Trial Outcomes & Findings for Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip (NCT NCT00809354)

Last Updated: 2021-06-24

Results Overview

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) 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 was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2720 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2021-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Tanezumab 5 mg (Naproxen Exposure) Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Overall Study STARTED	288	289	286	288	288	256	255	257	256	257
Overall Study Treated	285	288	280	288	283	256	254	256	254	256
Overall Study COMPLETED	33	31	32	32	32	31	32	19	28	31
Overall Study NOT COMPLETED	255	258	254	256	256	225	223	238	228	226

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanezumab 5 mg (Naproxen Exposure) Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Overall Study Adverse Event	32	45	37	53	26	33	44	40	46	26
Overall Study Lack of Efficacy	23	23	22	15	40	19	21	15	18	38
Overall Study Lost to Follow-up	10	11	8	13	6	2	0	5	4	0
Overall Study Protocol Violation	7	14	14	12	14	6	4	6	9	3
Overall Study Withdrawal by Subject	32	27	31	33	34	29	27	19	18	20
Overall Study Other	10	2	7	10	5	3	2	3	4	3
Overall Study Study terminated by sponsor	138	134	129	120	126	133	124	148	127	135
Overall Study Withdrawn due to pregnancy	0	1	0	0	0	0	0	0	0	0
Overall Study Randomized but not Treated	3	1	6	0	5	0	1	1	2	1
Overall Study Death	0	0	0	0	0	0	0	1	0	0

Baseline Characteristics

Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.	Total n=2700 Participants Total of all reporting groups
Age, Customized 18 to 44 years	20 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	14 Participants n=21 Participants	8 Participants n=8 Participants	3 Participants n=8 Participants	11 Participants n=24 Participants	7 Participants n=42 Participants	3 Participants n=42 Participants	118 Participants n=42 Participants
Age, Customized 45 to 64 years	168 Participants n=5 Participants	181 Participants n=7 Participants	157 Participants n=5 Participants	171 Participants n=4 Participants	195 Participants n=21 Participants	134 Participants n=8 Participants	117 Participants n=8 Participants	139 Participants n=24 Participants	133 Participants n=42 Participants	144 Participants n=42 Participants	1539 Participants n=42 Participants
Age, Customized greater than or equal to (>=) 65 years	97 Participants n=5 Participants	91 Participants n=7 Participants	105 Participants n=5 Participants	99 Participants n=4 Participants	74 Participants n=21 Participants	114 Participants n=8 Participants	134 Participants n=8 Participants	106 Participants n=24 Participants	114 Participants n=42 Participants	109 Participants n=42 Participants	1043 Participants n=42 Participants
Sex: Female, Male Female	200 Participants n=5 Participants	208 Participants n=7 Participants	184 Participants n=5 Participants	192 Participants n=4 Participants	199 Participants n=21 Participants	192 Participants n=8 Participants	184 Participants n=8 Participants	179 Participants n=24 Participants	177 Participants n=42 Participants	189 Participants n=42 Participants	1904 Participants n=42 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	80 Participants n=7 Participants	96 Participants n=5 Participants	96 Participants n=4 Participants	84 Participants n=21 Participants	64 Participants n=8 Participants	70 Participants n=8 Participants	77 Participants n=24 Participants	77 Participants n=42 Participants	67 Participants n=42 Participants	796 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using baseline observation carried forward (BOCF). Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 Baseline	6.39 units on a scale Standard Deviation 1.61	6.50 units on a scale Standard Deviation 1.57	6.52 units on a scale Standard Deviation 1.65	6.33 units on a scale Standard Deviation 1.65	6.32 units on a scale Standard Deviation 1.64	6.49 units on a scale Standard Deviation 1.55	6.44 units on a scale Standard Deviation 1.53	6.41 units on a scale Standard Deviation 1.66	6.27 units on a scale Standard Deviation 1.64	6.29 units on a scale Standard Deviation 1.60
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 Change at Week 16	-1.80 units on a scale Standard Deviation 2.20	-1.97 units on a scale Standard Deviation 2.35	-2.09 units on a scale Standard Deviation 2.19	-2.26 units on a scale Standard Deviation 2.31	-1.34 units on a scale Standard Deviation 2.08	-2.11 units on a scale Standard Deviation 2.51	-2.12 units on a scale Standard Deviation 2.36	-2.28 units on a scale Standard Deviation 2.43	-2.41 units on a scale Standard Deviation 2.54	-1.48 units on a scale Standard Deviation 2.07

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=284 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=253 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=253 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=254 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 Baseline	6.46 units on a scale Standard Deviation 1.72	6.47 units on a scale Standard Deviation 1.61	6.57 units on a scale Standard Deviation 1.67	6.39 units on a scale Standard Deviation 1.62	6.32 units on a scale Standard Deviation 1.62	6.67 units on a scale Standard Deviation 1.60	6.58 units on a scale Standard Deviation 1.58	6.57 units on a scale Standard Deviation 1.72	6.39 units on a scale Standard Deviation 1.62	6.47 units on a scale Standard Deviation 1.59
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 Change at Week 16	-1.80 units on a scale Standard Deviation 2.15	-1.84 units on a scale Standard Deviation 2.13	-2.12 units on a scale Standard Deviation 2.19	-2.18 units on a scale Standard Deviation 2.31	-1.28 units on a scale Standard Deviation 1.96	-2.13 units on a scale Standard Deviation 2.34	-2.09 units on a scale Standard Deviation 2.34	-2.27 units on a scale Standard Deviation 2.40	-2.41 units on a scale Standard Deviation 2.43	-1.42 units on a scale Standard Deviation 2.03

