Trial Outcomes & Findings for Tanezumab in Osteoarthritis Of The Hip (NCT NCT00744471)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

627 participants

Primary outcome timeframe

Baseline (Day 1), Week 16

Results posted on

2021-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Study STARTED	156	156	158	157
Overall Study Treated	155	155	154	157
Overall Study COMPLETED	13	11	6	9
Overall Study NOT COMPLETED	143	145	152	148

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Study Randomized but not treated	1	1	4	0
Overall Study Death	0	0	0	1
Overall Study Adverse Event	6	7	5	9
Overall Study Withdrawal by Subject	9	9	15	12
Overall Study Protocol Violation	1	4	1	2
Overall Study Entered extension study	41	84	100	91
Overall Study Other	2	3	6	2
Overall Study Lack of Efficacy	83	37	19	31
Overall Study Lost to Follow-up	0	0	2	0

Baseline Characteristics

Tanezumab in Osteoarthritis Of The Hip

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=155 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=154 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=157 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Total n=621 Participants Total of all reporting groups
Age, Customized <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized Between 18 and 44 years	11 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	6 Participants n=4 Participants	36 Participants n=21 Participants
Age, Customized Between 45 and 64 years	84 Participants n=5 Participants	86 Participants n=7 Participants	74 Participants n=5 Participants	82 Participants n=4 Participants	326 Participants n=21 Participants
Age, Customized >= 65 years	60 Participants n=5 Participants	61 Participants n=7 Participants	69 Participants n=5 Participants	69 Participants n=4 Participants	259 Participants n=21 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	101 Participants n=7 Participants	92 Participants n=5 Participants	88 Participants n=4 Participants	384 Participants n=21 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	54 Participants n=7 Participants	62 Participants n=5 Participants	69 Participants n=4 Participants	237 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), Week 16

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

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

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) Baseline	7.26 Units on a scale Standard Deviation 1.39	7.20 Units on a scale Standard Deviation 1.44	7.24 Units on a scale Standard Deviation 1.46	7.33 Units on a scale Standard Deviation 1.64
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.65 Units on a scale Standard Deviation 2.44	-2.86 Units on a scale Standard Deviation 2.73	-3.35 Units on a scale Standard Deviation 2.76	-3.37 Units on a scale Standard Deviation 2.80

PRIMARY outcome

Timeframe: Baseline, Week 16

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) Baseline	6.79 Units on a scale Standard Deviation 1.56	6.79 Units on a scale Standard Deviation 1.63	6.82 Units on a scale Standard Deviation 1.70	6.83 Units on a scale Standard Deviation 1.83
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.39 Units on a scale Standard Deviation 2.25	-2.54 Units on a scale Standard Deviation 2.72	-2.88 Units on a scale Standard Deviation 2.70	-2.96 Units on a scale Standard Deviation 2.68

PRIMARY outcome

Timeframe: Baseline, Week 16

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

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

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) Baseline	3.47 Units on a scale Standard Deviation 0.60	3.55 Units on a scale Standard Deviation 0.62	3.51 Units on a scale Standard Deviation 0.64	3.46 Units on a scale Standard Deviation 0.66
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) Change at Week 16	-0.34 Units on a scale Standard Deviation 0.69	-0.67 Units on a scale Standard Deviation 0.87	-0.80 Units on a scale Standard Deviation 1.00	-0.80 Units on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.94 Units on a scale Standard Deviation 2.08	-3.32 Units on a scale Standard Deviation 2.59	-3.71 Units on a scale Standard Deviation 2.53	-3.30 Units on a scale Standard Deviation 2.52
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.92 Units on a scale Standard Deviation 2.17	-3.46 Units on a scale Standard Deviation 2.64	-3.99 Units on a scale Standard Deviation 2.63	-3.88 Units on a scale Standard Deviation 2.74
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.74 Units on a scale Standard Deviation 2.33	-2.76 Units on a scale Standard Deviation 2.62	-3.36 Units on a scale Standard Deviation 2.60	-3.70 Units on a scale Standard Deviation 2.71
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.81 Units on a scale Standard Deviation 2.44	-3.24 Units on a scale Standard Deviation 2.89	-3.67 Units on a scale Standard Deviation 2.79	-3.77 Units on a scale Standard Deviation 2.98
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.45 Units on a scale Standard Deviation 2.43	-2.54 Units on a scale Standard Deviation 2.74	-3.00 Units on a scale Standard Deviation 2.80	-3.06 Units on a scale Standard Deviation 2.80

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF) Change at Week 2	-1.94 Units on a scale Standard Deviation 2.08	-3.32 Units on a scale Standard Deviation 2.59	-3.71 Units on a scale Standard Deviation 2.53	-3.30 Units on a scale Standard Deviation 2.52
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF) Change at Week 4	-2.02 Units on a scale Standard Deviation 2.18	-3.55 Units on a scale Standard Deviation 2.59	-4.04 Units on a scale Standard Deviation 2.60	-4.04 Units on a scale Standard Deviation 2.59
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF) Change at Week 8	-1.86 Units on a scale Standard Deviation 2.32	-2.95 Units on a scale Standard Deviation 2.50	-3.52 Units on a scale Standard Deviation 2.61	-3.89 Units on a scale Standard Deviation 2.69
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF) Change at Week 12	-2.12 Units on a scale Standard Deviation 2.48	-3.58 Units on a scale Standard Deviation 2.71	-4.03 Units on a scale Standard Deviation 2.67	-4.35 Units on a scale Standard Deviation 2.69
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF) Change at Week 16	-2.05 Units on a scale Standard Deviation 2.47	-3.23 Units on a scale Standard Deviation 2.59	-3.66 Units on a scale Standard Deviation 2.74	-3.96 Units on a scale Standard Deviation 2.61
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF) Change at Week 24	-1.97 Units on a scale Standard Deviation 2.50	-3.16 Units on a scale Standard Deviation 2.62	-3.56 Units on a scale Standard Deviation 2.74	-3.77 Units on a scale Standard Deviation 2.60

