Trial Outcomes & Findings for Tanezumab In Osteoarthritis Of The Hip Or Knee (NCT NCT00985621)

Results Overview

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis (OA) in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

614 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2021-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Overall Study STARTED	142	161	152	159
Overall Study Treated	141	161	150	158
Overall Study COMPLETED	28	30	29	22
Overall Study NOT COMPLETED	114	131	123	137

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Overall Study Adverse Event	2	3	4	16
Overall Study Lack of Efficacy	10	6	5	12
Overall Study Lost to Follow-up	2	3	4	4
Overall Study Study Terminated by Sponsor	89	108	99	92
Overall Study Protocol Violation	1	1	1	0
Overall Study Withdrawal by Subject	8	10	8	12
Overall Study Other	1	0	0	0
Overall Study Randomized but not Treated	1	0	2	1

Baseline Characteristics

Tanezumab In Osteoarthritis Of The Hip Or Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.	Total n=610 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 10.5 • n=5 Participants	57.8 years STANDARD_DEVIATION 9.2 • n=7 Participants	57.0 years STANDARD_DEVIATION 9.8 • n=5 Participants	57.6 years STANDARD_DEVIATION 9.1 • n=4 Participants	57.4 years STANDARD_DEVIATION 9.6 • n=21 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	96 Participants n=7 Participants	94 Participants n=5 Participants	99 Participants n=4 Participants	381 Participants n=21 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	65 Participants n=7 Participants	56 Participants n=5 Participants	59 Participants n=4 Participants	229 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using last observation carried forward (LOCF).

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis (OA) in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population Baseline	7.75 units on a scale Standard Deviation 1.21	7.85 units on a scale Standard Deviation 1.27	7.63 units on a scale Standard Deviation 1.30	7.85 units on a scale Standard Deviation 1.27
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population Change at Week 8	-2.74 units on a scale Standard Deviation 2.26	-3.71 units on a scale Standard Deviation 2.49	-3.63 units on a scale Standard Deviation 2.62	-2.71 units on a scale Standard Deviation 2.36

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: Modified intent-to-treat (mITT) analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the United States Food and Drug Administration \[US FDA\] imposed clinical hold). Missing data were imputed using LOCF.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population Baseline	7.75 units on a scale Standard Deviation 1.20	7.87 units on a scale Standard Deviation 1.26	7.64 units on a scale Standard Deviation 1.31	7.86 units on a scale Standard Deviation 1.27
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population Change at Week 8	-2.58 units on a scale Standard Deviation 2.30	-3.42 units on a scale Standard Deviation 2.64	-3.01 units on a scale Standard Deviation 2.69	-2.41 units on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population Change at Week 2	-2.12 units on a scale Standard Deviation 1.91	-2.47 units on a scale Standard Deviation 2.23	-2.29 units on a scale Standard Deviation 2.25	-2.31 units on a scale Standard Deviation 2.09
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population Change at Week 4	-2.55 units on a scale Standard Deviation 2.09	-3.56 units on a scale Standard Deviation 2.54	-3.45 units on a scale Standard Deviation 2.62	-2.87 units on a scale Standard Deviation 2.25
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population Change at Week 12	-2.85 units on a scale Standard Deviation 2.37	-3.82 units on a scale Standard Deviation 2.62	-3.64 units on a scale Standard Deviation 2.60	-2.80 units on a scale Standard Deviation 2.41
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population Change at Week 16	-2.95 units on a scale Standard Deviation 2.46	-3.80 units on a scale Standard Deviation 2.60	-3.65 units on a scale Standard Deviation 2.51	-2.79 units on a scale Standard Deviation 2.39

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population Change at Week 16	-2.85 units on a scale Standard Deviation 2.55	-3.63 units on a scale Standard Deviation 2.77	-3.16 units on a scale Standard Deviation 2.68	-2.58 units on a scale Standard Deviation 2.35
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population Change at Week 2	-1.98 units on a scale Standard Deviation 1.92	-2.34 units on a scale Standard Deviation 2.25	-2.05 units on a scale Standard Deviation 2.18	-2.08 units on a scale Standard Deviation 2.17
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population Change at Week 4	-2.37 units on a scale Standard Deviation 2.15	-3.27 units on a scale Standard Deviation 2.58	-2.85 units on a scale Standard Deviation 2.68	-2.48 units on a scale Standard Deviation 2.29
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population Change at Week 12	-2.69 units on a scale Standard Deviation 2.42	-3.58 units on a scale Standard Deviation 2.76	-3.06 units on a scale Standard Deviation 2.69	-2.57 units on a scale Standard Deviation 2.37

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Outcome measures

Outcome measures
Measure	Placebo n=140 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 4	-1.89 units on a scale Standard Deviation 1.96	-3.04 units on a scale Standard Deviation 2.59	-2.94 units on a scale Standard Deviation 2.61	-2.10 units on a scale Standard Deviation 2.20
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Baseline	7.19 units on a scale Standard Deviation 1.50	7.30 units on a scale Standard Deviation 1.58	7.04 units on a scale Standard Deviation 1.54	7.25 units on a scale Standard Deviation 1.53
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 2	-1.51 units on a scale Standard Deviation 1.73	-2.16 units on a scale Standard Deviation 2.30	-1.95 units on a scale Standard Deviation 2.08	-1.71 units on a scale Standard Deviation 1.94
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 8	-2.01 units on a scale Standard Deviation 2.09	-3.18 units on a scale Standard Deviation 2.49	-3.08 units on a scale Standard Deviation 2.50	-2.14 units on a scale Standard Deviation 2.30
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 12	-2.17 units on a scale Standard Deviation 2.26	-3.34 units on a scale Standard Deviation 2.62	-3.09 units on a scale Standard Deviation 2.45	-2.17 units on a scale Standard Deviation 2.28
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 16	-2.26 units on a scale Standard Deviation 2.37	-3.27 units on a scale Standard Deviation 2.61	-3.10 units on a scale Standard Deviation 2.42	-2.18 units on a scale Standard Deviation 2.26

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Outcome measures

Outcome measures
Measure	Placebo n=136 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Baseline	7.17 units on a scale Standard Deviation 1.51	7.32 units on a scale Standard Deviation 1.59	7.05 units on a scale Standard Deviation 1.54	7.26 units on a scale Standard Deviation 1.53
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 2	-1.41 units on a scale Standard Deviation 1.73	-2.00 units on a scale Standard Deviation 2.32	-1.73 units on a scale Standard Deviation 1.99	-1.56 units on a scale Standard Deviation 1.94
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 4	-1.73 units on a scale Standard Deviation 2.00	-2.80 units on a scale Standard Deviation 2.69	-2.47 units on a scale Standard Deviation 2.59	-1.83 units on a scale Standard Deviation 2.16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 8	-1.87 units on a scale Standard Deviation 2.03	-3.00 units on a scale Standard Deviation 2.68	-2.62 units on a scale Standard Deviation 2.58	-1.87 units on a scale Standard Deviation 2.24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 12	-2.03 units on a scale Standard Deviation 2.21	-3.19 units on a scale Standard Deviation 2.78	-2.65 units on a scale Standard Deviation 2.60	-1.95 units on a scale Standard Deviation 2.24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 16	-2.20 units on a scale Standard Deviation 2.38	-3.22 units on a scale Standard Deviation 2.78	-2.77 units on a scale Standard Deviation 2.64	-1.97 units on a scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population Baseline	3.60 units on a scale Standard Deviation 0.68	3.58 units on a scale Standard Deviation 0.65	3.57 units on a scale Standard Deviation 0.68	3.59 units on a scale Standard Deviation 0.62
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 2	-0.49 units on a scale Standard Deviation 0.88	-0.71 units on a scale Standard Deviation 0.90	-0.63 units on a scale Standard Deviation 0.78	-0.54 units on a scale Standard Deviation 0.76
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 4	-0.57 units on a scale Standard Deviation 0.85	-0.99 units on a scale Standard Deviation 0.96	-0.99 units on a scale Standard Deviation 0.84	-0.64 units on a scale Standard Deviation 0.78
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 8	-0.56 units on a scale Standard Deviation 0.86	-0.93 units on a scale Standard Deviation 0.97	-1.01 units on a scale Standard Deviation 0.97	-0.58 units on a scale Standard Deviation 0.78
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 12	-0.64 units on a scale Standard Deviation 0.88	-0.99 units on a scale Standard Deviation 0.97	-1.07 units on a scale Standard Deviation 0.96	-0.59 units on a scale Standard Deviation 0.86
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 16	-0.63 units on a scale Standard Deviation 0.87	-0.96 units on a scale Standard Deviation 0.97	-1.07 units on a scale Standard Deviation 0.95	-0.59 units on a scale Standard Deviation 0.83

