 Participants	8 Participants	14 Participants

SECONDARY outcome

Timeframe: Weeks 16 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, "Number analyzed" = participants who were evaluable at specified time point for each arm, respectively.

The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess participant willingness to use drug again, participants responded using IRT on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Number of participants who responded for the specified question were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 56 · I am not sure	54 Participants	46 Participants	58 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 16 · Yes, definitely want to use the same drug again	627 Participants	641 Participants	560 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 16 · Might want to use the same drug again	138 Participants	154 Participants	169 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 16 · I am not sure	108 Participants	96 Participants	134 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 16 · Might not want to use the same drug again	19 Participants	21 Participants	23 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 16 · No:definitely wouldn't want to use same drug again	47 Participants	42 Participants	50 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 56 · Yes, definitely want to use the same drug again	352 Participants	341 Participants	310 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 56 · Might want to use the same drug again	78 Participants	75 Participants	97 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 56 · Might not want to use the same drug again	4 Participants	11 Participants	12 Participants
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Week 56 · No:definitely wouldn't want to use same drug again	10 Participants	14 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

Number of participants who withdrew from treatment due to lack of efficacy have been reported here.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants Who Withdrew Due to Lack of Efficacy	60 Participants	63 Participants	91 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'Overall number of participants analyzed' signifies participants who discontinued from the study due to lack of efficacy.

Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=60 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=63 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=91 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Time to Discontinuation Due to Lack of Efficacy	NA days Interval 7.0 to Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy, median and upper limit could not be calculated.	NA days Interval 14.0 to Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy, median and upper limit could not be calculated.	NA days Interval 14.0 to Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy, median and upper limit could not be calculated.

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 2	567 Participants	548 Participants	527 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 4	481 Participants	437 Participants	469 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 8	433 Participants	377 Participants	418 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 16	353 Participants	330 Participants	352 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 24	372 Participants	358 Participants	384 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 32	391 Participants	380 Participants	390 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 40	391 Participants	388 Participants	388 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 48	391 Participants	393 Participants	389 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 56	391 Participants	408 Participants	397 Participants

SECONDARY outcome

Timeframe: Week 64

In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during Week 64 were summarized.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=437 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=417 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=437 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants Who Took Rescue Medication During Week 64	251 Participants	268 Participants	215 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 2	2.31 days Standard Error 0.13	2.29 days Standard Error 0.13	2.26 days Standard Error 0.13
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 4	1.80 days Standard Error 0.12	1.70 days Standard Error 0.11	1.86 days Standard Error 0.12
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 8	1.65 days Standard Error 0.12	1.42 days Standard Error 0.11	1.65 days Standard Error 0.12
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 16	1.29 days Standard Error 0.11	1.25 days Standard Error 0.10	1.39 days Standard Error 0.11
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 24	1.56 days Standard Error 0.12	1.56 days Standard Error 0.13	1.65 days Standard Error 0.13
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 32	1.67 days Standard Error 0.13	1.66 days Standard Error 0.13	1.78 days Standard Error 0.13
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 40	1.70 days Standard Error 0.13	1.71 days Standard Error 0.13	1.76 days Standard Error 0.13
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 48	1.68 days Standard Error 0.13	1.76 days Standard Error 0.14	1.74 days Standard Error 0.13
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Week 56	1.73 days Standard Error 0.13	1.85 days Standard Error 0.14	1.74 days Standard Error 0.13

SECONDARY outcome

Timeframe: Week 64

In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 were summarized.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=437 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=417 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=437 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Days of Rescue Medication Used During Week 64	2.0 days Standard Deviation 2.38	2.3 days Standard Deviation 2.46	1.7 days Standard Deviation 2.26

SECONDARY outcome

Timeframe: Weeks 2, 4, 8 and 16

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).

In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 Week 2	2880.3 milligrams Standard Error 353.05	2898.7 milligrams Standard Error 358.72	3310.5 milligrams Standard Error 410.42
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 Week 4	2107.8 milligrams Standard Error 302.24	1946.5 milligrams Standard Error 277.29	2814.1 milligrams Standard Error 401.29
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 Week 8	1995.6 milligrams Standard Error 322.53	1628.8 milligrams Standard Error 258.90	2839.7 milligrams Standard Error 446.00
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 Week 16	1696.4 milligrams Standard Error 307.80	1581.6 milligrams Standard Error 284.12	2320.0 milligrams Standard Error 413.14

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure for each arm, respectively.