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 24

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.56 Units on a scale Standard Deviation 2.01	-2.88 Units on a scale Standard Deviation 2.53	-3.32 Units on a scale Standard Deviation 2.50	-2.90 Units on a scale Standard Deviation 2.46
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.44 Units on a scale Standard Deviation 1.99	-3.06 Units on a scale Standard Deviation 2.60	-3.62 Units on a scale Standard Deviation 2.43	-3.40 Units on a scale Standard Deviation 2.57
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.33 Units on a scale Standard Deviation 2.21	-2.48 Units on a scale Standard Deviation 2.66	-2.95 Units on a scale Standard Deviation 2.45	-3.17 Units on a scale Standard Deviation 2.61
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.52 Units on a scale Standard Deviation 2.19	-2.86 Units on a scale Standard Deviation 2.86	-3.27 Units on a scale Standard Deviation 2.71	-3.39 Units on a scale Standard Deviation 2.85
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.27 Units on a scale Standard Deviation 2.18	-2.19 Units on a scale Standard Deviation 2.65	-2.62 Units on a scale Standard Deviation 2.61	-2.78 Units on a scale Standard Deviation 2.67

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 2	-1.56 Units on a scale Standard Deviation 2.01	-2.88 Units on a scale Standard Deviation 2.53	-3.32 Units on a scale Standard Deviation 2.50	-2.90 Units on a scale Standard Deviation 2.46
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 4	-1.51 Units on a scale Standard Deviation 2.05	-3.13 Units on a scale Standard Deviation 2.59	-3.67 Units on a scale Standard Deviation 2.43	-3.52 Units on a scale Standard Deviation 2.48
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 8	-1.40 Units on a scale Standard Deviation 2.24	-2.66 Units on a scale Standard Deviation 2.64	-3.14 Units on a scale Standard Deviation 2.44	-3.35 Units on a scale Standard Deviation 2.64
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 12	-1.61 Units on a scale Standard Deviation 2.39	-3.12 Units on a scale Standard Deviation 2.82	-3.58 Units on a scale Standard Deviation 2.63	-3.85 Units on a scale Standard Deviation 2.68
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 16	-1.56 Units on a scale Standard Deviation 2.41	-2.83 Units on a scale Standard Deviation 2.72	-3.16 Units on a scale Standard Deviation 2.72	-3.42 Units on a scale Standard Deviation 2.60
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 24	-1.46 Units on a scale Standard Deviation 2.42	-2.71 Units on a scale Standard Deviation 2.71	-3.09 Units on a scale Standard Deviation 2.61	-3.34 Units on a scale Standard Deviation 2.56

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-0.41 Units on a scale Standard Deviation 0.83	-0.83 Units on a scale Standard Deviation 0.94	-1.08 Units on a scale Standard Deviation 1.02	-0.81 Units on a scale Standard Deviation 0.92
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-0.44 Units on a scale Standard Deviation 0.79	-0.93 Units on a scale Standard Deviation 0.88	-1.16 Units on a scale Standard Deviation 0.96	-0.97 Units on a scale Standard Deviation 0.98
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-0.43 Units on a scale Standard Deviation 0.86	-0.65 Units on a scale Standard Deviation 0.93	-0.93 Units on a scale Standard Deviation 1.03	-0.86 Units on a scale Standard Deviation 0.94
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-0.41 Units on a scale Standard Deviation 0.76	-0.78 Units on a scale Standard Deviation 0.93	-1.03 Units on a scale Standard Deviation 1.05	-0.92 Units on a scale Standard Deviation 0.96
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-0.36 Units on a scale Standard Deviation 0.72	-0.61 Units on a scale Standard Deviation 0.84	-0.78 Units on a scale Standard Deviation 1.00	-0.60 Units on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 2	-0.41 Units on a scale Standard Deviation 0.83	-0.83 Units on a scale Standard Deviation 0.94	-1.08 Units on a scale Standard Deviation 1.02	-0.81 Units on a scale Standard Deviation 0.92
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 4	-0.45 Units on a scale Standard Deviation 0.81	-0.95 Units on a scale Standard Deviation 0.88	-1.17 Units on a scale Standard Deviation 0.97	-1.03 Units on a scale Standard Deviation 0.99
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 8	-0.46 Units on a scale Standard Deviation 0.90	-0.73 Units on a scale Standard Deviation 0.95	-0.96 Units on a scale Standard Deviation 1.04	-0.90 Units on a scale Standard Deviation 0.96
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 12	-0.44 Units on a scale Standard Deviation 0.90	-0.87 Units on a scale Standard Deviation 0.99	-1.14 Units on a scale Standard Deviation 1.05	-1.01 Units on a scale Standard Deviation 1.00
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 16	-0.38 Units on a scale Standard Deviation 0.86	-0.76 Units on a scale Standard Deviation 0.95	-0.89 Units on a scale Standard Deviation 1.05	-0.88 Units on a scale Standard Deviation 0.99
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) Change at Week 24	-0.42 Units on a scale Standard Deviation 0.90	-0.71 Units on a scale Standard Deviation 0.95	-0.90 Units on a scale Standard Deviation 1.08	-0.74 Units on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 16, 24

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

A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (\>=) 50 percent (%)and absolute change of \>=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], higher score=higher pain/difficulty).