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population Baseline	3.59 units on a scale Standard Deviation 0.68	3.59 units on a scale Standard Deviation 0.65	3.56 units on a scale Standard Deviation 0.68	3.59 units on a scale Standard Deviation 0.62
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 2	-0.47 units on a scale Standard Deviation 0.88	-0.71 units on a scale Standard Deviation 0.89	-0.55 units on a scale Standard Deviation 0.76	-0.49 units on a scale Standard Deviation 0.74
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 4	-0.50 units on a scale Standard Deviation 0.86	-0.94 units on a scale Standard Deviation 0.95	-0.82 units on a scale Standard Deviation 0.82	-0.54 units on a scale Standard Deviation 0.75
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 8	-0.55 units on a scale Standard Deviation 0.91	-0.93 units on a scale Standard Deviation 0.98	-0.81 units on a scale Standard Deviation 0.84	-0.52 units on a scale Standard Deviation 0.74
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 12	-0.63 units on a scale Standard Deviation 0.93	-0.98 units on a scale Standard Deviation 0.96	-0.83 units on a scale Standard Deviation 0.84	-0.56 units on a scale Standard Deviation 0.81
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 16	-0.67 units on a scale Standard Deviation 0.94	-0.97 units on a scale Standard Deviation 0.97	-0.87 units on a scale Standard Deviation 0.83	-0.55 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

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

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population Week 2	70 Participants	89 Participants	82 Participants	81 Participants
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population Week 4	87 Participants	117 Participants	107 Participants	97 Participants
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population Week 8	81 Participants	120 Participants	105 Participants	93 Participants
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population Week 12	83 Participants	120 Participants	110 Participants	100 Participants
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population Week 16	84 Participants	120 Participants	112 Participants	95 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

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

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population Week 2	64 Participants	79 Participants	74 Participants	70 Participants
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population Week 4	76 Participants	105 Participants	87 Participants	83 Participants
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population Week 8	78 Participants	108 Participants	86 Participants	80 Participants
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population Week 12	80 Participants	110 Participants	89 Participants	87 Participants
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population Week 16	84 Participants	111 Participants	93 Participants	87 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 12: >=70% Reduction	26 Participants	48 Participants	44 Participants	26 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 12: >=90% Reduction	6 Participants	25 Participants	18 Participants	6 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 16: >=30% Reduction	78 Participants	107 Participants	103 Participants	78 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 2: >=30% Reduction	59 Participants	75 Participants	66 Participants	71 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 2: >=50% Reduction	30 Participants	46 Participants	42 Participants	33 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 2: >=70% Reduction	10 Participants	23 Participants	15 Participants	13 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 2: >=90% Reduction	1 Participants	5 Participants	4 Participants	5 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 4: >=30% Reduction	72 Participants	98 Participants	97 Participants	86 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 4: >=50% Reduction	44 Participants	72 Participants	68 Participants	48 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 4: >=70% Reduction	15 Participants	48 Participants	47 Participants	25 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 4: >=90% Reduction	3 Participants	20 Participants	14 Participants	7 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 8: >=30% Reduction	78 Participants	109 Participants	99 Participants	75 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 8: >=50% Reduction	47 Participants	71 Participants	73 Participants	47 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 8: >=70% Reduction	21 Participants	44 Participants	47 Participants	27 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 8: >=90% Reduction	5 Participants	20 Participants	16 Participants	4 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 12: >=30% Reduction	80 Participants	107 Participants	102 Participants	81 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 12: >=50% Reduction	44 Participants	75 Participants	77 Participants	51 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 16: >=50% Reduction	47 Participants	76 Participants	75 Participants	51 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 16: >=70% Reduction	29 Participants	47 Participants	43 Participants	28 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Week 16: >=90% Reduction	8 Participants	24 Participants	19 Participants	3 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 8: >=70% Reduction	16 Participants	43 Participants	39 Participants	22 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 16: >=70% Reduction	25 Participants	47 Participants	40 Participants	21 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 16: >=90% Reduction	8 Participants	23 Participants	10 Participants	5 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 2: >=30% Reduction	54 Participants	67 Participants	58 Participants	63 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 2: >=50% Reduction	28 Participants	41 Participants	37 Participants	31 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 2: >=70% Reduction	9 Participants	21 Participants	12 Participants	13 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 2: >=90% Reduction	1 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 4: >=30% Reduction	62 Participants	88 Participants	78 Participants	74 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 4: >=50% Reduction	39 Participants	61 Participants	55 Participants	40 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 4: >=70% Reduction	13 Participants	40 Participants	37 Participants	22 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 4: >=90% Reduction	3 Participants	17 Participants	9 Participants	6 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 8: >=30% Reduction	73 Participants	94 Participants	81 Participants	69 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 8: >=50% Reduction	43 Participants	63 Participants	57 Participants	38 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 8: >=90% Reduction	5 Participants	19 Participants	8 Participants	4 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 12: >=30% Reduction	76 Participants	97 Participants	83 Participants	76 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 12: >=50% Reduction	41 Participants	68 Participants	61 Participants	43 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 12: >=70% Reduction	21 Participants	45 Participants	38 Participants	21 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 12: >=90% Reduction	6 Participants	24 Participants	9 Participants	7 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 16: >=30% Reduction	78 Participants	97 Participants	87 Participants	75 Participants
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population Week 16: >=50% Reduction	44 Participants	71 Participants	63 Participants	44 Participants

SECONDARY outcome

Timeframe: Week 8

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 8 are reported.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population Greater than (>) 0% Reduction	121 Participants	149 Participants	134 Participants	139 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population >=40% Reduction	54 Participants	93 Participants	86 Participants	57 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population >=10% Reduction	109 Participants	138 Participants	127 Participants	125 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population >=20% Reduction	91 Participants	125 Participants	110 Participants	101 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population >=30% Reduction	78 Participants	109 Participants	99 Participants	75 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population >=50% Reduction	47 Participants	71 Participants	73 Participants	47 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population >=60% Reduction	31 Participants	62 Participants	61 Participants	38 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population >=70% Reduction	21 Participants	44 Participants	47 Participants	27 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population >=80% Reduction	11 Participants	30 Participants	28 Participants	10 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population >=90% Reduction	5 Participants	20 Participants	16 Participants	4 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population 100% Reduction	0 Participants	12 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 8

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >0% Reduction	108 Participants	127 Participants	115 Participants	119 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >=10% Reduction	94 Participants	119 Participants	111 Participants	105 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >=20% Reduction	83 Participants	106 Participants	92 Participants	92 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >=30% Reduction	73 Participants	94 Participants	81 Participants	69 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >=40% Reduction	51 Participants	80 Participants	67 Participants	51 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >=50% Reduction	43 Participants	63 Participants	57 Participants	38 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >=60% Reduction	29 Participants	54 Participants	47 Participants	31 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >=70% Reduction	16 Participants	43 Participants	39 Participants	22 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >=80% Reduction	14 Participants	26 Participants	22 Participants	11 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population >=90% Reduction	5 Participants	19 Participants	8 Participants	4 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population 100% Reduction	1 Participants	11 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population Week 2	16 Participants	24 Participants	19 Participants	17 Participants
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population Week 4	17 Participants	45 Participants	37 Participants	19 Participants
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population Week 8	13 Participants	36 Participants	42 Participants	17 Participants
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population Week 12	17 Participants	40 Participants	47 Participants	23 Participants
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population Week 16	18 Participants	38 Participants	44 Participants	18 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population Week 2	15 Participants	23 Participants	17 Participants	16 Participants
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population Week 4	16 Participants	39 Participants	32 Participants	15 Participants
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population Week 8	14 Participants	38 Participants	31 Participants	14 Participants
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population Week 12	18 Participants	39 Participants	33 Participants	19 Participants
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population Week 16	21 Participants	39 Participants	35 Participants	16 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.