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using baseline BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=284 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=285 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=253 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=254 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 Baseline	3.39 units on a scale Standard Deviation 0.63	3.41 units on a scale Standard Deviation 0.62	3.39 units on a scale Standard Deviation 0.63	3.39 units on a scale Standard Deviation 0.66	3.38 units on a scale Standard Deviation 0.63	3.44 units on a scale Standard Deviation 0.65	3.48 units on a scale Standard Deviation 0.63	3.45 units on a scale Standard Deviation 0.67	3.41 units on a scale Standard Deviation 0.64	3.37 units on a scale Standard Deviation 0.59
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 Change at Week 16	-0.54 units on a scale Standard Deviation 0.90	-0.63 units on a scale Standard Deviation 0.91	-0.61 units on a scale Standard Deviation 0.89	-0.72 units on a scale Standard Deviation 1.01	-0.53 units on a scale Standard Deviation 0.75	-0.69 units on a scale Standard Deviation 0.86	-0.64 units on a scale Standard Deviation 0.86	-0.76 units on a scale Standard Deviation 0.95	-0.75 units on a scale Standard Deviation 0.90	-0.51 units on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-0.96 units on a scale Standard Deviation 1.98	-1.00 units on a scale Standard Deviation 2.08	-1.27 units on a scale Standard Deviation 2.03	-0.89 units on a scale Standard Deviation 2.21	-0.90 units on a scale Standard Deviation 1.81	-1.01 units on a scale Standard Deviation 2.15	-0.74 units on a scale Standard Deviation 2.08	-1.08 units on a scale Standard Deviation 2.03	-0.86 units on a scale Standard Deviation 2.22	-0.93 units on a scale Standard Deviation 1.66
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.68 units on a scale Standard Deviation 2.05	-1.87 units on a scale Standard Deviation 1.96	-2.09 units on a scale Standard Deviation 2.13	-1.98 units on a scale Standard Deviation 2.22	-1.14 units on a scale Standard Deviation 2.09	-1.69 units on a scale Standard Deviation 2.39	-1.78 units on a scale Standard Deviation 2.06	-2.07 units on a scale Standard Deviation 2.27	-2.03 units on a scale Standard Deviation 2.27	-1.09 units on a scale Standard Deviation 1.94
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.68 units on a scale Standard Deviation 2.27	-2.08 units on a scale Standard Deviation 2.14	-2.10 units on a scale Standard Deviation 2.25	-2.18 units on a scale Standard Deviation 2.26	-1.13 units on a scale Standard Deviation 2.08	-1.83 units on a scale Standard Deviation 2.35	-2.01 units on a scale Standard Deviation 2.26	-2.23 units on a scale Standard Deviation 2.22	-2.36 units on a scale Standard Deviation 2.34	-1.15 units on a scale Standard Deviation 2.03
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.86 units on a scale Standard Deviation 2.32	-1.95 units on a scale Standard Deviation 2.21	-2.26 units on a scale Standard Deviation 2.21	-2.34 units on a scale Standard Deviation 2.35	-1.23 units on a scale Standard Deviation 2.12	-2.15 units on a scale Standard Deviation 2.44	-2.20 units on a scale Standard Deviation 2.54	-2.28 units on a scale Standard Deviation 2.39	-2.47 units on a scale Standard Deviation 2.40	-1.40 units on a scale Standard Deviation 1.96
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.65 units on a scale Standard Deviation 2.33	-1.82 units on a scale Standard Deviation 2.32	-1.83 units on a scale Standard Deviation 2.19	-1.95 units on a scale Standard Deviation 2.38	-1.32 units on a scale Standard Deviation 2.15	-1.81 units on a scale Standard Deviation 2.46	-2.04 units on a scale Standard Deviation 2.33	-2.10 units on a scale Standard Deviation 2.47	-2.29 units on a scale Standard Deviation 2.56	-1.63 units on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 2	-0.96 units on a scale Standard Deviation 1.98	-1.00 units on a scale Standard Deviation 2.08	-1.27 units on a scale Standard Deviation 2.03	-0.89 units on a scale Standard Deviation 2.21	-0.90 units on a scale Standard Deviation 1.81	-1.01 units on a scale Standard Deviation 2.15	-0.74 units on a scale Standard Deviation 2.08	-1.08 units on a scale Standard Deviation 2.03	-0.86 units on a scale Standard Deviation 2.22	-0.93 units on a scale Standard Deviation 1.66
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 4	-1.66 units on a scale Standard Deviation 2.09	-1.92 units on a scale Standard Deviation 1.96	-2.12 units on a scale Standard Deviation 2.13	-2.05 units on a scale Standard Deviation 2.24	-1.15 units on a scale Standard Deviation 2.12	-1.76 units on a scale Standard Deviation 2.45	-1.73 units on a scale Standard Deviation 2.13	-2.04 units on a scale Standard Deviation 2.35	-2.00 units on a scale Standard Deviation 2.31	-1.10 units on a scale Standard Deviation 1.94
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 8	-1.76 units on a scale Standard Deviation 2.34	-2.20 units on a scale Standard Deviation 2.17	-2.26 units on a scale Standard Deviation 2.25	-2.36 units on a scale Standard Deviation 2.25	-1.17 units on a scale Standard Deviation 2.16	-1.92 units on a scale Standard Deviation 2.45	-2.07 units on a scale Standard Deviation 2.32	-2.22 units on a scale Standard Deviation 2.34	-2.34 units on a scale Standard Deviation 2.42	-1.17 units on a scale Standard Deviation 2.06
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 12	-2.04 units on a scale Standard Deviation 2.40	-2.14 units on a scale Standard Deviation 2.24	-2.45 units on a scale Standard Deviation 2.18	-2.56 units on a scale Standard Deviation 2.35	-1.32 units on a scale Standard Deviation 2.26	-2.29 units on a scale Standard Deviation 2.53	-2.32 units on a scale Standard Deviation 2.63	-2.32 units on a scale Standard Deviation 2.50	-2.51 units on a scale Standard Deviation 2.47	-1.40 units on a scale Standard Deviation 2.05
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 16	-2.00 units on a scale Standard Deviation 2.29	-2.19 units on a scale Standard Deviation 2.37	-2.36 units on a scale Standard Deviation 2.20	-2.56 units on a scale Standard Deviation 2.27	-1.44 units on a scale Standard Deviation 2.22	-2.27 units on a scale Standard Deviation 2.59	-2.23 units on a scale Standard Deviation 2.46	-2.34 units on a scale Standard Deviation 2.54	-2.46 units on a scale Standard Deviation 2.59	-1.50 units on a scale Standard Deviation 2.17
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 24	-2.04 units on a scale Standard Deviation 2.44	-2.12 units on a scale Standard Deviation 2.37	-2.20 units on a scale Standard Deviation 2.26	-2.33 units on a scale Standard Deviation 2.39	-1.54 units on a scale Standard Deviation 2.38	-2.05 units on a scale Standard Deviation 2.56	-2.25 units on a scale Standard Deviation 2.44	-2.21 units on a scale Standard Deviation 2.59	-2.39 units on a scale Standard Deviation 2.64	-1.69 units on a scale Standard Deviation 2.23
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 32	-1.94 units on a scale Standard Deviation 2.51	-2.08 units on a scale Standard Deviation 2.40	-2.10 units on a scale Standard Deviation 2.32	-2.33 units on a scale Standard Deviation 2.42	-1.62 units on a scale Standard Deviation 2.38	-2.02 units on a scale Standard Deviation 2.57	-2.14 units on a scale Standard Deviation 2.58	-2.20 units on a scale Standard Deviation 2.61	-2.14 units on a scale Standard Deviation 2.67	-1.62 units on a scale Standard Deviation 2.24
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 40	-1.90 units on a scale Standard Deviation 2.54	-1.94 units on a scale Standard Deviation 2.50	-1.88 units on a scale Standard Deviation 2.38	-2.12 units on a scale Standard Deviation 2.39	-1.44 units on a scale Standard Deviation 2.38	-1.98 units on a scale Standard Deviation 2.49	-1.99 units on a scale Standard Deviation 2.52	-1.98 units on a scale Standard Deviation 2.62	-2.18 units on a scale Standard Deviation 2.60	-1.54 units on a scale Standard Deviation 2.22
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 48	-1.86 units on a scale Standard Deviation 2.54	-1.93 units on a scale Standard Deviation 2.51	-1.86 units on a scale Standard Deviation 2.44	-2.08 units on a scale Standard Deviation 2.34	-1.40 units on a scale Standard Deviation 2.38	-1.86 units on a scale Standard Deviation 2.47	-1.93 units on a scale Standard Deviation 2.51	-2.05 units on a scale Standard Deviation 2.58	-2.03 units on a scale Standard Deviation 2.63	-1.45 units on a scale Standard Deviation 2.25
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 56	-1.84 units on a scale Standard Deviation 2.54	-1.86 units on a scale Standard Deviation 2.49	-1.84 units on a scale Standard Deviation 2.44	-2.03 units on a scale Standard Deviation 2.32	-1.36 units on a scale Standard Deviation 2.34	-1.83 units on a scale Standard Deviation 2.38	-1.72 units on a scale Standard Deviation 2.47	-1.92 units on a scale Standard Deviation 2.55	-2.02 units on a scale Standard Deviation 2.61	-1.48 units on a scale Standard Deviation 2.27

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=253 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=253 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=254 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.10 units on a scale Standard Deviation 1.88	-1.13 units on a scale Standard Deviation 1.90	-1.44 units on a scale Standard Deviation 2.02	-1.06 units on a scale Standard Deviation 2.07	-0.90 units on a scale Standard Deviation 1.69	-1.18 units on a scale Standard Deviation 2.01	-0.95 units on a scale Standard Deviation 1.99	-1.21 units on a scale Standard Deviation 1.96	-1.02 units on a scale Standard Deviation 2.13	-0.90 units on a scale Standard Deviation 1.67
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.71 units on a scale Standard Deviation 2.00	-1.79 units on a scale Standard Deviation 1.88	-2.04 units on a scale Standard Deviation 2.16	-2.00 units on a scale Standard Deviation 2.06	-1.01 units on a scale Standard Deviation 1.90	-1.73 units on a scale Standard Deviation 2.23	-1.78 units on a scale Standard Deviation 2.06	-1.97 units on a scale Standard Deviation 2.19	-2.00 units on a scale Standard Deviation 2.13	-1.07 units on a scale Standard Deviation 1.83
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.62 units on a scale Standard Deviation 2.19	-2.01 units on a scale Standard Deviation 2.04	-2.05 units on a scale Standard Deviation 2.26	-2.15 units on a scale Standard Deviation 2.19	-1.07 units on a scale Standard Deviation 1.87	-1.89 units on a scale Standard Deviation 2.27	-2.00 units on a scale Standard Deviation 2.17	-2.15 units on a scale Standard Deviation 2.19	-2.30 units on a scale Standard Deviation 2.22	-1.13 units on a scale Standard Deviation 1.94
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.85 units on a scale Standard Deviation 2.25	-1.87 units on a scale Standard Deviation 2.06	-2.18 units on a scale Standard Deviation 2.17	-2.29 units on a scale Standard Deviation 2.33	-1.23 units on a scale Standard Deviation 2.00	-2.23 units on a scale Standard Deviation 2.34	-2.13 units on a scale Standard Deviation 2.43	-2.34 units on a scale Standard Deviation 2.36	-2.46 units on a scale Standard Deviation 2.32	-1.36 units on a scale Standard Deviation 1.97
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.66 units on a scale Standard Deviation 2.28	-1.76 units on a scale Standard Deviation 2.16	-1.76 units on a scale Standard Deviation 2.11	-1.96 units on a scale Standard Deviation 2.37	-1.30 units on a scale Standard Deviation 2.03	-1.92 units on a scale Standard Deviation 2.29	-2.00 units on a scale Standard Deviation 2.31	-2.08 units on a scale Standard Deviation 2.37	-2.33 units on a scale Standard Deviation 2.45	-1.57 units on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=284 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=253 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=253 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=254 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Baseline	6.46 units on a scale Standard Deviation 1.72	6.47 units on a scale Standard Deviation 1.61	6.57 units on a scale Standard Deviation 1.67	6.39 units on a scale Standard Deviation 1.62	6.32 units on a scale Standard Deviation 1.62	6.67 units on a scale Standard Deviation 1.60	6.58 units on a scale Standard Deviation 1.58	6.57 units on a scale Standard Deviation 1.72	6.39 units on a scale Standard Deviation 1.62	6.47 units on a scale Standard Deviation 1.59
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 2	-1.10 units on a scale Standard Deviation 1.88	-1.13 units on a scale Standard Deviation 1.90	-1.44 units on a scale Standard Deviation 2.02	-1.06 units on a scale Standard Deviation 2.07	-0.90 units on a scale Standard Deviation 1.69	-1.18 units on a scale Standard Deviation 2.01	-0.95 units on a scale Standard Deviation 1.99	-1.21 units on a scale Standard Deviation 1.96	-1.02 units on a scale Standard Deviation 2.13	-0.90 units on a scale Standard Deviation 1.67
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 4	-1.70 units on a scale Standard Deviation 2.02	-1.84 units on a scale Standard Deviation 1.87	-2.08 units on a scale Standard Deviation 2.15	-2.06 units on a scale Standard Deviation 2.11	-1.04 units on a scale Standard Deviation 1.91	-1.81 units on a scale Standard Deviation 2.30	-1.75 units on a scale Standard Deviation 2.10	-1.95 units on a scale Standard Deviation 2.24	-1.91 units on a scale Standard Deviation 2.18	-1.09 units on a scale Standard Deviation 1.83
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 8	-1.69 units on a scale Standard Deviation 2.23	-2.13 units on a scale Standard Deviation 2.06	-2.23 units on a scale Standard Deviation 2.26	-2.33 units on a scale Standard Deviation 2.21	-1.11 units on a scale Standard Deviation 1.95	-2.02 units on a scale Standard Deviation 2.37	-2.08 units on a scale Standard Deviation 2.19	-2.13 units on a scale Standard Deviation 2.29	-2.29 units on a scale Standard Deviation 2.30	-1.14 units on a scale Standard Deviation 1.96
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 12	-2.02 units on a scale Standard Deviation 2.31	-2.08 units on a scale Standard Deviation 2.12	-2.40 units on a scale Standard Deviation 2.15	-2.50 units on a scale Standard Deviation 2.36	-1.31 units on a scale Standard Deviation 2.11	-2.35 units on a scale Standard Deviation 2.48	-2.31 units on a scale Standard Deviation 2.46	-2.37 units on a scale Standard Deviation 2.44	-2.50 units on a scale Standard Deviation 2.42	-1.36 units on a scale Standard Deviation 2.05
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 24	-2.04 units on a scale Standard Deviation 2.37	-2.08 units on a scale Standard Deviation 2.22	-2.22 units on a scale Standard Deviation 2.21	-2.29 units on a scale Standard Deviation 2.46	-1.49 units on a scale Standard Deviation 2.22	-2.14 units on a scale Standard Deviation 2.42	-2.24 units on a scale Standard Deviation 2.31	-2.20 units on a scale Standard Deviation 2.45	-2.44 units on a scale Standard Deviation 2.54	-1.62 units on a scale Standard Deviation 2.22
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 32	-1.87 units on a scale Standard Deviation 2.40	-2.01 units on a scale Standard Deviation 2.29	-2.15 units on a scale Standard Deviation 2.32	-2.25 units on a scale Standard Deviation 2.46	-1.53 units on a scale Standard Deviation 2.29	-2.08 units on a scale Standard Deviation 2.47	-2.16 units on a scale Standard Deviation 2.42	-2.22 units on a scale Standard Deviation 2.56	-2.20 units on a scale Standard Deviation 2.62	-1.57 units on a scale Standard Deviation 2.23
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 40	-1.87 units on a scale Standard Deviation 2.37	-1.90 units on a scale Standard Deviation 2.40	-1.95 units on a scale Standard Deviation 2.34	-2.04 units on a scale Standard Deviation 2.48	-1.44 units on a scale Standard Deviation 2.23	-2.06 units on a scale Standard Deviation 2.48	-2.04 units on a scale Standard Deviation 2.40	-2.00 units on a scale Standard Deviation 2.59	-2.18 units on a scale Standard Deviation 2.60	-1.52 units on a scale Standard Deviation 2.24
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 48	-1.82 units on a scale Standard Deviation 2.36	-1.93 units on a scale Standard Deviation 2.43	-1.90 units on a scale Standard Deviation 2.41	-1.96 units on a scale Standard Deviation 2.39	-1.39 units on a scale Standard Deviation 2.25	-1.94 units on a scale Standard Deviation 2.44	-1.97 units on a scale Standard Deviation 2.42	-2.03 units on a scale Standard Deviation 2.56	-2.05 units on a scale Standard Deviation 2.58	-1.44 units on a scale Standard Deviation 2.23
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 56	-1.82 units on a scale Standard Deviation 2.36	-1.84 units on a scale Standard Deviation 2.41	-1.88 units on a scale Standard Deviation 2.41	-1.87 units on a scale Standard Deviation 2.38	-1.34 units on a scale Standard Deviation 2.22	-1.90 units on a scale Standard Deviation 2.36	-1.78 units on a scale Standard Deviation 2.36	-1.92 units on a scale Standard Deviation 2.54	-2.05 units on a scale Standard Deviation 2.57	-1.45 units on a scale Standard Deviation 2.24