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) Week 2	45.5 Percentage of participants	68.7 Percentage of participants	80.0 Percentage of participants	67.7 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) Week 4	45.5 Percentage of participants	71.3 Percentage of participants	79.3 Percentage of participants	74.8 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) Week 8	43.5 Percentage of participants	60.7 Percentage of participants	70.7 Percentage of participants	71.0 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) Week 12	39.6 Percentage of participants	63.3 Percentage of participants	70.0 Percentage of participants	66.5 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) Week 16	35.1 Percentage of participants	57.3 Percentage of participants	65.3 Percentage of participants	65.8 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) Week 24	30.5 Percentage of participants	50.7 Percentage of participants	62.0 Percentage of participants	58.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12 ,16, 24

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

A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (\>=) 50 percent (%)and absolute change of \>=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], higher score=higher pain/difficulty).

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 2	45.5 Percentage of participants	68.7 Percentage of participants	80.0 Percentage of participants	67.7 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 4	48.1 Percentage of participants	73.3 Percentage of participants	81.3 Percentage of participants	78.7 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 8	47.4 Percentage of participants	66.7 Percentage of participants	75.3 Percentage of participants	75.5 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 12	50.0 Percentage of participants	74.0 Percentage of participants	78.0 Percentage of participants	78.1 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 16	48.1 Percentage of participants	68.7 Percentage of participants	72.0 Percentage of participants	77.4 Percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 24	46.1 Percentage of participants	66.7 Percentage of participants	73.3 Percentage of participants	74.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with \>=30% or \>=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 2: >=30% reduction	38.3 Percentage of participants	64.2 Percentage of participants	70.7 Percentage of participants	58.3 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 2: >=50% reduction	26.0 Percentage of participants	49.0 Percentage of participants	50.7 Percentage of participants	44.2 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 4: >=30% reduction	37.7 Percentage of participants	65.6 Percentage of participants	72.0 Percentage of participants	70.5 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 4: >=50% reduction	23.4 Percentage of participants	50.3 Percentage of participants	59.3 Percentage of participants	56.4 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 8: >=30% reduction	36.4 Percentage of participants	59.6 Percentage of participants	66.0 Percentage of participants	68.4 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 8: >= 50% reduction	22.1 Percentage of participants	40.4 Percentage of participants	48.7 Percentage of participants	52.9 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 12: >= 30% reduction	37.7 Percentage of participants	59.6 Percentage of participants	65.3 Percentage of participants	64.7 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 12: >= 50% reduction	26.0 Percentage of participants	49.0 Percentage of participants	53.3 Percentage of participants	59.0 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 16: >= 30% reduction	32.5 Percentage of participants	56.3 Percentage of participants	63.3 Percentage of participants	61.5 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 16: >= 50% reduction	26.0 Percentage of participants	39.7 Percentage of participants	50.7 Percentage of participants	46.2 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 24: >= 30% reduction	27.9 Percentage of participants	47.7 Percentage of participants	57.3 Percentage of participants	57.1 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward Week 24: >= 50% reduction	19.5 Percentage of participants	37.1 Percentage of participants	46.0 Percentage of participants	44.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

Population: mITT analysis set: all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1021. LOCF method was used to impute missing values.

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Percentage of participants with \>=30% or \>=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 2 >= 30% Reduction	38.3 Percentage of participants	64.2 Percentage of participants	70.7 Percentage of participants	58.3 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 2 >= 50% Reduction	26.0 Percentage of participants	49.0 Percentage of participants	50.7 Percentage of participants	44.2 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 4 >= 30% Reduction	39.0 Percentage of participants	66.9 Percentage of participants	74.0 Percentage of participants	73.7 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 4 >= 50% Reduction	24.7 Percentage of participants	51.7 Percentage of participants	59.3 Percentage of participants	57.7 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 8 >= 30% Reduction	38.3 Percentage of participants	63.6 Percentage of participants	69.3 Percentage of participants	71.8 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 8 >= 50% Reduction	22.7 Percentage of participants	41.1 Percentage of participants	50.0 Percentage of participants	54.5 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 12 >= 30% Reduction	44.8 Percentage of participants	67.5 Percentage of participants	72.7 Percentage of participants	75.6 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 12 >= 50% Reduction	27.9 Percentage of participants	52.3 Percentage of participants	58.0 Percentage of participants	66.0 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 16 >= 30% Reduction	41.6 Percentage of participants	64.9 Percentage of participants	69.3 Percentage of participants	72.4 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 16 >= 50% Reduction	28.6 Percentage of participants	43.7 Percentage of participants	54.7 Percentage of participants	53.2 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 24 >= 30% Reduction	39.6 Percentage of participants	60.9 Percentage of participants	68.0 Percentage of participants	71.2 Percentage of participants
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 24 >= 50% Reduction	23.4 Percentage of participants	43.7 Percentage of participants	52.7 Percentage of participants	51.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12 ,16, 24

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

Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF) Week 2	9.7 Percentage of participants	24.0 Percentage of participants	32.0 Percentage of participants	24.5 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF) Week 4	10.4 Percentage of participants	25.3 Percentage of participants	34.0 Percentage of participants	31.6 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF) Week 8	10.4 Percentage of participants	15.3 Percentage of participants	27.3 Percentage of participants	27.1 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF) Week 12	11.7 Percentage of participants	22.0 Percentage of participants	28.7 Percentage of participants	29.7 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF) Week 16	7.1 Percentage of participants	14.7 Percentage of participants	20.0 Percentage of participants	27.7 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF) Week 24	8.4 Percentage of participants	15.3 Percentage of participants	20.7 Percentage of participants	18.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