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Primary Care Physician	1.0 visits Interval 1.0 to 100.0	1.0 visits Interval 1.0 to 101.0	1.0 visits Interval 1.0 to 150.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Neurologist	1.0 visits Interval 1.0 to 120.0	1.0 visits Interval 1.0 to 90.0	1.0 visits Interval 1.0 to 10.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Rheumatologist	1.0 visits Interval 1.0 to 15.0	2.0 visits Interval 1.0 to 111.0	2.0 visits Interval 1.0 to 6.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline:Physician Assistant or Nurse Practitioner	1.0 visits Interval 1.0 to 6.0	1.0 visits Interval 1.0 to 122.0	1.0 visits Interval 1.0 to 120.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Pain Specialist	1.0 visits Interval 1.0 to 100.0	2.0 visits Interval 1.0 to 111.0	1.0 visits Interval 1.0 to 23.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Orthopedist	2.0 visits Interval 1.0 to 18.0	1.0 visits Interval 1.0 to 190.0	2.0 visits Interval 1.0 to 100.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Physical Therapist	4.0 visits Interval 1.0 to 100.0	3.0 visits Interval 1.0 to 111.0	3.0 visits Interval 1.0 to 32.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Chiropractor	3.0 visits Interval 1.0 to 190.0	3.0 visits Interval 1.0 to 30.0	3.0 visits Interval 1.0 to 24.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Alternative Medicine or Therapy	2.0 visits Interval 1.0 to 24.0	2.0 visits Interval 1.0 to 111.0	2.0 visits Interval 1.0 to 80.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Podiatrist	1.0 visits Interval 1.0 to 2.0	1.0 visits Interval 1.0 to 91.0	1.0 visits Interval 1.0 to 2.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Nutritionist/Dietitian	1.0 visits Interval 1.0 to 3.0	1.0 visits Interval 1.0 to 3.0	1.0 visits Interval 1.0 to 4.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Radiologist	1.0 visits Interval 1.0 to 100.0	1.0 visits Interval 1.0 to 111.0	1.0 visits Interval 1.0 to 5.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Home Healthcare Services	2.0 visits Interval 1.0 to 24.0	1.0 visits Interval 1.0 to 111.0	3.0 visits Interval 1.0 to 91.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline: Other Practitioner	2.0 visits Interval 1.0 to 190.0	2.0 visits Interval 1.0 to 111.0	2.0 visits Interval 1.0 to 111.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Primary Care Physician	1.0 visits Interval 1.0 to 190.0	1.0 visits Interval 1.0 to 101.0	1.0 visits Interval 1.0 to 120.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Neurologist	1.0 visits Interval 1.0 to 110.0	1.0 visits Interval 1.0 to 4.0	1.0 visits Interval 1.0 to 83.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Rheumatologist	1.0 visits Interval 1.0 to 4.0	1.0 visits Interval 1.0 to 4.0	1.0 visits Interval 1.0 to 3.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Physician Assistant Or Nurse Practitioner	1.0 visits Interval 1.0 to 10.0	1.0 visits Interval 1.0 to 100.0	2.0 visits Interval 1.0 to 101.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Pain Specialist	1.0 visits Interval 1.0 to 190.0	1.0 visits Interval 1.0 to 144.0	1.0 visits Interval 1.0 to 180.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Orthopedist	1.0 visits Interval 1.0 to 190.0	1.0 visits Interval 1.0 to 30.0	1.0 visits Interval 1.0 to 100.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Physical Therapist	4.0 visits Interval 1.0 to 180.0	4.5 visits Interval 1.0 to 111.0	3.0 visits Interval 1.0 to 100.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Chiropractor	3.0 visits Interval 1.0 to 21.0	2.0 visits Interval 1.0 to 30.0	3.0 visits Interval 1.0 to 111.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Alternative Medicine or Therapy	1.0 visits Interval 1.0 to 11.0	2.0 visits Interval 1.0 to 10.0	2.0 visits Interval 1.0 to 190.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Podiatrist	1.0 visits Interval 1.0 to 5.0	1.0 visits Interval 1.0 to 3.0	1.0 visits Interval 1.0 to 2.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Nutritionist/Dietitian	2.0 visits Interval 1.0 to 8.0	1.0 visits Interval 1.0 to 3.0	1.0 visits Interval 1.0 to 3.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Radiologist	1.0 visits Interval 1.0 to 100.0	1.0 visits Interval 1.0 to 30.0	1.0 visits Interval 1.0 to 100.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Home Healthcare Services	4.0 visits Interval 1.0 to 9.0	4.0 visits Interval 1.0 to 16.0	5.0 visits Interval 2.0 to 90.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 64: Other Practitioner	1.0 visits Interval 1.0 to 190.0	1.0 visits Interval 1.0 to 190.0	1.0 visits Interval 1.0 to 111.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Primary Care Physician	1.0 visits Interval 1.0 to 102.0	1.0 visits Interval 1.0 to 111.0	1.0 visits Interval 1.0 to 101.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Neurologist	1.0 visits Interval 1.0 to 1.0	1.0 visits Interval 1.0 to 6.0	1.0 visits Interval 1.0 to 2.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Rheumatologist	1.0 visits Interval 1.0 to 100.0	1.0 visits Interval 1.0 to 111.0	1.0 visits Interval 1.0 to 101.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Physician Assistant or Nurse Practitioner	1.0 visits Interval 1.0 to 6.0	1.0 visits Interval 1.0 to 4.0	1.0 visits Interval 1.0 to 90.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Pain Specialist	1.5 visits Interval 1.0 to 4.0	2.0 visits Interval 1.0 to 111.0	1.0 visits Interval 1.0 to 190.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Orthopedist	1.5 visits Interval 1.0 to 101.0	1.0 visits Interval 1.0 to 101.0	1.0 visits Interval 1.0 to 100.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Physical Therapist	8.0 visits Interval 1.0 to 30.0	5.5 visits Interval 1.0 to 21.0	3.0 visits Interval 1.0 to 21.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Chiropractor	3.0 visits Interval 1.0 to 111.0	4.5 visits Interval 1.0 to 61.0	3.0 visits Interval 1.0 to 120.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Alternative Medicine or Therapy	3.5 visits Interval 1.0 to 90.0	1.0 visits Interval 1.0 to 90.0	2.0 visits Interval 1.0 to 90.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Podiatrist	1.0 visits Interval 1.0 to 90.0	1.0 visits Interval 1.0 to 111.0	3.0 visits Interval 1.0 to 101.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Nutritionist/Dietitian	1.0 visits Interval 1.0 to 100.0	1.5 visits Interval 1.0 to 2.0	1.0 visits Interval 1.0 to 2.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Radiologist	1.0 visits Interval 1.0 to 100.0	1.0 visits Interval 1.0 to 4.0	1.0 visits Interval 1.0 to 101.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Home Healthcare Services	2.5 visits Interval 1.0 to 140.0	4.0 visits Interval 1.0 to 18.0	1.0 visits Interval 1.0 to 1.0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Week 80: Other Practitioner	1.0 visits Interval 1.0 to 190.0	1.0 visits Interval 1.0 to 100.0	1.0 visits Interval 1.0 to 100.0