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

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

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=284 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=285 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=253 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=254 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-0.45 units on a scale Standard Deviation 0.80	-0.42 units on a scale Standard Deviation 0.83	-0.50 units on a scale Standard Deviation 0.81	-0.40 units on a scale Standard Deviation 0.92	-0.39 units on a scale Standard Deviation 0.71	-0.46 units on a scale Standard Deviation 0.89	-0.33 units on a scale Standard Deviation 0.88	-0.45 units on a scale Standard Deviation 0.89	-0.26 units on a scale Standard Deviation 0.85	-0.37 units on a scale Standard Deviation 0.75
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-0.60 units on a scale Standard Deviation 0.78	-0.69 units on a scale Standard Deviation 0.81	-0.74 units on a scale Standard Deviation 0.86	-0.68 units on a scale Standard Deviation 0.87	-0.43 units on a scale Standard Deviation 0.80	-0.68 units on a scale Standard Deviation 0.88	-0.75 units on a scale Standard Deviation 0.92	-0.80 units on a scale Standard Deviation 0.92	-0.75 units on a scale Standard Deviation 0.84	-0.49 units on a scale Standard Deviation 0.85
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-0.58 units on a scale Standard Deviation 0.89	-0.70 units on a scale Standard Deviation 0.84	-0.69 units on a scale Standard Deviation 0.87	-0.82 units on a scale Standard Deviation 0.90	-0.45 units on a scale Standard Deviation 0.81	-0.63 units on a scale Standard Deviation 0.89	-0.69 units on a scale Standard Deviation 0.85	-0.81 units on a scale Standard Deviation 0.92	-0.79 units on a scale Standard Deviation 0.82	-0.51 units on a scale Standard Deviation 0.87
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-0.60 units on a scale Standard Deviation 0.89	-0.68 units on a scale Standard Deviation 0.85	-0.69 units on a scale Standard Deviation 0.88	-0.84 units on a scale Standard Deviation 0.99	-0.46 units on a scale Standard Deviation 0.89	-0.71 units on a scale Standard Deviation 0.86	-0.75 units on a scale Standard Deviation 0.88	-0.77 units on a scale Standard Deviation 0.93	-0.83 units on a scale Standard Deviation 0.89	-0.54 units on a scale Standard Deviation 0.83
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-0.58 units on a scale Standard Deviation 0.97	-0.54 units on a scale Standard Deviation 0.93	-0.50 units on a scale Standard Deviation 0.82	-0.60 units on a scale Standard Deviation 0.99	-0.49 units on a scale Standard Deviation 0.82	-0.57 units on a scale Standard Deviation 0.89	-0.59 units on a scale Standard Deviation 0.82	-0.67 units on a scale Standard Deviation 0.99	-0.74 units on a scale Standard Deviation 0.90	-0.55 units on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=284 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=285 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=253 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=254 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 40	-0.58 units on a scale Standard Deviation 0.98	-0.60 units on a scale Standard Deviation 0.98	-0.53 units on a scale Standard Deviation 0.93	-0.56 units on a scale Standard Deviation 1.10	-0.50 units on a scale Standard Deviation 0.91	-0.61 units on a scale Standard Deviation 1.03	-0.67 units on a scale Standard Deviation 0.87	-0.59 units on a scale Standard Deviation 1.00	-0.66 units on a scale Standard Deviation 1.01	-0.57 units on a scale Standard Deviation 0.94
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 48	-0.53 units on a scale Standard Deviation 0.99	-0.60 units on a scale Standard Deviation 0.98	-0.51 units on a scale Standard Deviation 0.92	-0.48 units on a scale Standard Deviation 1.09	-0.49 units on a scale Standard Deviation 0.91	-0.53 units on a scale Standard Deviation 1.04	-0.62 units on a scale Standard Deviation 0.91	-0.63 units on a scale Standard Deviation 0.98	-0.59 units on a scale Standard Deviation 1.01	-0.54 units on a scale Standard Deviation 0.95
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 56	-0.53 units on a scale Standard Deviation 1.00	-0.55 units on a scale Standard Deviation 0.95	-0.49 units on a scale Standard Deviation 0.94	-0.46 units on a scale Standard Deviation 1.09	-0.47 units on a scale Standard Deviation 0.89	-0.51 units on a scale Standard Deviation 1.01	-0.56 units on a scale Standard Deviation 0.85	-0.61 units on a scale Standard Deviation 1.00	-0.58 units on a scale Standard Deviation 1.02	-0.54 units on a scale Standard Deviation 0.96
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 2	-0.45 units on a scale Standard Deviation 0.80	-0.42 units on a scale Standard Deviation 0.83	-0.50 units on a scale Standard Deviation 0.81	-0.40 units on a scale Standard Deviation 0.92	-0.39 units on a scale Standard Deviation 0.71	-0.46 units on a scale Standard Deviation 0.89	-0.33 units on a scale Standard Deviation 0.88	-0.45 units on a scale Standard Deviation 0.89	-0.26 units on a scale Standard Deviation 0.85	-0.37 units on a scale Standard Deviation 0.75
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 4	-0.60 units on a scale Standard Deviation 0.80	-0.72 units on a scale Standard Deviation 0.82	-0.76 units on a scale Standard Deviation 0.86	-0.72 units on a scale Standard Deviation 0.90	-0.44 units on a scale Standard Deviation 0.80	-0.70 units on a scale Standard Deviation 0.91	-0.76 units on a scale Standard Deviation 0.93	-0.78 units on a scale Standard Deviation 0.95	-0.74 units on a scale Standard Deviation 0.86	-0.51 units on a scale Standard Deviation 0.85
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 8	-0.63 units on a scale Standard Deviation 0.91	-0.77 units on a scale Standard Deviation 0.87	-0.75 units on a scale Standard Deviation 0.88	-0.86 units on a scale Standard Deviation 0.95	-0.48 units on a scale Standard Deviation 0.83	-0.68 units on a scale Standard Deviation 0.91	-0.74 units on a scale Standard Deviation 0.87	-0.81 units on a scale Standard Deviation 0.94	-0.81 units on a scale Standard Deviation 0.85	-0.54 units on a scale Standard Deviation 0.90
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 12	-0.67 units on a scale Standard Deviation 0.91	-0.79 units on a scale Standard Deviation 0.89	-0.78 units on a scale Standard Deviation 0.90	-0.91 units on a scale Standard Deviation 1.04	-0.49 units on a scale Standard Deviation 0.93	-0.77 units on a scale Standard Deviation 0.90	-0.84 units on a scale Standard Deviation 0.89	-0.81 units on a scale Standard Deviation 0.95	-0.86 units on a scale Standard Deviation 0.93	-0.57 units on a scale Standard Deviation 0.88
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 16	-0.63 units on a scale Standard Deviation 0.93	-0.74 units on a scale Standard Deviation 0.95	-0.72 units on a scale Standard Deviation 0.92	-0.79 units on a scale Standard Deviation 1.07	-0.57 units on a scale Standard Deviation 0.81	-0.76 units on a scale Standard Deviation 0.91	-0.73 units on a scale Standard Deviation 0.88	-0.80 units on a scale Standard Deviation 0.96	-0.77 units on a scale Standard Deviation 0.94	-0.54 units on a scale Standard Deviation 0.92
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 24	-0.69 units on a scale Standard Deviation 1.02	-0.68 units on a scale Standard Deviation 1.00	-0.64 units on a scale Standard Deviation 0.87	-0.69 units on a scale Standard Deviation 1.07	-0.57 units on a scale Standard Deviation 0.89	-0.66 units on a scale Standard Deviation 0.96	-0.69 units on a scale Standard Deviation 0.87	-0.73 units on a scale Standard Deviation 1.02	-0.77 units on a scale Standard Deviation 0.96	-0.59 units on a scale Standard Deviation 0.93
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 32	-0.60 units on a scale Standard Deviation 0.97	-0.66 units on a scale Standard Deviation 0.95	-0.60 units on a scale Standard Deviation 0.93	-0.68 units on a scale Standard Deviation 1.16	-0.57 units on a scale Standard Deviation 0.96	-0.63 units on a scale Standard Deviation 1.02	-0.66 units on a scale Standard Deviation 0.92	-0.73 units on a scale Standard Deviation 0.91	-0.66 units on a scale Standard Deviation 1.00	-0.57 units on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, and 24