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

Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) Week 24	9.7 Percentage of participants	19.3 Percentage of participants	25.3 Percentage of participants	23.2 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) Week 2	9.7 Percentage of participants	24.0 Percentage of participants	32.0 Percentage of participants	24.5 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) Week 4	10.4 Percentage of participants	26.0 Percentage of participants	34.7 Percentage of participants	34.2 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) Week 8	11.0 Percentage of participants	18.0 Percentage of participants	28.0 Percentage of participants	28.4 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) Week 12	12.3 Percentage of participants	25.3 Percentage of participants	31.3 Percentage of participants	32.9 Percentage of participants
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) Week 16	8.4 Percentage of participants	18.7 Percentage of participants	23.3 Percentage of participants	30.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) Greater than (>) 0%	44.8 Percentage of participants	68.2 Percentage of participants	78.7 Percentage of participants	72.4 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) >=10%	40.9 Percentage of participants	64.9 Percentage of participants	73.3 Percentage of participants	70.5 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) >=20%	36.4 Percentage of participants	58.9 Percentage of participants	66.7 Percentage of participants	67.3 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) >=30%	32.5 Percentage of participants	56.3 Percentage of participants	63.3 Percentage of participants	61.5 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) >=40%	29.2 Percentage of participants	50.3 Percentage of participants	54.7 Percentage of participants	53.2 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) >=50%	26.0 Percentage of participants	39.7 Percentage of participants	50.7 Percentage of participants	46.2 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) >=60%	19.5 Percentage of participants	35.8 Percentage of participants	43.3 Percentage of participants	39.7 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) >=70%	13.6 Percentage of participants	28.5 Percentage of participants	36.7 Percentage of participants	35.3 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) >=80%	11.0 Percentage of participants	21.9 Percentage of participants	25.3 Percentage of participants	30.1 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) >=90%	4.5 Percentage of participants	13.2 Percentage of participants	18.0 Percentage of participants	20.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >0%	79.2 Percentage of participants	87.4 Percentage of participants	89.3 Percentage of participants	93.6 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >=10%	63.6 Percentage of participants	81.5 Percentage of participants	82.0 Percentage of participants	89.7 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >=20%	50.6 Percentage of participants	70.2 Percentage of participants	74.7 Percentage of participants	81.4 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >=30%	41.6 Percentage of participants	64.9 Percentage of participants	69.3 Percentage of participants	72.4 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >=40%	34.4 Percentage of participants	57.0 Percentage of participants	59.3 Percentage of participants	61.5 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >=50%	28.6 Percentage of participants	43.7 Percentage of participants	54.7 Percentage of participants	53.2 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >=60%	21.4 Percentage of participants	37.7 Percentage of participants	47.3 Percentage of participants	45.5 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >=70%	14.3 Percentage of participants	29.1 Percentage of participants	40.7 Percentage of participants	40.4 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >=80%	11.0 Percentage of participants	21.9 Percentage of participants	28.0 Percentage of participants	34.6 Percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) >=90%	4.5 Percentage of participants	13.2 Percentage of participants	20.0 Percentage of participants	23.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Baseline	6.61 Units on a scale Standard Deviation 1.86	6.44 Units on a scale Standard Deviation 1.89	6.71 Units on a scale Standard Deviation 1.93	6.55 Units on a scale Standard Deviation 1.96
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.24 Units on a scale Standard Deviation 1.97	-1.89 Units on a scale Standard Deviation 2.40	-2.51 Units on a scale Standard Deviation 2.51	-2.03 Units on a scale Standard Deviation 2.57
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.16 Units on a scale Standard Deviation 2.07	-2.44 Units on a scale Standard Deviation 2.42	-3.10 Units on a scale Standard Deviation 2.55	-2.65 Units on a scale Standard Deviation 2.65
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-0.99 Units on a scale Standard Deviation 2.00	-2.00 Units on a scale Standard Deviation 2.37	-2.50 Units on a scale Standard Deviation 2.48	-2.44 Units on a scale Standard Deviation 2.59
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.34 Units on a scale Standard Deviation 2.15	-2.19 Units on a scale Standard Deviation 2.58	-2.84 Units on a scale Standard Deviation 2.62	-2.83 Units on a scale Standard Deviation 2.82
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.18 Units on a scale Standard Deviation 2.06	-2.02 Units on a scale Standard Deviation 2.40	-2.39 Units on a scale Standard Deviation 2.55	-2.56 Units on a scale Standard Deviation 2.64
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-0.97 Units on a scale Standard Deviation 1.90	-1.55 Units on a scale Standard Deviation 2.29	-2.24 Units on a scale Standard Deviation 2.61	-2.12 Units on a scale Standard Deviation 2.59

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12 ,16, 24

Population: mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values.