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis Baseline	15 Participants	23 Participants	11 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis Week 64	10 Participants	15 Participants	5 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis Week 80	4 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=15 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=23 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=11 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis Baseline	1.0 visits Interval 1.0 to 3.0	1.0 visits Interval 1.0 to 222.0	1.0 visits Interval 1.0 to 6.0
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis Week 64	1.0 visits Interval 1.0 to 2.0	1.0 visits Interval 1.0 to 3.0	1.0 visits Interval 1.0 to 2.0
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis Week 80	1.0 visits Interval 1.0 to 2.0	3.0 visits Interval 1.0 to 11.0	1.0 visits Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis Week 80	8 Participants	12 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis Baseline	11 Participants	6 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis Week 64	5 Participants	11 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=11 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=12 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=6 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis Baseline	12.0 nights Interval 1.0 to 15.0	9.0 nights Interval 1.0 to 14.0	11.0 nights Interval 11.0 to 11.0
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis Week 64	2.0 nights Interval 1.0 to 20.0	2.0 nights Interval 1.0 to 40.0	2.0 nights Interval 1.0 to 4.0
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis Week 80	2.0 nights Interval 1.0 to 26.0	2.0 nights Interval 1.0 to 21.0	—

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Walking Aid Use · Never	852 Participants	838 Participants	851 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Walking Aid Use · Rarely	27 Participants	18 Participants	24 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Walking Aid Use · Sometimes	71 Participants	69 Participants	75 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Walking Aid Use · Often	32 Participants	43 Participants	26 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Walking Aid Use · Always	19 Participants	29 Participants	19 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Wheelchair Use · Never	992 Participants	989 Participants	988 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Wheelchair Use · Rarely	2 Participants	2 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Wheelchair Use · Sometimes	4 Participants	6 Participants	5 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Wheelchair Use · Often	3 Participants	0 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Wheelchair Use · Always	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Device/Utensil to Dress Bathe Eat · Never	970 Participants	976 Participants	977 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Device/Utensil to Dress Bathe Eat · Rarely	2 Participants	1 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Device/Utensil to Dress Bathe Eat · Sometimes	7 Participants	6 Participants	6 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Device/Utensil to Dress Bathe Eat · Often	16 Participants	9 Participants	7 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Device/Utensil to Dress Bathe Eat · Always	6 Participants	5 Participants	5 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Other Aids Or Devices · Never	932 Participants	935 Participants	921 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Other Aids Or Devices · Rarely	8 Participants	7 Participants	9 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Other Aids Or Devices · Sometimes	27 Participants	22 Participants	41 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Other Aids Or Devices · Often	27 Participants	22 Participants	14 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline: Other Aids Or Devices · Always	7 Participants	11 Participants	10 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Walking Aid Use · Never	662 Participants	662 Participants	714 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Walking Aid Use · Rarely	21 Participants	9 Participants	12 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Walking Aid Use · Sometimes	48 Participants	47 Participants	37 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Walking Aid Use · Often	20 Participants	30 Participants	17 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Walking Aid Use · Always	22 Participants	34 Participants	19 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Wheelchair Use · Never	765 Participants	776 Participants	794 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Wheelchair Use · Rarely	2 Participants	1 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Wheelchair Use · Sometimes	4 Participants	2 Participants	3 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Wheelchair Use · Often	2 Participants	1 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Wheelchair Use · Always	0 Participants	2 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Device/Utensil to Dress Bathe Eat · Never	760 Participants	768 Participants	792 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Device/Utensil to Dress Bathe Eat · Rarely	2 Participants	1 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Device/Utensil to Dress Bathe Eat · Sometimes	7 Participants	7 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Device/Utensil to Dress Bathe Eat · Often	3 Participants	5 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Device/Utensil to Dress Bathe Eat · Always	1 Participants	1 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Other Aids Or Devices · Never	733 Participants	720 Participants	771 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Other Aids Or Devices · Rarely	6 Participants	9 Participants	11 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Other Aids Or Devices · Sometimes	19 Participants	26 Participants	8 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Other Aids Or Devices · Often	12 Participants	20 Participants	6 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 64: Other Aids Or Devices · Always	3 Participants	7 Participants	3 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Walking Aid Use · Never	373 Participants	322 Participants	386 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Walking Aid Use · Rarely	12 Participants	10 Participants	6 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Walking Aid Use · Sometimes	25 Participants	25 Participants	17 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Walking Aid Use · Often	14 Participants	17 Participants	7 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Walking Aid Use · Always	8 Participants	22 Participants	8 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Wheelchair Use · Never	430 Participants	389 Participants	421 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Wheelchair Use · Rarely	0 Participants	2 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Wheelchair Use · Sometimes	1 Participants	4 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Wheelchair Use · Often	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Wheelchair Use · Always	1 Participants	1 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Device/Utensil to Dress Bathe Eat · Never	425 Participants	383 Participants	422 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Device/Utensil to Dress Bathe Eat · Rarely	0 Participants	0 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Device/Utensil to Dress Bathe Eat · Sometimes	2 Participants	6 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Device/Utensil to Dress Bathe Eat · Often	3 Participants	5 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Device/Utensil to Dress Bathe Eat · Always	2 Participants	2 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Other Aids Or Devices · Never	416 Participants	375 Participants	410 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Other Aids Or Devices · Rarely	4 Participants	3 Participants	4 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Other Aids Or Devices · Sometimes	5 Participants	11 Participants	4 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Other Aids Or Devices · Often	5 Participants	4 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Week 80: Other Aids Or Devices · Always	2 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=995 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis Baseline	47 Participants	55 Participants	65 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis Week 64	28 Participants	35 Participants	26 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis Week 80	12 Participants	18 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population was analyzed. One additional participant apart from the ones who had responded for quitting job responded to duration since quitting job. Here 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, "Number analyzed" =participants evaluable at specified time point for each arm, respectively.