Outcome measures

Outcome measures
Measure	Placebo n=138 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=160 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=148 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=155 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Baseline	7.18 units on a scale Standard Deviation 1.80	7.28 units on a scale Standard Deviation 1.62	6.98 units on a scale Standard Deviation 1.84	7.03 units on a scale Standard Deviation 1.72
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Change at Week 1	-0.79 units on a scale Standard Deviation 1.30	-1.71 units on a scale Standard Deviation 1.93	-1.47 units on a scale Standard Deviation 1.84	-1.15 units on a scale Standard Deviation 1.65
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Change at Week 3	-1.57 units on a scale Standard Deviation 1.73	-2.27 units on a scale Standard Deviation 2.42	-1.71 units on a scale Standard Deviation 2.29	-1.67 units on a scale Standard Deviation 2.08
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Change at Week 2	-1.26 units on a scale Standard Deviation 1.63	-1.96 units on a scale Standard Deviation 2.23	-1.43 units on a scale Standard Deviation 2.13	-1.54 units on a scale Standard Deviation 1.99
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Change at Week 4	-1.70 units on a scale Standard Deviation 1.81	-2.65 units on a scale Standard Deviation 2.49	-2.28 units on a scale Standard Deviation 2.60	-1.76 units on a scale Standard Deviation 2.10
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Change at Week 6	-1.91 units on a scale Standard Deviation 1.95	-2.87 units on a scale Standard Deviation 2.55	-2.43 units on a scale Standard Deviation 2.66	-1.94 units on a scale Standard Deviation 2.18
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Change at Week 8	-1.96 units on a scale Standard Deviation 1.99	-2.82 units on a scale Standard Deviation 2.54	-2.38 units on a scale Standard Deviation 2.72	-1.83 units on a scale Standard Deviation 2.18
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Change at Week 10	-2.06 units on a scale Standard Deviation 2.16	-2.92 units on a scale Standard Deviation 2.62	-2.39 units on a scale Standard Deviation 2.72	-1.89 units on a scale Standard Deviation 2.23
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Change at Week 12	-2.07 units on a scale Standard Deviation 2.27	-2.94 units on a scale Standard Deviation 2.60	-2.38 units on a scale Standard Deviation 2.67	-1.88 units on a scale Standard Deviation 2.33
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population Change at Week 16	-2.09 units on a scale Standard Deviation 2.31	-2.90 units on a scale Standard Deviation 2.63	-2.39 units on a scale Standard Deviation 2.68	-1.86 units on a scale Standard Deviation 2.28

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.

Outcome measures

Outcome measures
Measure	Placebo n=134 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=152 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=147 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=153 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Change at Week 2	-1.23 units on a scale Standard Deviation 1.59	-1.99 units on a scale Standard Deviation 2.19	-1.51 units on a scale Standard Deviation 2.10	-1.46 units on a scale Standard Deviation 1.96
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Baseline	7.16 units on a scale Standard Deviation 1.81	7.31 units on a scale Standard Deviation 1.62	6.98 units on a scale Standard Deviation 1.84	7.05 units on a scale Standard Deviation 1.71
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Change at Week 4	-1.63 units on a scale Standard Deviation 1.85	-2.70 units on a scale Standard Deviation 2.42	-2.21 units on a scale Standard Deviation 2.52	-1.70 units on a scale Standard Deviation 2.10
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Change at Week 1	-0.79 units on a scale Standard Deviation 1.24	-1.71 units on a scale Standard Deviation 1.96	-1.50 units on a scale Standard Deviation 1.81	-1.16 units on a scale Standard Deviation 1.64
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Change at Week 3	-1.54 units on a scale Standard Deviation 1.74	-2.28 units on a scale Standard Deviation 2.31	-1.73 units on a scale Standard Deviation 2.20	-1.58 units on a scale Standard Deviation 2.07
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Change at Week 6	-1.78 units on a scale Standard Deviation 1.96	-2.92 units on a scale Standard Deviation 2.48	-2.37 units on a scale Standard Deviation 2.58	-1.85 units on a scale Standard Deviation 2.17
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Change at Week 8	-1.82 units on a scale Standard Deviation 2.00	-2.88 units on a scale Standard Deviation 2.50	-2.36 units on a scale Standard Deviation 2.63	-1.78 units on a scale Standard Deviation 2.16
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Change at Week 10	-1.95 units on a scale Standard Deviation 2.17	-2.98 units on a scale Standard Deviation 2.56	-2.40 units on a scale Standard Deviation 2.63	-1.83 units on a scale Standard Deviation 2.20
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Change at Week 12	-1.96 units on a scale Standard Deviation 2.27	-3.00 units on a scale Standard Deviation 2.53	-2.36 units on a scale Standard Deviation 2.61	-1.83 units on a scale Standard Deviation 2.27
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population Change at Week 16	-1.96 units on a scale Standard Deviation 2.31	-2.97 units on a scale Standard Deviation 2.55	-2.40 units on a scale Standard Deviation 2.63	-1.84 units on a scale Standard Deviation 2.23

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

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/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 12	-2.15 units on a scale Standard Deviation 2.35	-3.33 units on a scale Standard Deviation 2.75	-3.31 units on a scale Standard Deviation 2.72	-2.25 units on a scale Standard Deviation 2.45
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Baseline	7.22 units on a scale Standard Deviation 1.67	7.30 units on a scale Standard Deviation 1.92	7.15 units on a scale Standard Deviation 1.82	7.39 units on a scale Standard Deviation 1.72
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 2	-1.49 units on a scale Standard Deviation 1.83	-2.24 units on a scale Standard Deviation 2.50	-2.19 units on a scale Standard Deviation 2.41	-1.78 units on a scale Standard Deviation 2.16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 4	-1.88 units on a scale Standard Deviation 1.95	-3.12 units on a scale Standard Deviation 2.70	-3.08 units on a scale Standard Deviation 2.91	-2.16 units on a scale Standard Deviation 2.35
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 8	-1.92 units on a scale Standard Deviation 2.17	-3.09 units on a scale Standard Deviation 2.60	-3.28 units on a scale Standard Deviation 2.77	-2.19 units on a scale Standard Deviation 2.43
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 16	-2.20 units on a scale Standard Deviation 2.50	-3.24 units on a scale Standard Deviation 2.73	-3.25 units on a scale Standard Deviation 2.66	-2.19 units on a scale Standard Deviation 2.40