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

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was \>=20 percent and \>=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition).

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) Week 2	40.4 percentage of participants	35.5 percentage of participants	43.2 percentage of participants	36.1 percentage of participants	31.8 percentage of participants	39.6 percentage of participants	33.9 percentage of participants	39.5 percentage of participants	33.1 percentage of participants	32.4 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	53.0 percentage of participants	57.6 percentage of participants	60.7 percentage of participants	54.5 percentage of participants	39.7 percentage of participants	51.6 percentage of participants	55.5 percentage of participants	57.4 percentage of participants	57.5 percentage of participants	41.0 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) Week 8	49.5 percentage of participants	58.9 percentage of participants	60.4 percentage of participants	58.3 percentage of participants	39.0 percentage of participants	53.9 percentage of participants	57.5 percentage of participants	59.4 percentage of participants	65.0 percentage of participants	42.6 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	54.0 percentage of participants	56.1 percentage of participants	61.4 percentage of participants	61.1 percentage of participants	42.9 percentage of participants	56.6 percentage of participants	59.1 percentage of participants	62.1 percentage of participants	65.7 percentage of participants	45.3 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	52.3 percentage of participants	53.0 percentage of participants	56.8 percentage of participants	60.1 percentage of participants	45.2 percentage of participants	55.1 percentage of participants	55.9 percentage of participants	59.8 percentage of participants	63.4 percentage of participants	47.3 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	48.1 percentage of participants	50.9 percentage of participants	51.4 percentage of participants	51.0 percentage of participants	41.1 percentage of participants	49.8 percentage of participants	53.5 percentage of participants	54.7 percentage of participants	59.4 percentage of participants	49.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was \>=50 percent and \>=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was \>=20 percent and \>=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition).