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=47 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=55 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=66 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis Baseline	2.0 years Interval 0.1 to 15.4	1.8 years Interval 0.3 to 20.0	2.4 years Interval 0.1 to 80.0
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis Week 64	2.4 years Interval 0.2 to 18.6	1.8 years Interval 0.1 to 31.0	4.0 years Interval 0.1 to 90.0
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis Week 80	2.0 years Interval 0.3 to 30.4	2.0 years Interval 0.1 to 50.0	1.8 years Interval 0.2 to 20.4

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 16, 24, 56 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change \>0), No change and worsening (Change less than \[\<\] 0).

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1000 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=995 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=994 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 4 · Improvement	423 Participants	421 Participants	411 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 4 · No Change	370 Participants	394 Participants	369 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 4 · Worsening	207 Participants	180 Participants	214 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 8 · Improvement	454 Participants	443 Participants	445 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 8 · No Change	325 Participants	362 Participants	348 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 8 · Worsening	221 Participants	190 Participants	201 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 16 · Improvement	488 Participants	470 Participants	477 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 16 · No Change	288 Participants	312 Participants	312 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 16 · Worsening	224 Participants	213 Participants	205 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 24 · Improvement	478 Participants	458 Participants	467 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 24 · No Change	277 Participants	302 Participants	291 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 24 · Worsening	245 Participants	235 Participants	236 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 56 · Improvement	486 Participants	429 Participants	461 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 56 · No Change	270 Participants	314 Participants	300 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 56 · Worsening	244 Participants	252 Participants	233 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 80 · Improvement	220 Participants	196 Participants	227 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 80 · No Change	105 Participants	97 Participants	125 Participants
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Change at Week 80 · Worsening	113 Participants	115 Participants	80 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 56

Population: Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=36 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=46 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=44 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 Baseline	97.0 minutes Interval 22.6 to 164.9	107.1 minutes Interval 50.5 to 195.5	99.2 minutes Interval 13.9 to 176.9
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 Change at Week 16	3.9 minutes Interval -39.5 to 60.1	2.9 minutes Interval -49.4 to 45.1	-4.2 minutes Interval -45.5 to 67.8
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 Change at Week 56	-8.9 minutes Interval -63.5 to 16.9	-10.1 minutes Interval -25.4 to 30.2	3.9 minutes Interval -17.7 to 15.3

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 56

An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=36 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=46 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=44 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 Baseline	75244 physical activity counts Interval 12385.0 to 129724.0	95911 physical activity counts Interval 25816.0 to 428586.0	74414 physical activity counts Interval 8136.6 to 253672.0
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 Change at Week 16	-470.0 physical activity counts Interval -32693.0 to 225384.0	-2261 physical activity counts Interval -114000.0 to 125895.0	1202.9 physical activity counts Interval -70004.0 to 300461.0
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 Change at Week 56	-14552 physical activity counts Interval -42956.0 to 24607.0	-8313 physical activity counts Interval -60556.0 to 53888.0	4414.3 physical activity counts Interval -15896.0 to 56451.0

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 56

An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {\<1500} counts moderate (1,500 - \<6500 counts), and vigorous (\>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=36 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=46 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=44 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 Baseline	41.2 minutes Interval 2.2 to 80.4	53.1 minutes Interval 7.3 to 156.0	41.9 minutes Interval 0.7 to 117.0
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 Change at Week 16	0.7 minutes Interval -25.3 to 62.7	-1.6 minutes Interval -72.2 to 78.8	-0.1 minutes Interval -39.2 to 68.7
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 Change at Week 56	-3.8 minutes Interval -27.5 to 23.5	2.7 minutes Interval -27.5 to 38.5	7.4 minutes Interval -13.4 to 40.7

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 56

An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - \<1,500 counts) moderate (1,500 - \<6,500 counts), and vigorous (\>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A "bout" of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=36 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=46 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=44 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 Baseline	0.0 minutes Interval 0.0 to 16.5	0.0 minutes Interval 0.0 to 111.5	0.0 minutes Interval 0.0 to 42.4
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 Change at Week 16	0.0 minutes Interval -13.1 to 25.9	0.0 minutes Interval -73.3 to 13.0	0.0 minutes Interval -12.6 to 64.8
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 Change at Week 56	0.0 minutes Interval -5.8 to 0.0	-1.4 minutes Interval -11.5 to 8.2	0.0 minutes Interval -2.0 to 6.5

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 56

Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=36 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=46 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=44 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Average Daily Step Count at Weeks 16 and 56 Baseline	4851.0 step count Interval 827.6 to 9206.5	5834.8 step count Interval 2041.0 to 17895.0	4779.0 step count Interval 1015.6 to 11759.0
Change From Baseline in Average Daily Step Count at Weeks 16 and 56 Change at Week 16	350.9 step count Interval -4970.0 to 5017.9	87.8 step count Interval -9415.0 to 5849.9	-705.7 step count Interval -3286.0 to 6270.4
Change From Baseline in Average Daily Step Count at Weeks 16 and 56 Change at Week 56	-1938 step count Interval -4055.0 to 138.3	-543.2 step count Interval -1856.0 to 3609.9	242.6 step count Interval -4411.0 to 3312.2

SECONDARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	681 Participants	744 Participants	666 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	78 Participants	110 Participants	66 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC.

Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Treatment Related AEs	190 Participants	250 Participants	179 Participants
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Treatment Related SAEs	7 Participants	20 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 80

Population: Safety population included all participants treated with tanezumab or placebo SC. Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure.

Primary Abnormality criteria: HGB, hematocrit, RBC count \<0.8\* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width \<0.9\*LLN, \>1.1\*upper limit of normal(ULN); platelets \<0.5\*LLN,\>1.75\*ULN; Leukocytes \<0.6\*LLN, \>1.5\*ULN; Lymphocytes, Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils,Eosinophils,Monocytes\>1.2\*ULN; Prothrombin time/Intl. normalized ratio\>1.1\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides \>1.3\*ULN; Urate\>1.2\*ULN; sodium\<0.95\*LLN,\>1.05\*ULN; potassium,chloride,calcium,magnesium,bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate\<0.8\*LLN, \>1.2\*ULN; glucose\<0.6\*LLN, \>1.5\*ULN; HGB A1C \>1.3\*ULN; creatine kinase\>2.0\*ULN, specific gravity\<1.003, \>1.030; pH\<4.5, \>8;Urine erythrocytes,Leukocytes\>=20.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=877 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=897 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=884 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline	109 Participants	102 Participants	121 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 80

Primary Abnormality criteria: hemoglobin; hematocrit; RBC count \< 0.8\*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*ULN; platelets \<0.5\*LLN,\>1.75\*upper limit of normal (ULN); white blood cell count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes \<0.8\*LLN, \>1.2\*ULN; Basophils, Eosinophils, Monocytes \>1.2\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides \>1.3\*ULN; Urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN; specific gravity\<1.003, \>1.030; Urine erythrocytes,Leukocytes\>=20; Hyaline Casts\>=1.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=706 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=731 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=691 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline	78 Participants	61 Participants	84 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

Population: Safety population included all participants treated with tanezumab or placebo SC. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure for specified categories.

Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

Population: Safety population included all participants treated with tanezumab or placebo SC. Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

Heart rate (pulse rate) was measured at sitting position.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 56	0.2 beats per minute Standard Deviation 9.51	0.1 beats per minute Standard Deviation 10.15	-0.0 beats per minute Standard Deviation 9.28
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 64	1.5 beats per minute Standard Deviation 9.81	1.5 beats per minute Standard Deviation 9.55	0.5 beats per minute Standard Deviation 9.84
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Baseline	70.8 beats per minute Standard Deviation 9.09	70.5 beats per minute Standard Deviation 9.66	70.6 beats per minute Standard Deviation 9.36
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 2	1.8 beats per minute Standard Deviation 8.65	2.0 beats per minute Standard Deviation 8.50	1.1 beats per minute Standard Deviation 8.31
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 4	1.6 beats per minute Standard Deviation 9.00	2.0 beats per minute Standard Deviation 9.03	1.2 beats per minute Standard Deviation 8.75
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 8	0.7 beats per minute Standard Deviation 9.06	0.8 beats per minute Standard Deviation 8.54	0.1 beats per minute Standard Deviation 8.78
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 16	0.5 beats per minute Standard Deviation 9.37	0.5 beats per minute Standard Deviation 9.14	0.8 beats per minute Standard Deviation 8.86
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 24	0.4 beats per minute Standard Deviation 9.46	0.7 beats per minute Standard Deviation 9.36	0.8 beats per minute Standard Deviation 9.24
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 32	1.2 beats per minute Standard Deviation 9.67	1.6 beats per minute Standard Deviation 9.34	1.7 beats per minute Standard Deviation 9.70
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 40	1.2 beats per minute Standard Deviation 9.89	1.6 beats per minute Standard Deviation 9.40	1.4 beats per minute Standard Deviation 8.71
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 48	0.6 beats per minute Standard Deviation 9.86	1.0 beats per minute Standard Deviation 9.34	1.3 beats per minute Standard Deviation 9.44
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 80	0.9 beats per minute Standard Deviation 10.24	0.6 beats per minute Standard Deviation 9.97	0.9 beats per minute Standard Deviation 9.61

SECONDARY outcome

Timeframe: Baseline, Weeks 56 and 80

Population: Safety population included all participants treated with tanezumab or placebo SC. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, "Number analyzed" =participants who were evaluable at specified time point for each arm, respectively.