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), giving an overall possible mean score range of 0 (minimum stiffness) to 10 (maximum stiffness). Higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of hip joint.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Baseline	7.18 Units on a scale Standard Deviation 1.65	7.17 Units on a scale Standard Deviation 1.69	7.02 Units on a scale Standard Deviation 2.01	7.23 Units on a scale Standard Deviation 1.96
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.69 Units on a scale Standard Deviation 2.25	-3.13 Units on a scale Standard Deviation 2.67	-3.47 Units on a scale Standard Deviation 3.02	-3.32 Units on a scale Standard Deviation 3.04
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.51 Units on a scale Standard Deviation 2.25	-3.29 Units on a scale Standard Deviation 2.72	-3.80 Units on a scale Standard Deviation 2.89	-3.82 Units on a scale Standard Deviation 3.00
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.34 Units on a scale Standard Deviation 2.41	-2.61 Units on a scale Standard Deviation 2.69	-3.17 Units on a scale Standard Deviation 3.08	-3.46 Units on a scale Standard Deviation 2.97
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.52 Units on a scale Standard Deviation 2.30	-3.05 Units on a scale Standard Deviation 2.95	-3.60 Units on a scale Standard Deviation 3.13	-3.78 Units on a scale Standard Deviation 3.19
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.39 Units on a scale Standard Deviation 2.32	-2.54 Units on a scale Standard Deviation 2.76	-3.09 Units on a scale Standard Deviation 3.00	-3.33 Units on a scale Standard Deviation 2.99
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.32 Units on a scale Standard Deviation 2.35	-2.30 Units on a scale Standard Deviation 2.77	-2.93 Units on a scale Standard Deviation 3.08	-3.16 Units on a scale Standard Deviation 3.04

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

Population: mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values.

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of hip joint. Each item is scored on a 0 (no pain) to 10 (worst possible pain) NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no pain) to 10 (worst possible pain), where higher score indicates worse response.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF) Baseline	7.08 Units on a scale Standard Deviation 1.39	7.05 Units on a scale Standard Deviation 1.42	7.03 Units on a scale Standard Deviation 1.57	7.13 Units on a scale Standard Deviation 1.63
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.73 Units on a scale Standard Deviation 1.97	-3.13 Units on a scale Standard Deviation 2.50	-3.50 Units on a scale Standard Deviation 2.57	-3.17 Units on a scale Standard Deviation 2.55
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.62 Units on a scale Standard Deviation 2.02	-3.27 Units on a scale Standard Deviation 2.54	-3.80 Units on a scale Standard Deviation 2.53	-3.70 Units on a scale Standard Deviation 2.65
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.47 Units on a scale Standard Deviation 2.22	-2.63 Units on a scale Standard Deviation 2.56	-3.17 Units on a scale Standard Deviation 2.57	-3.45 Units on a scale Standard Deviation 2.66
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.62 Units on a scale Standard Deviation 2.23	-3.05 Units on a scale Standard Deviation 2.82	-3.51 Units on a scale Standard Deviation 2.78	-3.65 Units on a scale Standard Deviation 2.93
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.48 Units on a scale Standard Deviation 2.28	-2.65 Units on a scale Standard Deviation 2.65	-3.10 Units on a scale Standard Deviation 2.72	-3.22 Units on a scale Standard Deviation 2.73
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.35 Units on a scale Standard Deviation 2.28	-2.34 Units on a scale Standard Deviation 2.66	-2.85 Units on a scale Standard Deviation 2.72	-3.00 Units on a scale Standard Deviation 2.72

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

Population: mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values.

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 =extreme pain. Higher scores indicated more pain.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.71 Units on a scale Standard Deviation 2.55	-2.84 Units on a scale Standard Deviation 2.73	-3.25 Units on a scale Standard Deviation 2.77	-3.45 Units on a scale Standard Deviation 2.71
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.76 Units on a scale Standard Deviation 2.51	-3.13 Units on a scale Standard Deviation 2.97	-3.65 Units on a scale Standard Deviation 2.90	-3.59 Units on a scale Standard Deviation 2.96
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.56 Units on a scale Standard Deviation 2.43	-2.73 Units on a scale Standard Deviation 2.91	-3.29 Units on a scale Standard Deviation 2.98	-3.21 Units on a scale Standard Deviation 2.81
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.44 Units on a scale Standard Deviation 2.43	-2.45 Units on a scale Standard Deviation 2.78	-2.95 Units on a scale Standard Deviation 2.93	-2.94 Units on a scale Standard Deviation 2.80
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF) Baseline	7.26 Units on a scale Standard Deviation 1.66	7.21 Units on a scale Standard Deviation 1.65	7.25 Units on a scale Standard Deviation 1.61	7.32 Units on a scale Standard Deviation 1.76
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.83 Units on a scale Standard Deviation 2.39	-3.31 Units on a scale Standard Deviation 2.81	-3.79 Units on a scale Standard Deviation 2.71	-3.33 Units on a scale Standard Deviation 2.54
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.96 Units on a scale Standard Deviation 2.38	-3.40 Units on a scale Standard Deviation 2.73	-4.01 Units on a scale Standard Deviation 2.83	-3.75 Units on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

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

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when going up or down the stairs?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = worst possible pain, where higher scores indicating higher pain.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.88 Units on a scale Standard Deviation 2.15	-3.42 Units on a scale Standard Deviation 2.62	-3.89 Units on a scale Standard Deviation 2.85	-3.35 Units on a scale Standard Deviation 2.71
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.84 Units on a scale Standard Deviation 2.26	-3.59 Units on a scale Standard Deviation 2.82	-4.11 Units on a scale Standard Deviation 2.87	-3.82 Units on a scale Standard Deviation 3.03
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.64 Units on a scale Standard Deviation 2.32	-2.87 Units on a scale Standard Deviation 2.84	-3.46 Units on a scale Standard Deviation 2.92	-3.59 Units on a scale Standard Deviation 3.05
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.75 Units on a scale Standard Deviation 2.49	-3.39 Units on a scale Standard Deviation 3.10	-3.80 Units on a scale Standard Deviation 3.08	-3.72 Units on a scale Standard Deviation 3.23
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.56 Units on a scale Standard Deviation 2.50	-2.95 Units on a scale Standard Deviation 3.00	-3.41 Units on a scale Standard Deviation 3.11	-3.21 Units on a scale Standard Deviation 3.03
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.45 Units on a scale Standard Deviation 2.46	-2.54 Units on a scale Standard Deviation 2.92	-2.98 Units on a scale Standard Deviation 3.04	-2.92 Units on a scale Standard Deviation 3.03
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Baseline	7.99 Units on a scale Standard Deviation 1.46	7.94 Units on a scale Standard Deviation 1.51	7.83 Units on a scale Standard Deviation 1.59	7.89 Units on a scale Standard Deviation 1.81