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 2	40.4 percentage of participants	35.5 percentage of participants	43.2 percentage of participants	36.1 percentage of participants	31.8 percentage of participants	39.6 percentage of participants	33.9 percentage of participants	39.5 percentage of participants	33.1 percentage of participants	32.4 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 4	53.7 percentage of participants	59.0 percentage of participants	62.5 percentage of participants	57.6 percentage of participants	41.0 percentage of participants	53.1 percentage of participants	55.9 percentage of participants	57.8 percentage of participants	57.9 percentage of participants	41.8 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	53.3 percentage of participants	62.2 percentage of participants	65.7 percentage of participants	64.2 percentage of participants	41.0 percentage of participants	56.3 percentage of participants	61.4 percentage of participants	61.3 percentage of participants	66.5 percentage of participants	43.8 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	60.4 percentage of participants	61.8 percentage of participants	68.2 percentage of participants	68.4 percentage of participants	46.6 percentage of participants	60.9 percentage of participants	65.0 percentage of participants	65.6 percentage of participants	68.1 percentage of participants	47.7 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 16	59.3 percentage of participants	59.7 percentage of participants	65.7 percentage of participants	69.1 percentage of participants	49.5 percentage of participants	60.5 percentage of participants	62.2 percentage of participants	64.1 percentage of participants	66.5 percentage of participants	51.2 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	60.4 percentage of participants	60.1 percentage of participants	63.2 percentage of participants	62.2 percentage of participants	48.4 percentage of participants	58.6 percentage of participants	63.4 percentage of participants	60.5 percentage of participants	64.2 percentage of participants	55.1 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 32	60.7 percentage of participants	57.6 percentage of participants	61.4 percentage of participants	63.2 percentage of participants	52.3 percentage of participants	57.4 percentage of participants	56.3 percentage of participants	62.5 percentage of participants	60.6 percentage of participants	53.1 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 40	57.9 percentage of participants	56.3 percentage of participants	58.9 percentage of participants	59.0 percentage of participants	50.9 percentage of participants	58.2 percentage of participants	56.3 percentage of participants	57.4 percentage of participants	62.2 percentage of participants	49.2 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 48	58.2 percentage of participants	57.6 percentage of participants	57.9 percentage of participants	58.0 percentage of participants	49.5 percentage of participants	57.4 percentage of participants	55.9 percentage of participants	58.2 percentage of participants	58.3 percentage of participants	49.2 percentage of participants
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) Week 56	57.2 percentage of participants	54.9 percentage of participants	57.5 percentage of participants	58.0 percentage of participants	50.5 percentage of participants	56.6 percentage of participants	53.5 percentage of participants	57.0 percentage of participants	59.4 percentage of participants	49.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of \>=30%, \>=50%, \>=70%, or \>=90% in the WOMAC pain subscale scores from Baseline were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 2: >=30% Reduction	28.4 percentage of participants	26.8 percentage of participants	35.0 percentage of participants	24.9 percentage of participants	22.7 percentage of participants	28.0 percentage of participants	22.8 percentage of participants	30.6 percentage of participants	26.0 percentage of participants	24.7 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 2: >=50% Reduction	17.5 percentage of participants	17.1 percentage of participants	20.4 percentage of participants	16.1 percentage of participants	12.8 percentage of participants	12.6 percentage of participants	13.8 percentage of participants	17.3 percentage of participants	18.5 percentage of participants	11.0 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 2: >=70% Reduction	5.6 percentage of participants	8.7 percentage of participants	6.4 percentage of participants	7.4 percentage of participants	5.3 percentage of participants	7.1 percentage of participants	6.3 percentage of participants	7.8 percentage of participants	8.3 percentage of participants	5.5 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 2: >=90% Reduction	1.1 percentage of participants	1.4 percentage of participants	2.9 percentage of participants	1.8 percentage of participants	1.1 percentage of participants	2.4 percentage of participants	1.2 percentage of participants	1.2 percentage of participants	3.1 percentage of participants	1.6 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 4: >=30% Reduction	40.7 percentage of participants	45.6 percentage of participants	52.1 percentage of participants	47.7 percentage of participants	29.8 percentage of participants	39.8 percentage of participants	41.7 percentage of participants	49.0 percentage of participants	50.4 percentage of participants	31.0 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 4: >=50% Reduction	24.6 percentage of participants	30.0 percentage of participants	27.5 percentage of participants	32.3 percentage of participants	19.5 percentage of participants	22.4 percentage of participants	26.0 percentage of participants	30.2 percentage of participants	32.7 percentage of participants	18.4 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 4: >=70% Reduction	11.9 percentage of participants	12.5 percentage of participants	15.0 percentage of participants	17.5 percentage of participants	6.7 percentage of participants	13.8 percentage of participants	11.4 percentage of participants	16.5 percentage of participants	19.3 percentage of participants	7.1 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 4: >=90% Reduction	2.1 percentage of participants	3.1 percentage of participants	6.8 percentage of participants	4.2 percentage of participants	2.5 percentage of participants	4.3 percentage of participants	3.9 percentage of participants	6.3 percentage of participants	5.5 percentage of participants	1.0 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 8: >=30% Reduction	43.9 percentage of participants	49.8 percentage of participants	49.3 percentage of participants	49.8 percentage of participants	29.8 percentage of participants	44.1 percentage of participants	45.7 percentage of participants	51.0 percentage of participants	55.9 percentage of participants	30.2 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 8: >=50% Reduction	27.7 percentage of participants	33.8 percentage of participants	29.6 percentage of participants	35.1 percentage of participants	16.7 percentage of participants	27.2 percentage of participants	29.9 percentage of participants	33.7 percentage of participants	36.2 percentage of participants	18.8 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 8: >=70% Reduction	13.7 percentage of participants	16.4 percentage of participants	18.2 percentage of participants	21.1 percentage of participants	8.2 percentage of participants	13.8 percentage of participants	16.5 percentage of participants	18.8 percentage of participants	23.2 percentage of participants	9.0 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 8: >=90% Reduction	4.2 percentage of participants	3.8 percentage of participants	6.4 percentage of participants	7.7 percentage of participants	2.1 percentage of participants	5.1 percentage of participants	6.7 percentage of participants	6.3 percentage of participants	7.1 percentage of participants	2.7 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 12: >=30% Reduction	45.6 percentage of participants	46.3 percentage of participants	53.2 percentage of participants	54.4 percentage of participants	34.0 percentage of participants	48.0 percentage of participants	52.0 percentage of participants	53.7 percentage of participants	58.3 percentage of participants	36.5 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 12: >=50% Reduction	30.2 percentage of participants	32.8 percentage of participants	32.1 percentage of participants	39.3 percentage of participants	19.5 percentage of participants	33.5 percentage of participants	35.8 percentage of participants	37.6 percentage of participants	41.7 percentage of participants	21.6 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 12: >=70% Reduction	14.4 percentage of participants	16.0 percentage of participants	18.6 percentage of participants	23.9 percentage of participants	7.8 percentage of participants	19.3 percentage of participants	19.3 percentage of participants	20.8 percentage of participants	23.6 percentage of participants	9.0 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 12: >=90% Reduction	6.3 percentage of participants	6.3 percentage of participants	6.8 percentage of participants	9.8 percentage of participants	2.8 percentage of participants	4.7 percentage of participants	7.9 percentage of participants	7.1 percentage of participants	10.6 percentage of participants	2.4 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 16: >=30% Reduction	44.6 percentage of participants	47.0 percentage of participants	49.6 percentage of participants	54.0 percentage of participants	36.2 percentage of participants	48.0 percentage of participants	48.8 percentage of participants	52.9 percentage of participants	54.3 percentage of participants	39.2 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 16: >=50% Reduction	27.4 percentage of participants	32.8 percentage of participants	34.3 percentage of participants	36.5 percentage of participants	19.9 percentage of participants	35.0 percentage of participants	35.0 percentage of participants	37.6 percentage of participants	42.5 percentage of participants	24.3 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 16: >=70% Reduction	15.1 percentage of participants	17.4 percentage of participants	15.0 percentage of participants	24.9 percentage of participants	7.8 percentage of participants	20.1 percentage of participants	18.1 percentage of participants	22.0 percentage of participants	24.8 percentage of participants	9.8 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 16: >=90% Reduction	6.0 percentage of participants	6.3 percentage of participants	6.8 percentage of participants	8.4 percentage of participants	2.5 percentage of participants	7.5 percentage of participants	5.9 percentage of participants	7.8 percentage of participants	12.6 percentage of participants	2.7 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 24: >=30% Reduction	40.4 percentage of participants	44.9 percentage of participants	44.3 percentage of participants	46.0 percentage of participants	36.5 percentage of participants	42.5 percentage of participants	46.5 percentage of participants	47.1 percentage of participants	53.5 percentage of participants	41.6 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 24: >=50% Reduction	27.7 percentage of participants	31.7 percentage of participants	28.2 percentage of participants	34.4 percentage of participants	21.3 percentage of participants	30.3 percentage of participants	33.5 percentage of participants	35.3 percentage of participants	41.3 percentage of participants	25.9 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 24: >=70% Reduction	14.0 percentage of participants	17.4 percentage of participants	16.4 percentage of participants	21.4 percentage of participants	11.7 percentage of participants	15.4 percentage of participants	18.5 percentage of participants	21.6 percentage of participants	23.6 percentage of participants	11.4 percentage of participants
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF Week 24: >=90% Reduction	6.7 percentage of participants	7.3 percentage of participants	6.4 percentage of participants	6.0 percentage of participants	3.5 percentage of participants	7.5 percentage of participants	7.1 percentage of participants	7.5 percentage of participants	11.8 percentage of participants	3.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of \>=30 percent, \>=50%, \>=70%, or \>=90% in the WOMAC pain subscale scores from Baseline were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 2: >=30% Reduction	28.4 percentage of participants	26.8 percentage of participants	35.0 percentage of participants	24.9 percentage of participants	22.7 percentage of participants	28.0 percentage of participants	22.8 percentage of participants	30.6 percentage of participants	26.0 percentage of participants	24.7 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 2: >=50% Reduction	17.5 percentage of participants	17.1 percentage of participants	20.4 percentage of participants	16.1 percentage of participants	12.8 percentage of participants	12.6 percentage of participants	13.8 percentage of participants	17.3 percentage of participants	18.5 percentage of participants	11.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 2: >=70% Reduction	5.6 percentage of participants	8.7 percentage of participants	6.4 percentage of participants	7.4 percentage of participants	5.3 percentage of participants	7.1 percentage of participants	6.3 percentage of participants	7.8 percentage of participants	8.3 percentage of participants	5.5 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 2: >=90% Reduction	1.1 percentage of participants	1.4 percentage of participants	2.9 percentage of participants	1.8 percentage of participants	1.1 percentage of participants	2.4 percentage of participants	1.2 percentage of participants	1.2 percentage of participants	3.1 percentage of participants	1.6 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 4: >=30% Reduction	41.1 percentage of participants	46.3 percentage of participants	53.2 percentage of participants	49.8 percentage of participants	30.5 percentage of participants	41.3 percentage of participants	41.7 percentage of participants	49.8 percentage of participants	50.4 percentage of participants	31.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 4: >=50% Reduction	24.6 percentage of participants	30.7 percentage of participants	27.9 percentage of participants	33.7 percentage of participants	20.2 percentage of participants	23.6 percentage of participants	26.0 percentage of participants	30.6 percentage of participants	32.7 percentage of participants	18.4 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 4: >=70% Reduction	11.9 percentage of participants	12.5 percentage of participants	15.0 percentage of participants	17.9 percentage of participants	6.7 percentage of participants	14.2 percentage of participants	11.4 percentage of participants	16.9 percentage of participants	19.3 percentage of participants	7.1 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 4: >=90% Reduction	2.1 percentage of participants	3.1 percentage of participants	6.8 percentage of participants	4.6 percentage of participants	2.5 percentage of participants	4.7 percentage of participants	3.9 percentage of participants	6.3 percentage of participants	5.5 percentage of participants	1.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 8: >=30% Reduction	46.3 percentage of participants	51.9 percentage of participants	53.9 percentage of participants	55.1 percentage of participants	31.2 percentage of participants	46.5 percentage of participants	48.8 percentage of participants	52.9 percentage of participants	56.7 percentage of participants	31.