A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (\>) 30 millisecond (ms) or 60 ms; absolute value \> 450 ms, \>480 ms and \> 500 ms; 2) heart rate (HR) : absolute value \<=50 bpm and decrease from baseline \>=20 bpm; absolute value \>=120 beats per minute (bpm) and increase from baseline \>=20 bpm; 3) PR interval: absolute value \>=220 ms and increase from baseline \>=20 ms; 4) QRS interval: absolute value \>= 120 ms.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=995 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=995 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QTCB Interval: Baseline	419.3 milliseconds Standard Deviation 21.85	418.5 milliseconds Standard Deviation 21.96	419.7 milliseconds Standard Deviation 21.60
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QTCB Interval:Change at Week 56	2.3 milliseconds Standard Deviation 18.82	0.5 milliseconds Standard Deviation 17.83	0.2 milliseconds Standard Deviation 19.66
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QTCB Interval:Change at Week 80	1.5 milliseconds Standard Deviation 19.37	0.2 milliseconds Standard Deviation 17.98	1.7 milliseconds Standard Deviation 19.06
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QTCF Interval: Baseline	414.2 milliseconds Standard Deviation 19.96	413.3 milliseconds Standard Deviation 20.09	414.3 milliseconds Standard Deviation 19.49
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 RR Interval: Baseline	940.5 milliseconds Standard Deviation 136.21	940.1 milliseconds Standard Deviation 144.48	936.1 milliseconds Standard Deviation 142.31
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 RR Interval:Change at Week 56	-26.3 milliseconds Standard Deviation 123.23	-22.6 milliseconds Standard Deviation 128.58	-14.9 milliseconds Standard Deviation 128.73
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 RR Interval:Change at Week 80	-33.6 milliseconds Standard Deviation 119.23	-32.4 milliseconds Standard Deviation 126.08	-34.3 milliseconds Standard Deviation 133.83
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 PR Interval: Baseline	165.0 milliseconds Standard Deviation 27.43	165.9 milliseconds Standard Deviation 25.45	163.9 milliseconds Standard Deviation 23.98
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 PR Interval:Change at Week 56	1.7 milliseconds Standard Deviation 12.98	0.6 milliseconds Standard Deviation 13.33	1.7 milliseconds Standard Deviation 14.40
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 PR Interval:Change at Week 80	0.3 milliseconds Standard Deviation 13.39	-0.8 milliseconds Standard Deviation 14.70	0.6 milliseconds Standard Deviation 13.80
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QRS Interval: Baseline	94.9 milliseconds Standard Deviation 13.12	94.6 milliseconds Standard Deviation 13.65	94.3 milliseconds Standard Deviation 13.16
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QRS Interval:Change at Week 56	0.2 milliseconds Standard Deviation 8.22	0.4 milliseconds Standard Deviation 8.30	-0.4 milliseconds Standard Deviation 7.39
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QRS Interval:Change at Week 80	-0.2 milliseconds Standard Deviation 8.12	1.0 milliseconds Standard Deviation 8.64	-0.1 milliseconds Standard Deviation 7.81
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QT Interval: Baseline	405.0 milliseconds Standard Deviation 28.86	403.8 milliseconds Standard Deviation 30.08	404.3 milliseconds Standard Deviation 29.33
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QT Interval:Change at Week 56	-3.5 milliseconds Standard Deviation 24.07	-4.5 milliseconds Standard Deviation 25.06	-2.9 milliseconds Standard Deviation 26.58
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QT Interval:Change at Week 80	-6.2 milliseconds Standard Deviation 22.56	-6.8 milliseconds Standard Deviation 24.46	-6.0 milliseconds Standard Deviation 25.34
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QTCF Interval:Change at Week 56	0.3 milliseconds Standard Deviation 16.24	-1.2 milliseconds Standard Deviation 15.55	-0.8 milliseconds Standard Deviation 17.50
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 QTCF Interval:Change at Week 80	-1.2 milliseconds Standard Deviation 16.16	-2.1 milliseconds Standard Deviation 15.55	-1.0 milliseconds Standard Deviation 16.21

SECONDARY outcome

Timeframe: Baseline, Weeks 56 and 80

Heart rate was measured at sitting position.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=995 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=995 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 Baseline	65.2 beats per minute Standard Deviation 9.70	65.4 beats per minute Standard Deviation 10.30	65.6 beats per minute Standard Deviation 10.36
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 Change at Week 56	2.0 beats per minute Standard Deviation 9.10	1.7 beats per minute Standard Deviation 9.72	1.0 beats per minute Standard Deviation 9.95
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 Change at Week 80	2.7 beats per minute Standard Deviation 9.00	2.3 beats per minute Standard Deviation 9.34	2.5 beats per minute Standard Deviation 10.02

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP \<=150 mmHg (mean supine): Reduction in systolic BP\>=20 mmHg or reduction in diastolic BP\>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP \>150 mmHg (mean supine): Reduction in systolic BP\>=30 mmHg or reduction in diastolic BP\>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1001 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=996 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Confirmed Orthostatic Hypotension Baseline	0 Participants	3 Participants	1 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 2	2 Participants	4 Participants	2 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 4	1 Participants	1 Participants	2 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 8	0 Participants	2 Participants	1 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 16	1 Participants	1 Participants	0 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 24	0 Participants	1 Participants	1 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 32	2 Participants	2 Participants	0 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 40	1 Participants	1 Participants	1 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 48	2 Participants	2 Participants	0 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 56	1 Participants	1 Participants	1 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 64	0 Participants	1 Participants	3 Participants
Number of Participants With Confirmed Orthostatic Hypotension Week 80	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 56 and 80