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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

The SF-36 health survey was a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12:General health	2.07 Units on a scale Standard Deviation 9.34	4.01 Units on a scale Standard Deviation 12.61	8.03 Units on a scale Standard Deviation 14.24	5.27 Units on a scale Standard Deviation 13.14
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week12:Physical Function	6.01 Units on a scale Standard Deviation 15.12	15.01 Units on a scale Standard Deviation 21.38	18.52 Units on a scale Standard Deviation 25.16	18.91 Units on a scale Standard Deviation 24.96
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: General health	64.81 Units on a scale Standard Deviation 18.81	67.04 Units on a scale Standard Deviation 18.12	63.74 Units on a scale Standard Deviation 18.60	64.26 Units on a scale Standard Deviation 19.29
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: Physical Function	30.56 Units on a scale Standard Deviation 19.51	29.66 Units on a scale Standard Deviation 20.35	30.78 Units on a scale Standard Deviation 19.69	29.48 Units on a scale Standard Deviation 19.29
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: Role Physical	39.25 Units on a scale Standard Deviation 24.74	36.96 Units on a scale Standard Deviation 24.78	38.83 Units on a scale Standard Deviation 25.33	38.47 Units on a scale Standard Deviation 23.86
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: Bodily Pain	29.70 Units on a scale Standard Deviation 13.96	29.66 Units on a scale Standard Deviation 14.56	29.73 Units on a scale Standard Deviation 15.78	31.25 Units on a scale Standard Deviation 16.27
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: Vitality	47.28 Units on a scale Standard Deviation 21.28	49.42 Units on a scale Standard Deviation 20.93	48.04 Units on a scale Standard Deviation 20.70	46.85 Units on a scale Standard Deviation 22.81
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: Social Function	64.37 Units on a scale Standard Deviation 27.11	66.67 Units on a scale Standard Deviation 25.32	63.67 Units on a scale Standard Deviation 28.76	66.61 Units on a scale Standard Deviation 28.39
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: Role Emotional	63.47 Units on a scale Standard Deviation 30.57	68.94 Units on a scale Standard Deviation 28.34	67.22 Units on a scale Standard Deviation 30.86	68.76 Units on a scale Standard Deviation 30.26
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: Mental Health	72.63 Units on a scale Standard Deviation 18.70	74.30 Units on a scale Standard Deviation 17.76	73.90 Units on a scale Standard Deviation 18.80	73.32 Units on a scale Standard Deviation 19.63
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Role Physical	7.67 Units on a scale Standard Deviation 20.91	16.88 Units on a scale Standard Deviation 23.77	22.83 Units on a scale Standard Deviation 28.70	18.99 Units on a scale Standard Deviation 27.10
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Bodily Pain	10.42 Units on a scale Standard Deviation 17.62	17.97 Units on a scale Standard Deviation 22.08	25.23 Units on a scale Standard Deviation 25.48	22.87 Units on a scale Standard Deviation 26.10
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Vitality	5.24 Units on a scale Standard Deviation 14.14	8.13 Units on a scale Standard Deviation 15.66	10.79 Units on a scale Standard Deviation 19.82	7.86 Units on a scale Standard Deviation 20.03
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12:Social Function	5.52 Units on a scale Standard Deviation 18.91	10.25 Units on a scale Standard Deviation 22.16	12.08 Units on a scale Standard Deviation 24.89	10.08 Units on a scale Standard Deviation 24.88
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12:Role emotional	4.44 Units on a scale Standard Deviation 21.01	8.33 Units on a scale Standard Deviation 19.14	11.72 Units on a scale Standard Deviation 26.93	9.68 Units on a scale Standard Deviation 23.43
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Mental Health	3.77 Units on a scale Standard Deviation 11.86	4.07 Units on a scale Standard Deviation 13.44	5.73 Units on a scale Standard Deviation 15.87	2.55 Units on a scale Standard Deviation 16.15
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24:General health	1.69 Units on a scale Standard Deviation 11.03	3.64 Units on a scale Standard Deviation 10.99	4.70 Units on a scale Standard Deviation 12.88	4.17 Units on a scale Standard Deviation 13.82
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24:Physical Function	6.24 Units on a scale Standard Deviation 16.12	9.97 Units on a scale Standard Deviation 16.87	12.99 Units on a scale Standard Deviation 22.00	14.25 Units on a scale Standard Deviation 21.60
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Role Physical	7.55 Units on a scale Standard Deviation 16.05	12.04 Units on a scale Standard Deviation 20.21	13.88 Units on a scale Standard Deviation 26.31	13.63 Units on a scale Standard Deviation 22.54
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Bodily Pain	9.16 Units on a scale Standard Deviation 17.76	11.39 Units on a scale Standard Deviation 18.79	15.91 Units on a scale Standard Deviation 21.97	14.94 Units on a scale Standard Deviation 21.55
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Vitality	3.77 Units on a scale Standard Deviation 12.01	6.46 Units on a scale Standard Deviation 14.63	6.83 Units on a scale Standard Deviation 17.58	6.61 Units on a scale Standard Deviation 15.31
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24:Social Function	3.73 Units on a scale Standard Deviation 18.25	6.92 Units on a scale Standard Deviation 19.62	8.83 Units on a scale Standard Deviation 22.74	5.73 Units on a scale Standard Deviation 19.60
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24:Role Emotional	3.30 Units on a scale Standard Deviation 17.19	7.72 Units on a scale Standard Deviation 17.80	7.56 Units on a scale Standard Deviation 23.81	5.97 Units on a scale Standard Deviation 22.19
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Mental Health	1.40 Units on a scale Standard Deviation 11.34	3.53 Units on a scale Standard Deviation 13.01	1.73 Units on a scale Standard Deviation 13.94	1.60 Units on a scale Standard Deviation 15.06