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 8: >=50% Reduction	29.1 percentage of participants	35.2 percentage of participants	31.4 percentage of participants	38.9 percentage of participants	17.7 percentage of participants	28.7 percentage of participants	30.7 percentage of participants	34.5 percentage of participants	37.0 percentage of participants	18.8 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 8: >=70% Reduction	14.4 percentage of participants	16.7 percentage of participants	19.3 percentage of participants	22.8 percentage of participants	8.5 percentage of participants	14.6 percentage of participants	17.3 percentage of participants	19.2 percentage of participants	23.6 percentage of participants	9.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 8: >=90% Reduction	4.2 percentage of participants	4.2 percentage of participants	6.4 percentage of participants	8.4 percentage of participants	2.1 percentage of participants	5.9 percentage of participants	7.1 percentage of participants	6.3 percentage of participants	7.5 percentage of participants	2.7 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 12: >=30% Reduction	49.8 percentage of participants	50.9 percentage of participants	59.3 percentage of participants	60.7 percentage of participants	36.9 percentage of participants	52.8 percentage of participants	57.1 percentage of participants	57.3 percentage of participants	60.2 percentage of participants	37.6 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 12: >=50% Reduction	32.6 percentage of participants	35.5 percentage of participants	34.3 percentage of participants	43.5 percentage of participants	21.3 percentage of participants	36.6 percentage of participants	37.8 percentage of participants	39.2 percentage of participants	42.9 percentage of participants	22.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 12: >=70% Reduction	15.4 percentage of participants	16.4 percentage of participants	19.6 percentage of participants	26.0 percentage of participants	8.5 percentage of participants	20.5 percentage of participants	20.9 percentage of participants	21.6 percentage of participants	24.0 percentage of participants	9.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 12: >=90% Reduction	6.3 percentage of participants	6.6 percentage of participants	7.1 percentage of participants	10.5 percentage of participants	2.8 percentage of participants	5.1 percentage of participants	8.7 percentage of participants	7.1 percentage of participants	11.0 percentage of participants	2.4 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 16: >=30% Reduction	49.1 percentage of participants	52.3 percentage of participants	56.8 percentage of participants	61.8 percentage of participants	39.7 percentage of participants	52.4 percentage of participants	53.9 percentage of participants	56.9 percentage of participants	57.1 percentage of participants	41.6 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 16: >=50% Reduction	30.2 percentage of participants	35.9 percentage of participants	37.5 percentage of participants	41.8 percentage of participants	21.6 percentage of participants	38.2 percentage of participants	36.6 percentage of participants	39.2 percentage of participants	43.7 percentage of participants	25.5 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 16: >=70% Reduction	16.1 percentage of participants	18.1 percentage of participants	16.8 percentage of participants	27.4 percentage of participants	8.5 percentage of participants	20.9 percentage of participants	19.7 percentage of participants	22.7 percentage of participants	24.8 percentage of participants	9.8 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 16: >=90% Reduction	6.0 percentage of participants	6.6 percentage of participants	7.5 percentage of participants	9.1 percentage of participants	2.5 percentage of participants	7.9 percentage of participants	6.7 percentage of participants	7.8 percentage of participants	12.6 percentage of participants	2.7 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 24: >=30% Reduction	49.5 percentage of participants	53.0 percentage of participants	54.3 percentage of participants	55.8 percentage of participants	42.9 percentage of participants	49.2 percentage of participants	53.9 percentage of participants	52.5 percentage of participants	57.9 percentage of participants	45.5 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 24: >=50% Reduction	34.0 percentage of participants	36.2 percentage of participants	33.2 percentage of participants	40.7 percentage of participants	25.2 percentage of participants	34.3 percentage of participants	35.4 percentage of participants	37.6 percentage of participants	43.3 percentage of participants	27.8 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 24: >=70% Reduction	16.8 percentage of participants	18.5 percentage of participants	19.6 percentage of participants	24.6 percentage of participants	13.1 percentage of participants	16.5 percentage of participants	20.5 percentage of participants	22.7 percentage of participants	24.0 percentage of participants	11.4 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 24: >=90% Reduction	7.4 percentage of participants	7.7 percentage of participants	7.5 percentage of participants	7.4 percentage of participants	4.3 percentage of participants	7.9 percentage of participants	7.9 percentage of participants	7.8 percentage of participants	11.8 percentage of participants	3.9 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 32: >=30% Reduction	49.5 percentage of participants	52.3 percentage of participants	53.6 percentage of participants	56.5 percentage of participants	44.3 percentage of participants	49.6 percentage of participants	51.6 percentage of participants	52.5 percentage of participants	53.5 percentage of participants	43.1 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 32: >=50% Reduction	30.2 percentage of participants	33.8 percentage of participants	33.9 percentage of participants	42.5 percentage of participants	27.3 percentage of participants	35.4 percentage of participants	36.2 percentage of participants	39.2 percentage of participants	39.4 percentage of participants	28.2 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 32: >=70% Reduction	18.2 percentage of participants	17.8 percentage of participants	16.1 percentage of participants	22.1 percentage of participants	12.1 percentage of participants	19.3 percentage of participants	21.7 percentage of participants	21.6 percentage of participants	22.0 percentage of participants	12.5 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 32: >=90% Reduction	5.6 percentage of participants	7.0 percentage of participants	5.4 percentage of participants	8.4 percentage of participants	5.0 percentage of participants	7.9 percentage of participants	9.1 percentage of participants	10.6 percentage of participants	12.6 percentage of participants	2.4 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 40: >=30% Reduction	49.5 percentage of participants	50.9 percentage of participants	51.8 percentage of participants	52.6 percentage of participants	42.2 percentage of participants	49.2 percentage of participants	50.8 percentage of participants	49.8 percentage of participants	53.9 percentage of participants	41.6 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 40: >=50% Reduction	31.9 percentage of participants	31.7 percentage of participants	30.4 percentage of participants	38.2 percentage of participants	25.5 percentage of participants	34.3 percentage of participants	31.1 percentage of participants	33.3 percentage of participants	39.0 percentage of participants	29.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 40: >=70% Reduction	16.1 percentage of participants	17.4 percentage of participants	15.7 percentage of participants	19.3 percentage of participants	9.2 percentage of participants	17.7 percentage of participants	20.5 percentage of participants	19.6 percentage of participants	21.7 percentage of participants	11.4 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 40: >=90% Reduction	5.3 percentage of participants	5.6 percentage of participants	4.6 percentage of participants	5.6 percentage of participants	3.2 percentage of participants	7.5 percentage of participants	5.9 percentage of participants	8.6 percentage of participants	9.4 percentage of participants	2.4 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 48: >=30% Reduction	48.8 percentage of participants	51.6 percentage of participants	51.4 percentage of participants	51.9 percentage of participants	40.4 percentage of participants	48.4 percentage of participants	49.2 percentage of participants	50.2 percentage of participants	51.2 percentage of participants	42.0 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 48: >=50% Reduction	30.9 percentage of participants	30.7 percentage of participants	30.4 percentage of participants	36.5 percentage of participants	23.4 percentage of participants	30.7 percentage of participants	31.9 percentage of participants	33.7 percentage of participants	37.0 percentage of participants	27.1 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 48: >=70% Reduction	17.2 percentage of participants	16.0 percentage of participants	15.4 percentage of participants	18.9 percentage of participants	11.0 percentage of participants	16.1 percentage of participants	18.9 percentage of participants	20.4 percentage of participants	20.5 percentage of participants	11.8 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 48: >=90% Reduction	5.6 percentage of participants	5.9 percentage of participants	4.6 percentage of participants	6.7 percentage of participants	3.9 percentage of participants	5.9 percentage of participants	5.5 percentage of participants	7.5 percentage of participants	9.4 percentage of participants	2.7 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 56: >=30% Reduction	47.7 percentage of participants	50.2 percentage of participants	51.4 percentage of participants	52.6 percentage of participants	40.4 percentage of participants	46.9 percentage of participants	46.5 percentage of participants	47.8 percentage of participants	52.0 percentage of participants	41.6 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 56: >=50% Reduction	30.2 percentage of participants	28.9 percentage of participants	28.6 percentage of participants	36.1 percentage of participants	22.7 percentage of participants	29.9 percentage of participants	28.7 percentage of participants	31.8 percentage of participants	37.8 percentage of participants	27.5 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 56: >=70% Reduction	16.5 percentage of participants	15.3 percentage of participants	16.1 percentage of participants	17.9 percentage of participants	9.9 percentage of participants	14.2 percentage of participants	16.5 percentage of participants	18.4 percentage of participants	20.5 percentage of participants	12.5 percentage of participants
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) Week 56: >=90% Reduction	6.0 percentage of participants	5.2 percentage of participants	4.6 percentage of participants	6.3 percentage of participants	3.2 percentage of participants	5.1 percentage of participants	4.7 percentage of participants	7.5 percentage of participants	8.7 percentage of participants	2.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of \>0% to \>=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=285 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >0%	198 Participants	201 Participants	199 Participants	203 Participants	172 Participants	177 Participants	182 Participants	193 Participants	194 Participants	170 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >=10%	179 Participants	184 Participants	183 Participants	194 Participants	153 Participants	162 Participants	167 Participants	176 Participants	184 Participants	150 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >=20%	148 Participants	162 Participants	158 Participants	174 Participants	130 Participants	142 Participants	150 Participants	151 Participants	162 Participants	124 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >=30%	127 Participants	135 Participants	139 Participants	154 Participants	102 Participants	122 Participants	124 Participants	135 Participants	138 Participants	100 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >=40%	103 Participants	117 Participants	118 Participants	132 Participants	81 Participants	108 Participants	114 Participants	115 Participants	123 Participants	81 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >=50%	78 Participants	94 Participants	96 Participants	104 Participants	56 Participants	89 Participants	89 Participants	96 Participants	108 Participants	62 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >=60%	53 Participants	75 Participants	61 Participants	82 Participants	39 Participants	70 Participants	68 Participants	72 Participants	79 Participants	44 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >=70%	43 Participants	50 Participants	42 Participants	71 Participants	22 Participants	51 Participants	46 Participants	56 Participants	63 Participants	25 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >=80%	29 Participants	29 Participants	31 Participants	45 Participants	14 Participants	31 Participants	34 Participants	36 Participants	50 Participants	13 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) >=90%	17 Participants	18 Participants	19 Participants	24 Participants	7 Participants	19 Participants	15 Participants	20 Participants	32 Participants	7 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) 100%	4 Participants	11 Participants	12 Participants	10 Participants	3 Participants	5 Participants	8 Participants	7 Participants	11 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of \>0% to \>=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >=80%	31 Participants	30 Participants	36 Participants	48 Participants	16 Participants	32 Participants	38 Participants	37 Participants	50 Participants	13 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >=90%	17 Participants	19 Participants	21 Participants	26 Participants	7 Participants	20 Participants	17 Participants	20 Participants	32 Participants	7 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) 100%	4 Participants	12 Participants	14 Participants	12 Participants	3 Participants	5 Participants	8 Participants	7 Participants	11 Participants	5 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >0%	228 Participants	234 Participants	233 Participants	245 Participants	201 Participants	197 Participants	202 Participants	208 Participants	208 Participants	188 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >=10%	203 Participants	210 Participants	215 Participants	229 Participants	175 Participants	179 Participants	184 Participants	188 Participants	197 Participants	162 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >=20%	167 Participants	183 Participants	181 Participants	201 Participants	144 Participants	157 Participants	167 Participants	163 Participants	173 Participants	134 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >=30%	140 Participants	150 Participants	159 Participants	176 Participants	112 Participants	133 Participants	137 Participants	145 Participants	145 Participants	106 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >=40%	114 Participants	129 Participants	132 Participants	150 Participants	88 Participants	117 Participants	120 Participants	120 Participants	127 Participants	84 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >=50%	86 Participants	103 Participants	105 Participants	119 Participants	61 Participants	97 Participants	93 Participants	100 Participants	111 Participants	65 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >=60%	58 Participants	79 Participants	68 Participants	92 Participants	43 Participants	77 Participants	72 Participants	75 Participants	80 Participants	45 Participants
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) >=70%	46 Participants	52 Participants	47 Participants	78 Participants	24 Participants	53 Participants	50 Participants	58 Participants	63 Participants	25 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, and 24