The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1000 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=997 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Number of symptoms reported: Change at Week 24	0.21 units on a scale Standard Deviation 1.13	0.18 units on a scale Standard Deviation 1.22	0.11 units on a scale Standard Deviation 1.20
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Number of symptoms reported: Change at Week 56	0.28 units on a scale Standard Deviation 1.19	0.33 units on a scale Standard Deviation 1.34	0.22 units on a scale Standard Deviation 1.21
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Number of symptoms reported: Change at Week 80	0.89 units on a scale Standard Deviation 1.39	0.94 units on a scale Standard Deviation 1.43	0.74 units on a scale Standard Deviation 1.22
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Total symptom impact score: Baseline	1.10 units on a scale Standard Deviation 1.84	1.23 units on a scale Standard Deviation 1.89	1.13 units on a scale Standard Deviation 1.82
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Total symptom impact score: Change at Week 24	0.66 units on a scale Standard Deviation 2.90	0.52 units on a scale Standard Deviation 3.19	0.33 units on a scale Standard Deviation 2.99
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Total symptom impact score: Change at Week 56	0.97 units on a scale Standard Deviation 3.29	1.21 units on a scale Standard Deviation 4.01	0.82 units on a scale Standard Deviation 3.40
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Number of symptoms reported: Baseline	0.47 units on a scale Standard Deviation 0.76	0.53 units on a scale Standard Deviation 0.78	0.49 units on a scale Standard Deviation 0.76
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Total symptom impact score: Change at Week 80	1.33 units on a scale Standard Deviation 3.85	1.31 units on a scale Standard Deviation 4.36	0.89 units on a scale Standard Deviation 3.65

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1000 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=995 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=994 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 24	-0.32 units on a scale Standard Deviation 2.39	-0.35 units on a scale Standard Deviation 2.76	-0.49 units on a scale Standard Deviation 3.08
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 32	-0.37 units on a scale Standard Deviation 2.46	-0.40 units on a scale Standard Deviation 2.75	-0.53 units on a scale Standard Deviation 3.17
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 40	-0.35 units on a scale Standard Deviation 2.42	-0.43 units on a scale Standard Deviation 2.80	-0.53 units on a scale Standard Deviation 3.32
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 48	-0.37 units on a scale Standard Deviation 2.46	-0.49 units on a scale Standard Deviation 3.13	-0.55 units on a scale Standard Deviation 3.21
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 56	-0.35 units on a scale Standard Deviation 2.48	-0.52 units on a scale Standard Deviation 3.26	-0.58 units on a scale Standard Deviation 3.22
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 64	-0.32 units on a scale Standard Deviation 2.60	-0.47 units on a scale Standard Deviation 3.24	-0.57 units on a scale Standard Deviation 3.20
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 80	-0.35 units on a scale Standard Deviation 2.53	-0.47 units on a scale Standard Deviation 3.35	-0.62 units on a scale Standard Deviation 3.28
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Baseline	1.85 units on a scale Standard Deviation 4.30	1.70 units on a scale Standard Deviation 4.45	1.87 units on a scale Standard Deviation 4.47
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 2	-0.22 units on a scale Standard Deviation 2.15	-0.13 units on a scale Standard Deviation 1.40	-0.15 units on a scale Standard Deviation 1.67
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 4	-0.16 units on a scale Standard Deviation 2.06	-0.17 units on a scale Standard Deviation 1.92	-0.19 units on a scale Standard Deviation 2.32
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 8	-0.27 units on a scale Standard Deviation 2.28	-0.22 units on a scale Standard Deviation 2.08	-0.36 units on a scale Standard Deviation 2.55
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Change at Week 16	-0.27 units on a scale Standard Deviation 2.32	-0.31 units on a scale Standard Deviation 2.48	-0.47 units on a scale Standard Deviation 3.06

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80

Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Number of Participants With Anti-Tanezumab Antibodies Baseline	116 Participants	83 Participants	—
Number of Participants With Anti-Tanezumab Antibodies Week 8	120 Participants	93 Participants	—
Number of Participants With Anti-Tanezumab Antibodies Week 16	98 Participants	83 Participants	—
Number of Participants With Anti-Tanezumab Antibodies Week 32	108 Participants	81 Participants	—
Number of Participants With Anti-Tanezumab Antibodies Week 48	96 Participants	78 Participants	—
Number of Participants With Anti-Tanezumab Antibodies Week 56	82 Participants	66 Participants	—
Number of Participants With Anti-Tanezumab Antibodies Week 64	69 Participants	60 Participants	—
Number of Participants With Anti-Tanezumab Antibodies Week 80	50 Participants	42 Participants	—