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

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/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Baseline	7.22 units on a scale Standard Deviation 1.69	7.29 units on a scale Standard Deviation 1.93	7.16 units on a scale Standard Deviation 1.82	7.39 units on a scale Standard Deviation 1.72
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 2	-1.38 units on a scale Standard Deviation 1.87	-2.08 units on a scale Standard Deviation 2.53	-1.90 units on a scale Standard Deviation 2.26	-1.57 units on a scale Standard Deviation 2.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 4	-1.71 units on a scale Standard Deviation 2.02	-2.91 units on a scale Standard Deviation 2.82	-2.61 units on a scale Standard Deviation 2.90	-1.92 units on a scale Standard Deviation 2.36
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 8	-1.77 units on a scale Standard Deviation 2.14	-2.97 units on a scale Standard Deviation 2.74	-2.72 units on a scale Standard Deviation 2.88	-1.92 units on a scale Standard Deviation 2.34
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 12	-2.01 units on a scale Standard Deviation 2.32	-3.24 units on a scale Standard Deviation 2.88	-2.77 units on a scale Standard Deviation 2.85	-2.06 units on a scale Standard Deviation 2.40
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 16	-2.14 units on a scale Standard Deviation 2.47	-3.24 units on a scale Standard Deviation 2.83	-2.83 units on a scale Standard Deviation 2.87	-2.06 units on a scale Standard Deviation 2.37

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

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

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population Baseline	7.39 units on a scale Standard Deviation 1.32	7.48 units on a scale Standard Deviation 1.43	7.27 units on a scale Standard Deviation 1.40	7.50 units on a scale Standard Deviation 1.33
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 2	-1.71 units on a scale Standard Deviation 1.67	-2.29 units on a scale Standard Deviation 2.21	-2.15 units on a scale Standard Deviation 2.04	-1.94 units on a scale Standard Deviation 1.91
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 4	-2.11 units on a scale Standard Deviation 1.88	-3.24 units on a scale Standard Deviation 2.49	-3.16 units on a scale Standard Deviation 2.58	-2.38 units on a scale Standard Deviation 2.12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 8	-2.23 units on a scale Standard Deviation 2.05	-3.32 units on a scale Standard Deviation 2.40	-3.33 units on a scale Standard Deviation 2.49	-2.35 units on a scale Standard Deviation 2.22
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 12	-2.39 units on a scale Standard Deviation 2.20	-3.49 units on a scale Standard Deviation 2.55	-3.35 units on a scale Standard Deviation 2.45	-2.41 units on a scale Standard Deviation 2.23
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 16	-2.47 units on a scale Standard Deviation 2.33	-3.42 units on a scale Standard Deviation 2.53	-3.34 units on a scale Standard Deviation 2.39	-2.39 units on a scale Standard Deviation 2.20

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

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

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population Baseline	7.38 units on a scale Standard Deviation 1.34	7.50 units on a scale Standard Deviation 1.44	7.28 units on a scale Standard Deviation 1.40	7.51 units on a scale Standard Deviation 1.33
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 2	-1.60 units on a scale Standard Deviation 1.70	-2.14 units on a scale Standard Deviation 2.25	-1.90 units on a scale Standard Deviation 1.96	-1.74 units on a scale Standard Deviation 1.94
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 4	-1.94 units on a scale Standard Deviation 1.93	-2.99 units on a scale Standard Deviation 2.61	-2.64 units on a scale Standard Deviation 2.61	-2.08 units on a scale Standard Deviation 2.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 8	-2.08 units on a scale Standard Deviation 2.03	-3.13 units on a scale Standard Deviation 2.59	-2.79 units on a scale Standard Deviation 2.60	-2.07 units on a scale Standard Deviation 2.16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 12	-2.25 units on a scale Standard Deviation 2.19	-3.34 units on a scale Standard Deviation 2.72	-2.83 units on a scale Standard Deviation 2.60	-2.20 units on a scale Standard Deviation 2.21
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 16	-2.40 units on a scale Standard Deviation 2.36	-3.36 units on a scale Standard Deviation 2.71	-2.92 units on a scale Standard Deviation 2.62	-2.20 units on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 2	-2.01 units on a scale Standard Deviation 2.17	-2.61 units on a scale Standard Deviation 2.53	-2.43 units on a scale Standard Deviation 2.39	-2.27 units on a scale Standard Deviation 2.17
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 4	-2.46 units on a scale Standard Deviation 2.30	-3.54 units on a scale Standard Deviation 2.72	-3.58 units on a scale Standard Deviation 2.86	-2.91 units on a scale Standard Deviation 2.42
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population Baseline	7.58 units on a scale Standard Deviation 1.57	7.80 units on a scale Standard Deviation 1.45	7.67 units on a scale Standard Deviation 1.54	7.70 units on a scale Standard Deviation 1.66
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 8	-2.70 units on a scale Standard Deviation 2.63	-3.75 units on a scale Standard Deviation 2.64	-3.82 units on a scale Standard Deviation 2.86	-2.72 units on a scale Standard Deviation 2.50
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 12	-2.85 units on a scale Standard Deviation 2.72	-3.84 units on a scale Standard Deviation 2.80	-3.85 units on a scale Standard Deviation 2.80	-2.80 units on a scale Standard Deviation 2.58
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 16	-2.91 units on a scale Standard Deviation 2.73	-3.79 units on a scale Standard Deviation 2.75	-3.76 units on a scale Standard Deviation 2.76	-2.72 units on a scale Standard Deviation 2.48

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 2	-1.85 units on a scale Standard Deviation 2.15	-2.47 units on a scale Standard Deviation 2.55	-2.19 units on a scale Standard Deviation 2.28	-1.99 units on a scale Standard Deviation 2.15
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 4	-2.26 units on a scale Standard Deviation 2.34	-3.20 units on a scale Standard Deviation 2.73	-2.98 units on a scale Standard Deviation 2.84	-2.50 units on a scale Standard Deviation 2.37
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population Baseline	7.60 units on a scale Standard Deviation 1.56	7.80 units on a scale Standard Deviation 1.46	7.68 units on a scale Standard Deviation 1.54	7.72 units on a scale Standard Deviation 1.62
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 8	-2.50 units on a scale Standard Deviation 2.59	-3.36 units on a scale Standard Deviation 2.77	-3.19 units on a scale Standard Deviation 2.92	-2.39 units on a scale Standard Deviation 2.33
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 12	-2.66 units on a scale Standard Deviation 2.75	-3.54 units on a scale Standard Deviation 2.92	-3.23 units on a scale Standard Deviation 2.88	-2.56 units on a scale Standard Deviation 2.44
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 16	-2.83 units on a scale Standard Deviation 2.81	-3.57 units on a scale Standard Deviation 2.90	-3.32 units on a scale Standard Deviation 2.90	-2.51 units on a scale Standard Deviation 2.37

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population Baseline	8.59 units on a scale Standard Deviation 1.20	8.39 units on a scale Standard Deviation 1.29	8.45 units on a scale Standard Deviation 1.42	8.53 units on a scale Standard Deviation 1.37
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 2	-2.06 units on a scale Standard Deviation 1.99	-2.34 units on a scale Standard Deviation 2.45	-2.39 units on a scale Standard Deviation 2.40	-2.08 units on a scale Standard Deviation 2.10
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 4	-2.64 units on a scale Standard Deviation 2.12	-3.39 units on a scale Standard Deviation 2.78	-3.48 units on a scale Standard Deviation 2.84	-2.64 units on a scale Standard Deviation 2.31
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 8	-2.77 units on a scale Standard Deviation 2.34	-3.58 units on a scale Standard Deviation 2.81	-3.74 units on a scale Standard Deviation 2.86	-2.51 units on a scale Standard Deviation 2.37
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 12	-2.87 units on a scale Standard Deviation 2.38	-3.70 units on a scale Standard Deviation 2.98	-3.76 units on a scale Standard Deviation 2.87	-2.68 units on a scale Standard Deviation 2.48
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population Change at Week 16	-3.02 units on a scale Standard Deviation 2.55	-3.61 units on a scale Standard Deviation 2.86	-3.75 units on a scale Standard Deviation 2.80	-2.66 units on a scale Standard Deviation 2.45

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using LOCF.

Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population Baseline	8.59 units on a scale Standard Deviation 1.20	8.42 units on a scale Standard Deviation 1.27	8.44 units on a scale Standard Deviation 1.42	8.55 units on a scale Standard Deviation 1.35
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 2	-1.90 units on a scale Standard Deviation 1.98	-2.21 units on a scale Standard Deviation 2.45	-2.06 units on a scale Standard Deviation 2.26	-1.87 units on a scale Standard Deviation 2.16
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 4	-2.44 units on a scale Standard Deviation 2.19	-3.10 units on a scale Standard Deviation 2.82	-2.81 units on a scale Standard Deviation 2.79	-2.24 units on a scale Standard Deviation 2.28
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 8	-2.62 units on a scale Standard Deviation 2.36	-3.25 units on a scale Standard Deviation 2.86	-3.04 units on a scale Standard Deviation 2.86	-2.21 units on a scale Standard Deviation 2.29
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 12	-2.71 units on a scale Standard Deviation 2.45	-3.40 units on a scale Standard Deviation 2.99	-3.11 units on a scale Standard Deviation 2.88	-2.40 units on a scale Standard Deviation 2.44
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population Change at Week 16	-2.91 units on a scale Standard Deviation 2.64	-3.42 units on a scale Standard Deviation 2.92	-3.24 units on a scale Standard Deviation 2.89	-2.40 units on a scale Standard Deviation 2.42

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using baseline observation carried forward (BOCF).

SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Bodily Pain: Baseline	28.43 units on a scale Standard Deviation 13.80	28.80 units on a scale Standard Deviation 14.51	29.08 units on a scale Standard Deviation 15.48	27.23 units on a scale Standard Deviation 14.15
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Bodily Pain: Change at Week 12	6.38 units on a scale Standard Deviation 15.63	12.38 units on a scale Standard Deviation 21.23	8.32 units on a scale Standard Deviation 16.82	6.36 units on a scale Standard Deviation 13.92
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population General Health: Baseline	55.28 units on a scale Standard Deviation 22.21	58.35 units on a scale Standard Deviation 19.26	60.01 units on a scale Standard Deviation 21.71	55.47 units on a scale Standard Deviation 18.53
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population General Health: Change at Week 12	1.89 units on a scale Standard Deviation 10.11	2.22 units on a scale Standard Deviation 9.37	2.85 units on a scale Standard Deviation 10.47	1.21 units on a scale Standard Deviation 10.66
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Physical Function: Baseline	29.09 units on a scale Standard Deviation 18.40	31.80 units on a scale Standard Deviation 19.15	32.14 units on a scale Standard Deviation 18.61	28.55 units on a scale Standard Deviation 17.70
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Physical Function: Change at Week 12	6.03 units on a scale Standard Deviation 15.83	10.88 units on a scale Standard Deviation 21.94	5.57 units on a scale Standard Deviation 15.15	4.05 units on a scale Standard Deviation 13.30
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Role Physical: Baseline	37.81 units on a scale Standard Deviation 22.80	40.72 units on a scale Standard Deviation 24.20	39.46 units on a scale Standard Deviation 21.74	36.75 units on a scale Standard Deviation 21.53
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Role Physical: Change at Week 12	7.14 units on a scale Standard Deviation 17.54	10.83 units on a scale Standard Deviation 22.26	6.17 units on a scale Standard Deviation 16.53	5.62 units on a scale Standard Deviation 18.36
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Vitality: Baseline	46.37 units on a scale Standard Deviation 20.06	48.95 units on a scale Standard Deviation 20.59	47.25 units on a scale Standard Deviation 21.03	45.33 units on a scale Standard Deviation 20.61
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Vitality: Change at Week 12	3.10 units on a scale Standard Deviation 10.58	4.19 units on a scale Standard Deviation 12.99	3.08 units on a scale Standard Deviation 12.33	2.25 units on a scale Standard Deviation 13.99
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Social Function: Baseline	57.36 units on a scale Standard Deviation 26.18	62.34 units on a scale Standard Deviation 27.42	61.58 units on a scale Standard Deviation 26.63	57.91 units on a scale Standard Deviation 25.84
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Social Function: Change at Week 12	5.41 units on a scale Standard Deviation 15.69	5.28 units on a scale Standard Deviation 16.40	4.50 units on a scale Standard Deviation 17.46	4.11 units on a scale Standard Deviation 17.07
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Role Emotional: Baseline	60.22 units on a scale Standard Deviation 31.11	64.70 units on a scale Standard Deviation 31.38	63.89 units on a scale Standard Deviation 30.48	60.81 units on a scale Standard Deviation 30.92
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Role Emotional: Change at Week 12	3.72 units on a scale Standard Deviation 16.01	4.92 units on a scale Standard Deviation 19.58	2.06 units on a scale Standard Deviation 19.09	0.42 units on a scale Standard Deviation 15.19
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Mental Health: Baseline	68.40 units on a scale Standard Deviation 20.39	69.13 units on a scale Standard Deviation 19.60	68.27 units on a scale Standard Deviation 20.37	67.59 units on a scale Standard Deviation 19.26
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population Mental Health: Change at Week 12	1.03 units on a scale Standard Deviation 9.77	1.37 units on a scale Standard Deviation 10.61	2.20 units on a scale Standard Deviation 10.61	0.70 units on a scale Standard Deviation 12.00

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using BOCF.

SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Mental Health: Baseline	68.03 units on a scale Standard Deviation 20.53	69.22 units on a scale Standard Deviation 19.57	68.36 units on a scale Standard Deviation 20.41	67.53 units on a scale Standard Deviation 19.36
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population General Health: Baseline	55.61 units on a scale Standard Deviation 22.01	59.08 units on a scale Standard Deviation 18.43	60.21 units on a scale Standard Deviation 21.64	55.56 units on a scale Standard Deviation 18.60
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population General Health: Change at Week 12	1.85 units on a scale Standard Deviation 9.14	1.39 units on a scale Standard Deviation 8.49	2.61 units on a scale Standard Deviation 9.00	0.74 units on a scale Standard Deviation 8.71
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Physical Function: Baseline	29.18 units on a scale Standard Deviation 18.62	31.54 units on a scale Standard Deviation 19.35	32.29 units on a scale Standard Deviation 18.59	28.50 units on a scale Standard Deviation 17.75
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Physical Function: Change at Week 12	5.36 units on a scale Standard Deviation 15.35	8.84 units on a scale Standard Deviation 19.48	3.76 units on a scale Standard Deviation 13.07	2.82 units on a scale Standard Deviation 11.81
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Role Physical: Baseline	37.73 units on a scale Standard Deviation 23.09	41.30 units on a scale Standard Deviation 24.44	39.43 units on a scale Standard Deviation 21.81	36.66 units on a scale Standard Deviation 21.07
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Role Physical: Change at Week 12	6.07 units on a scale Standard Deviation 16.27	9.60 units on a scale Standard Deviation 20.20	5.49 units on a scale Standard Deviation 15.56	4.21 units on a scale Standard Deviation 15.61
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Bodily Pain: Baseline	28.55 units on a scale Standard Deviation 13.96	29.06 units on a scale Standard Deviation 14.52	29.21 units on a scale Standard Deviation 15.45	27.18 units on a scale Standard Deviation 14.06
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Bodily Pain: Change at Week 12	5.54 units on a scale Standard Deviation 14.93	10.53 units on a scale Standard Deviation 20.14	7.41 units on a scale Standard Deviation 16.12	5.14 units on a scale Standard Deviation 12.93
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Vitality: Baseline	46.30 units on a scale Standard Deviation 20.23	48.73 units on a scale Standard Deviation 20.58	47.32 units on a scale Standard Deviation 21.09	45.11 units on a scale Standard Deviation 20.54
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Vitality: Change at Week 12	2.97 units on a scale Standard Deviation 10.14	4.33 units on a scale Standard Deviation 12.61	3.02 units on a scale Standard Deviation 11.22	1.64 units on a scale Standard Deviation 12.40
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Social Function: Baseline	57.39 units on a scale Standard Deviation 26.15	62.58 units on a scale Standard Deviation 27.64	61.66 units on a scale Standard Deviation 26.70	57.93 units on a scale Standard Deviation 25.76
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Social Function: Change at Week 12	4.65 units on a scale Standard Deviation 15.08	5.07 units on a scale Standard Deviation 15.47	5.12 units on a scale Standard Deviation 16.38	3.29 units on a scale Standard Deviation 15.43
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Role Emotional: Baseline	60.04 units on a scale Standard Deviation 31.35	64.54 units on a scale Standard Deviation 31.10	63.93 units on a scale Standard Deviation 30.58	60.68 units on a scale Standard Deviation 30.92
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Role Emotional: Change at Week 12	3.89 units on a scale Standard Deviation 14.92	4.52 units on a scale Standard Deviation 19.19	2.07 units on a scale Standard Deviation 17.00	-0.11 units on a scale Standard Deviation 11.86
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population Mental Health: Change at Week 12	0.62 units on a scale Standard Deviation 9.44	1.70 units on a scale Standard Deviation 9.82	2.55 units on a scale Standard Deviation 9.09	0.48 units on a scale Standard Deviation 10.06