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

Population: mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded at a study site. BOCF method was used to impute missing values. Here, 'Overall Number of Participants Analyzed', signified number of participants evaluable for this outcome measure for respective reporting groups.

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

Outcome measures

Outcome measures
Measure	Placebo n=153 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: MCA	-0.03 Units on a scale Standard Deviation 1.20	0.18 Units on a scale Standard Deviation 1.15	0.06 Units on a scale Standard Deviation 1.26	0.11 Units on a scale Standard Deviation 1.29
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Baseline: PCA	-1.90 Units on a scale Standard Deviation 0.72	-1.99 Units on a scale Standard Deviation 0.82	-1.96 Units on a scale Standard Deviation 0.77	-1.97 Units on a scale Standard Deviation 0.76
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: MCA	0.15 Units on a scale Standard Deviation 0.73	0.19 Units on a scale Standard Deviation 0.81	0.26 Units on a scale Standard Deviation 1.02	0.10 Units on a scale Standard Deviation 0.96
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: PCA	0.29 Units on a scale Standard Deviation 0.64	0.66 Units on a scale Standard Deviation 0.90	0.89 Units on a scale Standard Deviation 1.05	0.84 Units on a scale Standard Deviation 1.02
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: MCA	0.04 Units on a scale Standard Deviation 0.69	0.20 Units on a scale Standard Deviation 0.70	0.12 Units on a scale Standard Deviation 0.88	0.04 Units on a scale Standard Deviation 0.87
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: PCA	0.31 Units on a scale Standard Deviation 0.63	0.42 Units on a scale Standard Deviation 0.73	0.60 Units on a scale Standard Deviation 0.91	0.61 Units on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: Baseline up to Week 16

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

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

Outcome measures

Outcome measures
Measure	Placebo n=155 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=154 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=157 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Time to Discontinuation Due to Lack of Efficacy	NA Days Median and full range cannot be estimated due to less number of participants with events.	NA Days Median and full range cannot be estimated due to less number of participants with events.	NA Days Median and full range cannot be estimated due to less number of participants with events.	NA Days Median and full range cannot be estimated due to less number of participants with events.

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12 ,16, 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Percentage of Participants Who Used Rescue Medication Week 2	46.1 Percentage of participants	37.1 Percentage of participants	36.1 Percentage of participants	37.4 Percentage of participants
Percentage of Participants Who Used Rescue Medication Week 4	45.8 Percentage of participants	26.5 Percentage of participants	23.6 Percentage of participants	23.1 Percentage of participants
Percentage of Participants Who Used Rescue Medication Week 8	30.7 Percentage of participants	26.5 Percentage of participants	22.1 Percentage of participants	29.5 Percentage of participants
Percentage of Participants Who Used Rescue Medication Week 12	25.5 Percentage of participants	22.5 Percentage of participants	15.4 Percentage of participants	20.5 Percentage of participants
Percentage of Participants Who Used Rescue Medication Week 16	23.5 Percentage of participants	24.5 Percentage of participants	24.2 Percentage of participants	16.7 Percentage of participants
Percentage of Participants Who Used Rescue Medication Week 24	23.5 Percentage of participants	25.8 Percentage of participants	22.8 Percentage of participants	24.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 16, 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Duration of Rescue Medication Use Week 2	2.0 days Interval 0.0 to 7.0	1.0 days Interval 0.0 to 7.0	1.0 days Interval 0.0 to 7.0	1.0 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 4	2.0 days Interval 0.0 to 7.0	1.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 8	1.0 days Interval 0.0 to 7.0	1.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 12	0.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 16	0.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0	0.0 days Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 16, 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=153 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=151 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=150 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=156 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Amount of Rescue Medication Taken Week 24	2496.73 milligram Standard Deviation 5120.42	2274.83 milligram Standard Deviation 4808.22	2684.56 milligram Standard Deviation 5787.73	1996.79 milligram Standard Deviation 3717.65
Amount of Rescue Medication Taken Week 2	3917.76 milligram Standard Deviation 4859.09	3205.30 milligram Standard Deviation 4485.63	3346.94 milligram Standard Deviation 5405.67	3306.45 milligram Standard Deviation 4470.46
Amount of Rescue Medication Taken Week 4	3676.47 milligram Standard Deviation 4774.68	2437.09 milligram Standard Deviation 3932.47	2148.65 milligram Standard Deviation 4331.68	1919.87 milligram Standard Deviation 3183.88
Amount of Rescue Medication Taken Week 8	3163.40 milligram Standard Deviation 4984.13	2811.26 milligram Standard Deviation 5086.17	2372.48 milligram Standard Deviation 5138.01	2298.08 milligram Standard Deviation 3592.46
Amount of Rescue Medication Taken Week 12	2683.01 milligram Standard Deviation 5597.74	2304.64 milligram Standard Deviation 4477.34	2093.96 milligram Standard Deviation 5141.37	1910.26 milligram Standard Deviation 3648.90
Amount of Rescue Medication Taken Week 16	2366.01 milligram Standard Deviation 4771.42	2350.99 milligram Standard Deviation 4710.91	2382.55 milligram Standard Deviation 5197.90	1666.67 milligram Standard Deviation 3542.07