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

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of \>=2 points on scale were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) Week 2	9.9 percentage of participants	10.1 percentage of participants	8.2 percentage of participants	10.9 percentage of participants	6.4 percentage of participants	11.3 percentage of participants	9.4 percentage of participants	12.5 percentage of participants	5.9 percentage of participants	6.3 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) Week 4	10.2 percentage of participants	13.5 percentage of participants	17.5 percentage of participants	15.1 percentage of participants	10.6 percentage of participants	19.1 percentage of participants	18.5 percentage of participants	18.8 percentage of participants	14.6 percentage of participants	10.6 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) Week 8	14.1 percentage of participants	18.4 percentage of participants	18.2 percentage of participants	19.3 percentage of participants	9.2 percentage of participants	15.6 percentage of participants	16.5 percentage of participants	19.6 percentage of participants	17.4 percentage of participants	11.8 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) Week 12	15.5 percentage of participants	17.4 percentage of participants	18.2 percentage of participants	25.3 percentage of participants	12.7 percentage of participants	17.2 percentage of participants	17.7 percentage of participants	20.8 percentage of participants	22.1 percentage of participants	12.2 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) Week 16	14.8 percentage of participants	19.1 percentage of participants	16.4 percentage of participants	22.5 percentage of participants	10.6 percentage of participants	18.4 percentage of participants	15.4 percentage of participants	20.0 percentage of participants	18.2 percentage of participants	13.4 percentage of participants
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) Week 24	17.6 percentage of participants	18.1 percentage of participants	12.1 percentage of participants	18.6 percentage of participants	14.1 percentage of participants	13.3 percentage of participants	12.6 percentage of participants	18.8 percentage of participants	20.9 percentage of participants	13.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of \>=2 points on scale were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 2	9.9 percentage of participants	10.1 percentage of participants	8.2 percentage of participants	10.9 percentage of participants	6.4 percentage of participants	11.3 percentage of participants	9.4 percentage of participants	12.5 percentage of participants	5.9 percentage of participants	6.3 percentage of participants
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 4	10.6 percentage of participants	14.2 percentage of participants	17.9 percentage of participants	16.1 percentage of participants	10.6 percentage of participants	20.3 percentage of participants	18.9 percentage of participants	18.8 percentage of participants	14.6 percentage of participants	11.0 percentage of participants
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 8	15.1 percentage of participants	20.5 percentage of participants	19.3 percentage of participants	20.7 percentage of participants	9.9 percentage of participants	17.2 percentage of participants	18.5 percentage of participants	19.6 percentage of participants	18.2 percentage of participants	13.0 percentage of participants
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 12	16.9 percentage of participants	20.8 percentage of participants	20.4 percentage of participants	27.0 percentage of participants	13.8 percentage of participants	19.1 percentage of participants	20.9 percentage of participants	21.6 percentage of participants	23.3 percentage of participants	13.4 percentage of participants
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 16	16.5 percentage of participants	22.6 percentage of participants	18.9 percentage of participants	24.2 percentage of participants	12.0 percentage of participants	21.1 percentage of participants	18.1 percentage of participants	20.8 percentage of participants	19.4 percentage of participants	14.6 percentage of participants
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 24	20.1 percentage of participants	22.2 percentage of participants	15.4 percentage of participants	21.4 percentage of participants	16.3 percentage of participants	16.8 percentage of participants	15.4 percentage of participants	20.4 percentage of participants	22.5 percentage of participants	15.0 percentage of participants
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 32	14.4 percentage of participants	18.8 percentage of participants	16.4 percentage of participants	23.2 percentage of participants	15.5 percentage of participants	19.1 percentage of participants	16.5 percentage of participants	19.2 percentage of participants	20.2 percentage of participants	15.0 percentage of participants
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 40	14.8 percentage of participants	17.4 percentage of participants	13.9 percentage of participants	18.9 percentage of participants	14.1 percentage of participants	18.4 percentage of participants	15.0 percentage of participants	18.4 percentage of participants	20.6 percentage of participants	15.4 percentage of participants
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 48	14.4 percentage of participants	16.7 percentage of participants	12.9 percentage of participants	16.1 percentage of participants	14.5 percentage of participants	17.2 percentage of participants	14.6 percentage of participants	18.8 percentage of participants	17.4 percentage of participants	14.6 percentage of participants
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) Week 56	14.4 percentage of participants	15.3 percentage of participants	13.6 percentage of participants	15.8 percentage of participants	13.4 percentage of participants	14.8 percentage of participants	11.8 percentage of participants	18.4 percentage of participants	17.8 percentage of participants	15.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=284 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=281 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Baseline	6.50 units on a scale Standard Deviation 2.00	6.66 units on a scale Standard Deviation 1.85	6.70 units on a scale Standard Deviation 1.88	6.42 units on a scale Standard Deviation 2.05	6.60 units on a scale Standard Deviation 1.73	6.62 units on a scale Standard Deviation 2.14	6.58 units on a scale Standard Deviation 2.04	6.47 units on a scale Standard Deviation 2.14	6.33 units on a scale Standard Deviation 2.01	6.39 units on a scale Standard Deviation 1.89
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.35 units on a scale Standard Deviation 2.43	-1.32 units on a scale Standard Deviation 2.18	-1.65 units on a scale Standard Deviation 2.44	-1.19 units on a scale Standard Deviation 2.29	-1.02 units on a scale Standard Deviation 1.98	-1.35 units on a scale Standard Deviation 2.52	-1.21 units on a scale Standard Deviation 2.40	-1.41 units on a scale Standard Deviation 2.31	-1.11 units on a scale Standard Deviation 2.44	-0.82 units on a scale Standard Deviation 2.04
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.85 units on a scale Standard Deviation 2.46	-2.10 units on a scale Standard Deviation 2.34	-2.31 units on a scale Standard Deviation 2.51	-2.19 units on a scale Standard Deviation 2.44	-1.23 units on a scale Standard Deviation 2.17	-1.94 units on a scale Standard Deviation 2.65	-2.05 units on a scale Standard Deviation 2.49	-2.15 units on a scale Standard Deviation 2.48	-2.25 units on a scale Standard Deviation 2.43	-1.00 units on a scale Standard Deviation 2.18
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.76 units on a scale Standard Deviation 2.60	-2.26 units on a scale Standard Deviation 2.38	-2.26 units on a scale Standard Deviation 2.66	-2.31 units on a scale Standard Deviation 2.54	-1.29 units on a scale Standard Deviation 2.24	-2.02 units on a scale Standard Deviation 2.66	-2.22 units on a scale Standard Deviation 2.59	-2.28 units on a scale Standard Deviation 2.51	-2.60 units on a scale Standard Deviation 2.51	-1.13 units on a scale Standard Deviation 2.16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.98 units on a scale Standard Deviation 2.64	-2.14 units on a scale Standard Deviation 2.38	-2.49 units on a scale Standard Deviation 2.52	-2.42 units on a scale Standard Deviation 2.69	-1.40 units on a scale Standard Deviation 2.27	-2.38 units on a scale Standard Deviation 2.75	-2.36 units on a scale Standard Deviation 2.87	-2.42 units on a scale Standard Deviation 2.70	-2.72 units on a scale Standard Deviation 2.54	-1.23 units on a scale Standard Deviation 2.16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.93 units on a scale Standard Deviation 2.55	-2.15 units on a scale Standard Deviation 2.40	-2.31 units on a scale Standard Deviation 2.57	-2.40 units on a scale Standard Deviation 2.65	-1.42 units on a scale Standard Deviation 2.22	-2.14 units on a scale Standard Deviation 2.74	-2.28 units on a scale Standard Deviation 2.68	-2.35 units on a scale Standard Deviation 2.62	-2.62 units on a scale Standard Deviation 2.64	-1.34 units on a scale Standard Deviation 2.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.80 units on a scale Standard Deviation 2.62	-1.96 units on a scale Standard Deviation 2.52	-1.98 units on a scale Standard Deviation 2.57	-2.04 units on a scale Standard Deviation 2.74	-1.46 units on a scale Standard Deviation 2.28	-1.97 units on a scale Standard Deviation 2.56	-2.10 units on a scale Standard Deviation 2.64	-2.08 units on a scale Standard Deviation 2.59	-2.39 units on a scale Standard Deviation 2.59	-1.38 units on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=284 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=281 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 2	-1.35 units on a scale Standard Deviation 2.43	-1.32 units on a scale Standard Deviation 2.18	-1.65 units on a scale Standard Deviation 2.44	-1.19 units on a scale Standard Deviation 2.29	-1.02 units on a scale Standard Deviation 1.98	-1.35 units on a scale Standard Deviation 2.52	-1.21 units on a scale Standard Deviation 2.40	-1.41 units on a scale Standard Deviation 2.31	-1.11 units on a scale Standard Deviation 2.44	-0.82 units on a scale Standard Deviation 2.04
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 4	-1.88 units on a scale Standard Deviation 2.49	-2.17 units on a scale Standard Deviation 2.33	-2.34 units on a scale Standard Deviation 2.50	-2.27 units on a scale Standard Deviation 2.46	-1.26 units on a scale Standard Deviation 2.20	-2.04 units on a scale Standard Deviation 2.71	-2.03 units on a scale Standard Deviation 2.52	-2.13 units on a scale Standard Deviation 2.53	-2.22 units on a scale Standard Deviation 2.49	-1.01 units on a scale Standard Deviation 2.18
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 8	-1.88 units on a scale Standard Deviation 2.67	-2.43 units on a scale Standard Deviation 2.38	-2.44 units on a scale Standard Deviation 2.66	-2.52 units on a scale Standard Deviation 2.53	-1.35 units on a scale Standard Deviation 2.32	-2.15 units on a scale Standard Deviation 2.75	-2.30 units on a scale Standard Deviation 2.62	-2.30 units on a scale Standard Deviation 2.62	-2.58 units on a scale Standard Deviation 2.60	-1.15 units on a scale Standard Deviation 2.18
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 12	-2.18 units on a scale Standard Deviation 2.71	-2.39 units on a scale Standard Deviation 2.38	-2.71 units on a scale Standard Deviation 2.50	-2.68 units on a scale Standard Deviation 2.69	-1.52 units on a scale Standard Deviation 2.40	-2.55 units on a scale Standard Deviation 2.92	-2.49 units on a scale Standard Deviation 2.90	-2.49 units on a scale Standard Deviation 2.79	-2.76 units on a scale Standard Deviation 2.64	-1.24 units on a scale Standard Deviation 2.23
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 16	-2.16 units on a scale Standard Deviation 2.62	-2.44 units on a scale Standard Deviation 2.38	-2.64 units on a scale Standard Deviation 2.58	-2.70 units on a scale Standard Deviation 2.67	-1.58 units on a scale Standard Deviation 2.35	-2.35 units on a scale Standard Deviation 2.91	-2.41 units on a scale Standard Deviation 2.71	-2.43 units on a scale Standard Deviation 2.77	-2.68 units on a scale Standard Deviation 2.72	-1.38 units on a scale Standard Deviation 2.25
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 24	-2.22 units on a scale Standard Deviation 2.75	-2.36 units on a scale Standard Deviation 2.50	-2.48 units on a scale Standard Deviation 2.65	-2.46 units on a scale Standard Deviation 2.81	-1.75 units on a scale Standard Deviation 2.45	-2.28 units on a scale Standard Deviation 2.78	-2.37 units on a scale Standard Deviation 2.66	-2.23 units on a scale Standard Deviation 2.78	-2.55 units on a scale Standard Deviation 2.68	-1.43 units on a scale Standard Deviation 2.33
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 32	-2.07 units on a scale Standard Deviation 2.86	-2.23 units on a scale Standard Deviation 2.51	-2.36 units on a scale Standard Deviation 2.62	-2.48 units on a scale Standard Deviation 2.80	-1.80 units on a scale Standard Deviation 2.52	-2.18 units on a scale Standard Deviation 2.79	-2.31 units on a scale Standard Deviation 2.73	-2.46 units on a scale Standard Deviation 2.79	-2.31 units on a scale Standard Deviation 2.68	-1.41 units on a scale Standard Deviation 2.37
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 40	-2.05 units on a scale Standard Deviation 2.85	-2.15 units on a scale Standard Deviation 2.63	-2.13 units on a scale Standard Deviation 2.63	-2.24 units on a scale Standard Deviation 2.76	-1.69 units on a scale Standard Deviation 2.52	-2.10 units on a scale Standard Deviation 2.83	-2.20 units on a scale Standard Deviation 2.74	-2.16 units on a scale Standard Deviation 2.74	-2.26 units on a scale Standard Deviation 2.68	-1.43 units on a scale Standard Deviation 2.47
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 48	-2.03 units on a scale Standard Deviation 2.90	-2.23 units on a scale Standard Deviation 2.71	-2.11 units on a scale Standard Deviation 2.71	-2.20 units on a scale Standard Deviation 2.71	-1.69 units on a scale Standard Deviation 2.54	-2.01 units on a scale Standard Deviation 2.80	-2.10 units on a scale Standard Deviation 2.73	-2.22 units on a scale Standard Deviation 2.80	-2.17 units on a scale Standard Deviation 2.67	-1.34 units on a scale Standard Deviation 2.45
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 56	-1.99 units on a scale Standard Deviation 2.86	-2.10 units on a scale Standard Deviation 2.66	-2.07 units on a scale Standard Deviation 2.72	-2.08 units on a scale Standard Deviation 2.74	-1.63 units on a scale Standard Deviation 2.49	-1.97 units on a scale Standard Deviation 2.80	-1.94 units on a scale Standard Deviation 2.72	-2.10 units on a scale Standard Deviation 2.76	-2.14 units on a scale Standard Deviation 2.69	-1.34 units on a scale Standard Deviation 2.47