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using BOCF.

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

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population Mental Component Aggregate: Baseline	-0.28 z-score Standard Deviation 1.27	-0.13 z-score Standard Deviation 1.27	-0.20 z-score Standard Deviation 1.28	-0.28 z-score Standard Deviation 1.27
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population Mental Component Aggregate: Change at Week 12	0.08 z-score Standard Deviation 0.53	0.04 z-score Standard Deviation 0.65	0.07 z-score Standard Deviation 0.72	0.01 z-score Standard Deviation 0.67
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population Physical Component Aggregate: Baseline	-1.99 z-score Standard Deviation 0.72	-1.91 z-score Standard Deviation 0.64	-1.88 z-score Standard Deviation 0.69	-2.03 z-score Standard Deviation 0.64
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population Physical Component Aggregate: Change at Week 12	0.26 z-score Standard Deviation 0.63	0.47 z-score Standard Deviation 0.88	0.28 z-score Standard Deviation 0.57	0.23 z-score Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: mITT analysis set included all participants in ITT analysis set who had Week 8 visit on or before 23 June 2010 (effective date of the US FDA imposed clinical hold). Missing data were imputed using BOCF.

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

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population Mental Component Aggregate: Baseline	-0.30 z-score Standard Deviation 1.27	-0.13 z-score Standard Deviation 1.26	-0.19 z-score Standard Deviation 1.28	-0.29 z-score Standard Deviation 1.27
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population Mental Component Aggregate: Change at Week 12	0.08 z-score Standard Deviation 0.51	0.07 z-score Standard Deviation 0.61	0.11 z-score Standard Deviation 0.64	-0.00 z-score Standard Deviation 0.56
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population Physical Component Aggregate: Baseline	-1.98 z-score Standard Deviation 0.72	-1.90 z-score Standard Deviation 0.65	-1.88 z-score Standard Deviation 0.69	-2.03 z-score Standard Deviation 0.63
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population Physical Component Aggregate: Change at Week 12	0.23 z-score Standard Deviation 0.60	0.38 z-score Standard Deviation 0.78	0.22 z-score Standard Deviation 0.53	0.18 z-score Standard Deviation 0.51

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Outcome measures
Measure	Placebo n=140 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population Baseline	0.39 units on a scale Standard Deviation 0.31	0.41 units on a scale Standard Deviation 0.31	0.43 units on a scale Standard Deviation 0.29	0.38 units on a scale Standard Deviation 0.30
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population Change at Week 12	0.25 units on a scale Standard Deviation 0.36	0.33 units on a scale Standard Deviation 0.34	0.22 units on a scale Standard Deviation 0.31	0.14 units on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: mITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Outcome measures
Measure	Placebo n=136 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population Baseline	0.40 units on a scale Standard Deviation 0.31	0.41 units on a scale Standard Deviation 0.31	0.43 units on a scale Standard Deviation 0.30	0.38 units on a scale Standard Deviation 0.30
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population Change at Week 12	0.25 units on a scale Standard Deviation 0.36	0.33 units on a scale Standard Deviation 0.34	0.22 units on a scale Standard Deviation 0.31	0.14 units on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.

Outcome measures

Outcome measures
Measure	Placebo n=140 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Anxiety and Depression, Baseline: Level 1	79 Participants	86 Participants	92 Participants	84 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Mobility, Baseline: Level 1	8 Participants	15 Participants	10 Participants	7 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Mobility, Baseline: Level 2	132 Participants	146 Participants	140 Participants	148 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Mobility, Baseline: Level 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Mobility, Change at Wk 12: Improved	12 Participants	29 Participants	17 Participants	4 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Mobility, Change at Wk 12: No Change	43 Participants	31 Participants	39 Participants	53 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Mobility, Change at Wk 12: Worsened	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Self-care, Baseline: Level 1	93 Participants	122 Participants	99 Participants	108 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Self-care, Baseline: Level 2	45 Participants	38 Participants	50 Participants	48 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Self-care, Baseline: Level 3	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Self-care, Change at Week 12: Improved	15 Participants	12 Participants	17 Participants	10 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Self-care, Change at Week 12: No Change	39 Participants	46 Participants	38 Participants	44 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Self-care, Change at Week 12: Worsened	2 Participants	3 Participants	2 Participants	5 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Usual Activities, Baseline: Level 1	15 Participants	21 Participants	19 Participants	15 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Usual Activities, Baseline: Level 2	123 Participants	134 Participants	125 Participants	136 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Usual Activities, Baseline: Level 3	2 Participants	6 Participants	6 Participants	5 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Usual Activities, Change at Week 12: Improved	15 Participants	27 Participants	15 Participants	21 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Usual Activities, Change at Week 12: No Change	36 Participants	32 Participants	41 Participants	36 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Usual Activities, Change at Week 12: Worsened	5 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Pain and Discomfort, Baseline: Level 1	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Pain and Discomfort, Baseline: Level 2	77 Participants	92 Participants	94 Participants	83 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Pain and Discomfort, Baseline: Level 3	60 Participants	68 Participants	55 Participants	72 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Pain and Discomfort, Change at Week 12: Improved	23 Participants	32 Participants	21 Participants	17 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Pain and Discomfort, Change at Week 12: No Change	29 Participants	28 Participants	35 Participants	39 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Pain and Discomfort, Change at Week 12: Worsened	3 Participants	1 Participants	1 Participants	3 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Anxiety and Depression, Baseline: Level 2	52 Participants	68 Participants	52 Participants	68 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Anxiety and Depression, Baseline: Level 3	9 Participants	7 Participants	5 Participants	4 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Anxiety and Depression, Change at Week 12: Improved	16 Participants	16 Participants	12 Participants	9 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Anxiety and Depression, Change at Week 12: No Change	35 Participants	40 Participants	37 Participants	42 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population Anxiety and Depression, Change at Week 12: Worsened	5 Participants	5 Participants	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: mITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number anlayzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.