SECONDARY outcome

Timeframe: Baseline up to Week 32

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

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

Outcome measures

Outcome measures
Measure	Placebo n=155 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=154 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=157 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	68 Participants	90 Participants	84 Participants	89 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	6 Participants	5 Participants	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=155 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=155 Participants Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=154 Participants Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=157 Participants Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24 Change at Week 2	-0.09 Units on a scale Standard Deviation 1.44	-0.22 Units on a scale Standard Deviation 1.92	-0.21 Units on a scale Standard Deviation 1.03	-0.10 Units on a scale Standard Deviation 1.40
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24 Change at Week 4	-0.03 Units on a scale Standard Deviation 2.29	0.03 Units on a scale Standard Deviation 2.32	-0.38 Units on a scale Standard Deviation 1.16	-0.45 Units on a scale Standard Deviation 1.52
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24 Change at Week 8	-0.23 Units on a scale Standard Deviation 2.04	-0.45 Units on a scale Standard Deviation 1.74	-0.38 Units on a scale Standard Deviation 1.60	-0.35 Units on a scale Standard Deviation 1.71
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24 Change at Week 12	-0.23 Units on a scale Standard Deviation 1.16	-0.40 Units on a scale Standard Deviation 1.96	-0.41 Units on a scale Standard Deviation 1.71	-0.47 Units on a scale Standard Deviation 1.45
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24 Change at Week 16	0.07 Units on a scale Standard Deviation 1.48	-0.33 Units on a scale Standard Deviation 2.51	-0.36 Units on a scale Standard Deviation 1.63	-0.40 Units on a scale Standard Deviation 2.07
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24 Change at Week 24	-0.06 Units on a scale Standard Deviation 0.83	-0.17 Units on a scale Standard Deviation 1.72	-0.46 Units on a scale Standard Deviation 1.63	-0.20 Units on a scale Standard Deviation 1.59

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 50 other events

Deaths: 0 deaths

Tanezumab 2.5 mg

Serious events: 5 serious events

Other events: 64 other events

Deaths: 0 deaths

Tanezumab 5 mg

Serious events: 7 serious events

Other events: 58 other events

Deaths: 0 deaths

Tanezumab 10 mg

Serious events: 6 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Serious adverse events
Measure	Placebo n=155 participants at risk Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=155 participants at risk Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=154 participants at risk Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=157 participants at risk Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Synovial sarcoma	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.64% 1/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Haemorrhage intracranial	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Syncope	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Cardiac disorders Atrial flutter	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Cardiac disorders Cardiac arrest	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.64% 1/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Cardiac disorders Cardiopulmonary failure	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Cardiac disorders Coronary artery disease	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.64% 1/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Gastrointestinal disorders Duodenal ulcer	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Gastrointestinal disorders Gastrointestinal oedema	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Gastrointestinal disorders Intestinal obstruction	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Gastrointestinal disorders Umbilical hernia	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
General disorders Oedema peripheral	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.64% 1/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Hepatobiliary disorders Cholelithiasis	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.64% 1/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Cellulitis	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.64% 1/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Periorbital cellulitis	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Pneumonia	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Injury, poisoning and procedural complications Fall	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.64% 1/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Skin and subcutaneous tissue disorders Actinic keratosis	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Vascular disorders Haematoma	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Appendicitis perforated	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492

Other adverse events
Measure	Placebo n=155 participants at risk Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 2.5 mg n=155 participants at risk Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 5 mg n=154 participants at risk Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.	Tanezumab 10 mg n=157 participants at risk Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Gastrointestinal disorders Diarrhoea	1.9% 3/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 5/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Gastrointestinal disorders Nausea	3.9% 6/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
General disorders Oedema peripheral	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	4.5% 7/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
General disorders Peripheral swelling	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.6% 4/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Bronchitis	1.3% 2/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 5/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Influenza	3.2% 5/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.64% 1/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Nasopharyngitis	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Sinusitis	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	4.5% 7/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Upper respiratory tract infection	1.3% 2/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	4.5% 7/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	6.5% 10/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	6.4% 10/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Infections and infestations Urinary tract infection	1.9% 3/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	5.2% 8/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	4.5% 7/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Injury, poisoning and procedural complications Fall	1.3% 2/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 5/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Injury, poisoning and procedural complications Muscle strain	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Investigations Blood creatine phosphokinase increased	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 5/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Investigations Liver function test abnormal	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 5/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 5/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	5.8% 9/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.6% 4/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	5.7% 9/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Back pain	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.9% 6/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 5/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Muscle spasms	1.9% 3/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.5% 4/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Osteoarthritis	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.9% 6/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.6% 4/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	6.4% 10/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Carpal tunnel syndrome	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.8% 6/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Headache	4.5% 7/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	5.2% 8/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.2% 5/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Hypoaesthesia	1.9% 3/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	3.9% 6/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.9% 3/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Psychiatric disorders Depression	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.65% 1/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Respiratory, thoracic and mediastinal disorders Cough	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	0.00% 0/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Vascular disorders Hypertension	1.3% 2/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.6% 4/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	1.3% 2/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
Nervous system disorders Paraesthesia	3.9% 6/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	5.2% 8/155 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	2.6% 4/154 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492	5.1% 8/157 Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492