Adverse Events

Tanezumab 2.5 mg

Serious events: 51 serious events

Other events: 301 other events

Deaths: 4 deaths

Tanezumab 5 mg

Serious events: 80 serious events

Other events: 318 other events

Deaths: 5 deaths

NSAID

Serious events: 46 serious events

Other events: 264 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Tanezumab 2.5 mg n=1002 participants at risk Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 participants at risk Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 participants at risk Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Infections and infestations Nasopharyngitis	5.7% 57/1002 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	6.7% 67/998 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.0% 40/996 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Upper respiratory tract infection	5.7% 57/1002 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.5% 45/998 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	5.9% 59/996 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Fall	6.5% 65/1002 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	5.2% 52/998 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.6% 46/996 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Arthralgia	13.1% 131/1002 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	16.0% 160/998 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	11.7% 117/996 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Back pain	3.4% 34/1002 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	5.5% 55/998 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	3.4% 34/996 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Headache	5.6% 56/1002 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.5% 45/998 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.5% 25/996 • Baseline up to Week 56 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Tanezumab 2.5 mg n=1002 Participants Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.	Tanezumab 5 mg n=998 Participants Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.	NSAID n=996 Participants Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Baseline	128.9 millimeters of mercury (mmHg) Standard Deviation 12.91	129.3 millimeters of mercury (mmHg) Standard Deviation 13.43	128.8 millimeters of mercury (mmHg) Standard Deviation 13.26
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 2	-2.7 millimeters of mercury (mmHg) Standard Deviation 11.69	-4.2 millimeters of mercury (mmHg) Standard Deviation 11.92	-1.2 millimeters of mercury (mmHg) Standard Deviation 11.24
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 4	-4.0 millimeters of mercury (mmHg) Standard Deviation 11.44	-4.9 millimeters of mercury (mmHg) Standard Deviation 12.68	-1.8 millimeters of mercury (mmHg) Standard Deviation 11.29
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 8	-2.9 millimeters of mercury (mmHg) Standard Deviation 12.16	-3.8 millimeters of mercury (mmHg) Standard Deviation 12.60	-1.8 millimeters of mercury (mmHg) Standard Deviation 11.68
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 16	-3.0 millimeters of mercury (mmHg) Standard Deviation 11.66	-3.7 millimeters of mercury (mmHg) Standard Deviation 12.95	-1.3 millimeters of mercury (mmHg) Standard Deviation 12.37
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 24	-3.0 millimeters of mercury (mmHg) Standard Deviation 12.35	-3.1 millimeters of mercury (mmHg) Standard Deviation 13.49	-1.7 millimeters of mercury (mmHg) Standard Deviation 11.83
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 32	-2.8 millimeters of mercury (mmHg) Standard Deviation 11.95	-3.3 millimeters of mercury (mmHg) Standard Deviation 13.70	-1.7 millimeters of mercury (mmHg) Standard Deviation 13.49
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 40	-2.5 millimeters of mercury (mmHg) Standard Deviation 11.35	-3.8 millimeters of mercury (mmHg) Standard Deviation 14.41	-2.3 millimeters of mercury (mmHg) Standard Deviation 13.42
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 48	-2.7 millimeters of mercury (mmHg) Standard Deviation 12.21	-3.0 millimeters of mercury (mmHg) Standard Deviation 13.29	-2.2 millimeters of mercury (mmHg) Standard Deviation 12.97
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 56	-3.1 millimeters of mercury (mmHg) Standard Deviation 11.76	-3.4 millimeters of mercury (mmHg) Standard Deviation 13.78	-2.2 millimeters of mercury (mmHg) Standard Deviation 12.64
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 64	-2.1 millimeters of mercury (mmHg) Standard Deviation 13.40	-2.1 millimeters of mercury (mmHg) Standard Deviation 13.56	-2.8 millimeters of mercury (mmHg) Standard Deviation 13.33
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 SBP: Change at Week 80	-1.0 millimeters of mercury (mmHg) Standard Deviation 13.24	-1.3 millimeters of mercury (mmHg) Standard Deviation 13.71	-2.3 millimeters of mercury (mmHg) Standard Deviation 13.31
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Baseline	79.3 millimeters of mercury (mmHg) Standard Deviation 8.56	79.1 millimeters of mercury (mmHg) Standard Deviation 8.68	79.3 millimeters of mercury (mmHg) Standard Deviation 8.57
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 2	-1.3 millimeters of mercury (mmHg) Standard Deviation 8.29	-2.1 millimeters of mercury (mmHg) Standard Deviation 7.96	-1.1 millimeters of mercury (mmHg) Standard Deviation 7.84
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 4	-2.2 millimeters of mercury (mmHg) Standard Deviation 8.06	-2.5 millimeters of mercury (mmHg) Standard Deviation 8.10	-1.4 millimeters of mercury (mmHg) Standard Deviation 8.19
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 8	-1.1 millimeters of mercury (mmHg) Standard Deviation 7.84	-1.7 millimeters of mercury (mmHg) Standard Deviation 8.24	-1.1 millimeters of mercury (mmHg) Standard Deviation 8.23
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 16	-1.3 millimeters of mercury (mmHg) Standard Deviation 8.14	-1.8 millimeters of mercury (mmHg) Standard Deviation 8.53	-1.1 millimeters of mercury (mmHg) Standard Deviation 8.30
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 24	-1.3 millimeters of mercury (mmHg) Standard Deviation 8.39	-1.7 millimeters of mercury (mmHg) Standard Deviation 8.91	-1.4 millimeters of mercury (mmHg) Standard Deviation 8.26
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 32	-1.3 millimeters of mercury (mmHg) Standard Deviation 8.28	-1.4 millimeters of mercury (mmHg) Standard Deviation 9.14	-1.2 millimeters of mercury (mmHg) Standard Deviation 8.91
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 40	-1.2 millimeters of mercury (mmHg) Standard Deviation 8.07	-2.0 millimeters of mercury (mmHg) Standard Deviation 8.90	-1.1 millimeters of mercury (mmHg) Standard Deviation 8.69
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 48	-0.9 millimeters of mercury (mmHg) Standard Deviation 8.82	-1.8 millimeters of mercury (mmHg) Standard Deviation 8.89	-1.5 millimeters of mercury (mmHg) Standard Deviation 8.65
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 56	-1.8 millimeters of mercury (mmHg) Standard Deviation 8.61	-1.9 millimeters of mercury (mmHg) Standard Deviation 9.11	-1.2 millimeters of mercury (mmHg) Standard Deviation 8.69
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 64	-0.8 millimeters of mercury (mmHg) Standard Deviation 8.63	-0.8 millimeters of mercury (mmHg) Standard Deviation 9.23	-1.7 millimeters of mercury (mmHg) Standard Deviation 9.03
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 DBP: Change at Week 80	-0.6 millimeters of mercury (mmHg) Standard Deviation 8.73	-0.6 millimeters of mercury (mmHg) Standard Deviation 9.66	-1.2 millimeters of mercury (mmHg) Standard Deviation 9.35