Outcome measures

Outcome measures
Measure	Placebo n=136 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=153 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=149 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Mobility, Change at Week 12: No Change	43 Participants	31 Participants	39 Participants	53 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population SC, Baseline: Level 1	91 Participants	118 Participants	99 Participants	108 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Self-care, Baseline: Level 3	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Self-care, Change at Week 12: No Change	39 Participants	46 Participants	38 Participants	44 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Pain and Discomfort, Baseline: Level 1	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Pain and Discomfort, Baseline: Level 3	56 Participants	65 Participants	55 Participants	71 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Anxiety and Depression, Baseline: Level 2	51 Participants	64 Participants	51 Participants	67 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Anxiety and Depression, Change at Week 12: Improved	16 Participants	16 Participants	12 Participants	9 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Usual Activities, Baseline: Level 2	119 Participants	128 Participants	124 Participants	134 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Mobility, Baseline: Level 1	8 Participants	14 Participants	10 Participants	7 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Mobility, Baseline: Level 2	128 Participants	139 Participants	139 Participants	146 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Mobility, Baseline: Level 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Mobility, Change at Week 12: Improved	12 Participants	29 Participants	17 Participants	4 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Mobility, Change at Week 12: Worsened	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Self-care, Baseline: Level 2	43 Participants	34 Participants	49 Participants	46 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Self-care, Change at Week 12: Improved	15 Participants	12 Participants	17 Participants	10 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Self-care, Change at Week 12: Worsened	2 Participants	3 Participants	2 Participants	5 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Usual Activities, Baseline: Level 1	15 Participants	20 Participants	19 Participants	15 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Usual Activities, Baseline: Level 3	2 Participants	5 Participants	6 Participants	5 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Usual Activities, Change at Week 12: Improved	15 Participants	27 Participants	15 Participants	21 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Usual Activities, Change at Week 12: No Change	36 Participants	32 Participants	41 Participants	36 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Usual Activities, Change at Week 12: Worsened	5 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Pain and Discomfort, Baseline: Level 2	77 Participants	87 Participants	93 Participants	82 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Pain and Discomfort, Change at Week 12: Improved	23 Participants	32 Participants	21 Participants	17 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Pain and Discomfort, Change at Week 12: No Change	29 Participants	28 Participants	35 Participants	39 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Pain and Discomfort, Change at Week 12: Worsened	3 Participants	1 Participants	1 Participants	3 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Anxiety and Depression, Baseline: Level 1	76 Participants	82 Participants	92 Participants	83 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Anxiety and Depression, Baseline: Level 3	9 Participants	7 Participants	5 Participants	4 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Anxiety and Depression, Change at Week 12: No Change	35 Participants	40 Participants	37 Participants	42 Participants
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population Anxiety and Depression, Change at Week 12: Worsened	5 Participants	5 Participants	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

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

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants Who Discontinued From Study Due to Lack of Efficacy	10 Participants	6 Participants	5 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: Analysis set included participants from ITT analysis set who discontinued study due to lack of efficacy.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=6 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=5 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=12 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Time to Discontinuation From Study Due to Lack of Efficacy	29.0 days Interval 8.0 to 182.0	43.0 days Interval 15.0 to 84.0	56.0 days Interval 22.0 to 106.0	30.0 days Interval 11.0 to 152.0

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of randomized intravenous study medication (either tanezumab or placebo). Missing data were imputed using LOCF.

In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Rescue Medication (RM) Usage Week 2	90 Participants	85 Participants	99 Participants	90 Participants
Number of Participants With Rescue Medication (RM) Usage Week 4	76 Participants	65 Participants	79 Participants	85 Participants
Number of Participants With Rescue Medication (RM) Usage Week 8	67 Participants	63 Participants	65 Participants	77 Participants
Number of Participants With Rescue Medication (RM) Usage Week 12	68 Participants	52 Participants	61 Participants	78 Participants
Number of Participants With Rescue Medication (RM) Usage Week 16	68 Participants	50 Participants	59 Participants	72 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set. Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are shown in number of days of rescue medication usage per week.

Outcome measures

Outcome measures
Measure	Placebo n=132 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=147 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=144 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=151 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Days With Rescue Medication (RM) Usage Week 16	1.73 days per week Standard Deviation 2.30	1.02 days per week Standard Deviation 1.99	1.40 days per week Standard Deviation 2.25	1.67 days per week Standard Deviation 2.39
Number of Days With Rescue Medication (RM) Usage Week 2	2.72 days per week Standard Deviation 2.66	2.03 days per week Standard Deviation 2.46	2.58 days per week Standard Deviation 2.58	2.35 days per week Standard Deviation 2.69
Number of Days With Rescue Medication (RM) Usage Week 4	2.40 days per week Standard Deviation 2.72	1.60 days per week Standard Deviation 2.43	1.95 days per week Standard Deviation 2.51	2.27 days per week Standard Deviation 2.68
Number of Days With Rescue Medication (RM) Usage Week 8	2.11 days per week Standard Deviation 2.65	1.33 days per week Standard Deviation 2.24	1.72 days per week Standard Deviation 2.52	1.75 days per week Standard Deviation 2.38
Number of Days With Rescue Medication (RM) Usage Week 12	1.82 days per week Standard Deviation 2.39	1.20 days per week Standard Deviation 2.24	1.63 days per week Standard Deviation 2.41	1.74 days per week Standard Deviation 2.37

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: ITT analysis set. Missing data were imputed using LOCF. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are presented as total dose of acetaminophen (in mg) per week.

Outcome measures

Outcome measures
Measure	Placebo n=132 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=147 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=144 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=151 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Amount of Rescue Medication Used Week 8	3000.00 mg per week Standard Deviation 4277.85	1659.86 mg per week Standard Deviation 3092.18	2336.81 mg per week Standard Deviation 4033.87	2539.74 mg per week Standard Deviation 4653.86
Amount of Rescue Medication Used Week 2	4109.38 mg per week Standard Deviation 5190.82	2684.03 mg per week Standard Deviation 4193.21	3510.56 mg per week Standard Deviation 4321.51	3553.33 mg per week Standard Deviation 5395.79
Amount of Rescue Medication Used Week 4	3293.89 mg per week Standard Deviation 4412.77	2136.99 mg per week Standard Deviation 3741.44	2614.58 mg per week Standard Deviation 4221.46	3373.33 mg per week Standard Deviation 4886.01
Amount of Rescue Medication Used Week 12	2561.07 mg per week Standard Deviation 3651.14	1394.56 mg per week Standard Deviation 2893.80	2333.33 mg per week Standard Deviation 4189.56	2360.93 mg per week Standard Deviation 3786.45
Amount of Rescue Medication Used Week 16	2412.88 mg per week Standard Deviation 3416.67	1159.86 mg per week Standard Deviation 2619.07	1965.28 mg per week Standard Deviation 3865.60	2420.53 mg per week Standard Deviation 4121.12

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 18

Population: ITT analysis set. Missing data were imputed using LOCF. Here 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total NIS score is the sum of the left and right limb scores. Total possible NIS score range 0 to 244, higher score=greater impairment.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18 Change at Week 16	-0.40 units on a scale Standard Deviation 1.94	-0.14 units on a scale Standard Deviation 3.78	-0.28 units on a scale Standard Deviation 1.74	-0.53 units on a scale Standard Deviation 2.38
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18 Baseline	1.43 units on a scale Standard Deviation 4.93	1.01 units on a scale Standard Deviation 3.11	1.32 units on a scale Standard Deviation 5.83	1.73 units on a scale Standard Deviation 4.10
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18 Change at Week 2	-0.42 units on a scale Standard Deviation 3.04	-0.22 units on a scale Standard Deviation 1.40	-0.13 units on a scale Standard Deviation 0.79	-0.16 units on a scale Standard Deviation 1.09
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18 Change at Week 4	-0.09 units on a scale Standard Deviation 1.45	-0.33 units on a scale Standard Deviation 2.00	-0.28 units on a scale Standard Deviation 1.68	-0.31 units on a scale Standard Deviation 1.59
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18 Change at Week 8	-0.18 units on a scale Standard Deviation 1.93	-0.22 units on a scale Standard Deviation 2.07	-0.22 units on a scale Standard Deviation 1.51	-0.39 units on a scale Standard Deviation 2.32
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18 Change at Week 12	-0.19 units on a scale Standard Deviation 1.29	-0.13 units on a scale Standard Deviation 4.13	-0.33 units on a scale Standard Deviation 1.81	-0.33 units on a scale Standard Deviation 1.79
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18 Change at Week 18	-0.25 units on a scale Standard Deviation 1.25	-0.02 units on a scale Standard Deviation 2.91	-0.25 units on a scale Standard Deviation 1.64	-0.18 units on a scale Standard Deviation 2.13

SECONDARY outcome

Timeframe: Baseline, Week 8 and 18

Population: ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure. A participant may be represented in more than 1 category.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=144 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA) Baseline	0 Participants	1 Participants	—	—
Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA) Week 8	1 Participants	2 Participants	—	—
Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA) Week 18	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to 112 days after last intravenous dose

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

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	50 Participants	72 Participants	61 Participants	100 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	4 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline up to 112 days after last intravenous dose

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

Pre-specified opioid-related adverse events: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty urinating, confusion and vomiting. Number of participants who experienced any of the pre-specified opioid-related adverse event are reported. Pre-specified opioid-related adverse events were assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity Fatigue: Mild	0 Participants	2 Participants	1 Participants	6 Participants
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity Fatigue: Moderate	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity Nausea: Mild	0 Participants	5 Participants	3 Participants	14 Participants
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity Nausea: Moderate	0 Participants	1 Participants	0 Participants	11 Participants
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity Dizziness: Mild	2 Participants	2 Participants	3 Participants	10 Participants
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity Constipation: Mild	1 Participants	1 Participants	1 Participants	16 Participants
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity Constipation: Moderate	1 Participants	1 Participants	0 Participants	8 Participants
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity Vomiting: Mild	1 Participants	0 Participants	0 Participants	10 Participants
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity Vomiting: Moderate	0 Participants	1 Participants	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline up to 112 days after last intravenous dose

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

Adverse event of abnormal peripheral sensation: allodynia, burning sensation, decreased vibratory sense, dysaesthesia, hyperaesthesia, hyperpathia, hypoaesthesia, neuralgia, neuritis, neuropathy peripheral, pallanesthesia, paraesthesia, paraesthesia oral, peripheral sensory neuropathy, polyneuropathy, sensory disturbance, sensory loss and thermohypoaesthesia. Adverse event of abnormal peripheral sensation was assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Decreased Vibratory Sense: Mild	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Hypoaesthesia: Mild	0 Participants	1 Participants	3 Participants	2 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Burning Sensation: Mild	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Dysaesthesia: Mild	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Hyperaesthesia: Mild	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Hyperaesthesia: Moderate	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Hypoaesthesia: Moderate	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Hypoaesthesia: Severe	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Neuropathy peripheral: Moderate	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Paraesthesia: Mild	0 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity Paraesthesia: Moderate	1 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose, 1 hour post-dose on Day 1, Week 8; Week 18

Population: ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Plasma concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure.

Outcome measures

Outcome measures
Measure	Placebo n=157 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=145 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Tanezumab Plasma Concentration Predose, Day 1	36.96 nanogram per milliliter (ng/mL) Standard Deviation 160.10	124.1 nanogram per milliliter (ng/mL) Standard Deviation 601.80	—	—
Tanezumab Plasma Concentration 1 hour post-dose, Day 1	4192 nanogram per milliliter (ng/mL) Standard Deviation 11266	5690 nanogram per milliliter (ng/mL) Standard Deviation 10616	—	—
Tanezumab Plasma Concentration Predose, Week 8	207.0 nanogram per milliliter (ng/mL) Standard Deviation 288.96	402.6 nanogram per milliliter (ng/mL) Standard Deviation 257.29	—	—
Tanezumab Plasma Concentration 1 hour post-dose, Week 8	2259 nanogram per milliliter (ng/mL) Standard Deviation 2349.1	3583 nanogram per milliliter (ng/mL) Standard Deviation 1754.7	—	—
Tanezumab Plasma Concentration Week 18	87.05 nanogram per milliliter (ng/mL) Standard Deviation 135.30	240.2 nanogram per milliliter (ng/mL) Standard Deviation 386.98	—	—

SECONDARY outcome

Timeframe: Predose, 1 hour post-dose on Day 1, Week 8; Predose: Week 18

Population: ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure and 'number analyzed' signifies participants who were evaluable at specified time-point for each treatment arm, respectively.

Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive, and specific immune-affinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=128 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=124 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=119 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Total Nerve Growth Factor (NGF) Serum Concentration Predose, Day 1	58.1 picogram per milliliter (pg/mL) Standard Deviation 205.1	89.3 picogram per milliliter (pg/mL) Standard Deviation 538.1	138.2 picogram per milliliter (pg/mL) Standard Deviation 770.7	38.5 picogram per milliliter (pg/mL) Standard Deviation 10.8
Total Nerve Growth Factor (NGF) Serum Concentration 1 hour post-dose, Day 1	55.8 picogram per milliliter (pg/mL) Standard Deviation 172.9	133.9 picogram per milliliter (pg/mL) Standard Deviation 483.5	163.8 picogram per milliliter (pg/mL) Standard Deviation 565.2	39.0 picogram per milliliter (pg/mL) Standard Deviation 16.7
Total Nerve Growth Factor (NGF) Serum Concentration Predose, Week 8	92.6 picogram per milliliter (pg/mL) Standard Deviation 384.2	2152.2 picogram per milliliter (pg/mL) Standard Deviation 1040.8	3160.6 picogram per milliliter (pg/mL) Standard Deviation 1183.4	45.5 picogram per milliliter (pg/mL) Standard Deviation 13.2
Total Nerve Growth Factor (NGF) Serum Concentration 1 hour post-dose, Week 8	39.8 picogram per milliliter (pg/mL) Standard Deviation 9.9	2181.2 picogram per milliliter (pg/mL) Standard Deviation 1070.5	3026.0 picogram per milliliter (pg/mL) Standard Deviation 976.1	44.0 picogram per milliliter (pg/mL) Standard Deviation 22.0
Total Nerve Growth Factor (NGF) Serum Concentration Predose, Week 18	41.0 picogram per milliliter (pg/mL) Standard Deviation 15.2	1437.1 picogram per milliliter (pg/mL) Standard Deviation 1296.0	2365.4 picogram per milliliter (pg/mL) Standard Deviation 1402.4	48.7 picogram per milliliter (pg/mL) Standard Deviation 25.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Week 16

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

Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone controlled released (CR) tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=161 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1 and Week 8, along with placebo matched to oxycodone CR tablet orally twice daily up to Week 16.	Oxycodone CR n=158 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1 and Week 8, along with oxycodone CR tablet at a starting dose of 10 mg orally twice daily up to Week 16. Oxycodone dose was adjusted according to the pain relief and tolerability up to a maximum of 40 mg orally twice daily.
Number of Participants With Intravenous (IV) Doses of Study Medication Number of IV Doses: 1	79 Participants	89 Participants	85 Participants	97 Participants
Number of Participants With Intravenous (IV) Doses of Study Medication Number of IV Doses: 2	62 Participants	72 Participants	65 Participants	61 Participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Tanezumab 5 mg

Serious events: 4 serious events

Other events: 43 other events

Deaths: 0 deaths

Tanezumab 10 mg

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Oxycodone CR

Serious events: 4 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

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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