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Baseline	6.45 units on a scale Standard Deviation 1.62	6.54 units on a scale Standard Deviation 1.53	6.60 units on a scale Standard Deviation 1.58	6.38 units on a scale Standard Deviation 1.63	6.41 units on a scale Standard Deviation 1.51	6.60 units on a scale Standard Deviation 1.58	6.54 units on a scale Standard Deviation 1.54	6.48 units on a scale Standard Deviation 1.70	6.33 units on a scale Standard Deviation 1.59	6.38 units on a scale Standard Deviation 1.55
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.13 units on a scale Standard Deviation 1.90	-1.15 units on a scale Standard Deviation 1.86	-1.46 units on a scale Standard Deviation 2.03	-1.04 units on a scale Standard Deviation 2.03	-0.93 units on a scale Standard Deviation 1.69	-1.17 units on a scale Standard Deviation 2.05	-0.98 units on a scale Standard Deviation 2.01	-1.23 units on a scale Standard Deviation 1.94	-0.99 units on a scale Standard Deviation 2.12	-0.89 units on a scale Standard Deviation 1.65
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.74 units on a scale Standard Deviation 2.04	-1.92 units on a scale Standard Deviation 1.91	-2.15 units on a scale Standard Deviation 2.15	-2.06 units on a scale Standard Deviation 2.11	-1.13 units on a scale Standard Deviation 1.91	-1.79 units on a scale Standard Deviation 2.30	-1.87 units on a scale Standard Deviation 2.07	-2.08 units on a scale Standard Deviation 2.20	-2.10 units on a scale Standard Deviation 2.17	-1.06 units on a scale Standard Deviation 1.85
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.68 units on a scale Standard Deviation 2.21	-2.11 units on a scale Standard Deviation 2.05	-2.14 units on a scale Standard Deviation 2.27	-2.22 units on a scale Standard Deviation 2.20	-1.15 units on a scale Standard Deviation 1.94	-1.93 units on a scale Standard Deviation 2.30	-2.08 units on a scale Standard Deviation 2.22	-2.23 units on a scale Standard Deviation 2.19	-2.42 units on a scale Standard Deviation 2.25	-1.14 units on a scale Standard Deviation 1.91
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.90 units on a scale Standard Deviation 2.26	-1.98 units on a scale Standard Deviation 2.08	-2.31 units on a scale Standard Deviation 2.18	-2.35 units on a scale Standard Deviation 2.33	-1.27 units on a scale Standard Deviation 2.02	-2.26 units on a scale Standard Deviation 2.40	-2.24 units on a scale Standard Deviation 2.52	-2.35 units on a scale Standard Deviation 2.36	-2.55 units on a scale Standard Deviation 2.30	-1.33 units on a scale Standard Deviation 1.89
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.84 units on a scale Standard Deviation 2.17	-1.98 units on a scale Standard Deviation 2.17	-2.17 units on a scale Standard Deviation 2.19	-2.28 units on a scale Standard Deviation 2.29	-1.34 units on a scale Standard Deviation 1.99	-2.13 units on a scale Standard Deviation 2.39	-2.17 units on a scale Standard Deviation 2.35	-2.30 units on a scale Standard Deviation 2.36	-2.48 units on a scale Standard Deviation 2.42	-1.42 units on a scale Standard Deviation 1.94
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.70 units on a scale Standard Deviation 2.29	-1.84 units on a scale Standard Deviation 2.19	-1.87 units on a scale Standard Deviation 2.17	-1.99 units on a scale Standard Deviation 2.38	-1.34 units on a scale Standard Deviation 2.06	-1.90 units on a scale Standard Deviation 2.28	-2.05 units on a scale Standard Deviation 2.31	-2.09 units on a scale Standard Deviation 2.35	-2.33 units on a scale Standard Deviation 2.42	-1.53 units on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 2	-1.13 units on a scale Standard Deviation 1.90	-1.15 units on a scale Standard Deviation 1.86	-1.46 units on a scale Standard Deviation 2.03	-1.04 units on a scale Standard Deviation 2.03	-0.93 units on a scale Standard Deviation 1.69	-1.17 units on a scale Standard Deviation 2.05	-0.98 units on a scale Standard Deviation 2.01	-1.23 units on a scale Standard Deviation 1.94	-0.99 units on a scale Standard Deviation 2.12	-0.89 units on a scale Standard Deviation 1.65
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 4	-1.74 units on a scale Standard Deviation 2.06	-1.98 units on a scale Standard Deviation 1.90	-2.18 units on a scale Standard Deviation 2.13	-2.13 units on a scale Standard Deviation 2.13	-1.15 units on a scale Standard Deviation 1.95	-1.87 units on a scale Standard Deviation 2.36	-1.84 units on a scale Standard Deviation 2.12	-2.06 units on a scale Standard Deviation 2.26	-2.07 units on a scale Standard Deviation 2.23	-1.07 units on a scale Standard Deviation 1.85
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 8	-1.78 units on a scale Standard Deviation 2.26	-2.25 units on a scale Standard Deviation 2.05	-2.31 units on a scale Standard Deviation 2.26	-2.41 units on a scale Standard Deviation 2.19	-1.20 units on a scale Standard Deviation 2.01	-2.03 units on a scale Standard Deviation 2.39	-2.15 units on a scale Standard Deviation 2.25	-2.22 units on a scale Standard Deviation 2.29	-2.41 units on a scale Standard Deviation 2.34	-1.16 units on a scale Standard Deviation 1.94
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 12	-2.08 units on a scale Standard Deviation 2.31	-2.20 units on a scale Standard Deviation 2.09	-2.52 units on a scale Standard Deviation 2.14	-2.58 units on a scale Standard Deviation 2.32	-1.37 units on a scale Standard Deviation 2.14	-2.40 units on a scale Standard Deviation 2.52	-2.37 units on a scale Standard Deviation 2.55	-2.40 units on a scale Standard Deviation 2.44	-2.59 units on a scale Standard Deviation 2.39	-1.33 units on a scale Standard Deviation 1.97
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 16	-2.05 units on a scale Standard Deviation 2.22	-2.24 units on a scale Standard Deviation 2.16	-2.48 units on a scale Standard Deviation 2.17	-2.57 units on a scale Standard Deviation 2.27	-1.45 units on a scale Standard Deviation 2.10	-2.31 units on a scale Standard Deviation 2.51	-2.29 units on a scale Standard Deviation 2.38	-2.36 units on a scale Standard Deviation 2.46	-2.53 units on a scale Standard Deviation 2.48	-1.45 units on a scale Standard Deviation 2.03
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 24	-2.10 units on a scale Standard Deviation 2.37	-2.18 units on a scale Standard Deviation 2.19	-2.30 units on a scale Standard Deviation 2.22	-2.36 units on a scale Standard Deviation 2.40	-1.58 units on a scale Standard Deviation 2.24	-2.16 units on a scale Standard Deviation 2.41	-2.28 units on a scale Standard Deviation 2.33	-2.22 units on a scale Standard Deviation 2.45	-2.46 units on a scale Standard Deviation 2.49	-1.58 units on a scale Standard Deviation 2.13
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 32	-1.96 units on a scale Standard Deviation 2.44	-2.10 units on a scale Standard Deviation 2.24	-2.20 units on a scale Standard Deviation 2.26	-2.35 units on a scale Standard Deviation 2.42	-1.64 units on a scale Standard Deviation 2.29	-2.10 units on a scale Standard Deviation 2.44	-2.20 units on a scale Standard Deviation 2.44	-2.30 units on a scale Standard Deviation 2.51	-2.22 units on a scale Standard Deviation 2.52	-1.53 units on a scale Standard Deviation 2.15
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 40	-1.94 units on a scale Standard Deviation 2.43	-1.99 units on a scale Standard Deviation 2.35	-1.99 units on a scale Standard Deviation 2.31	-2.14 units on a scale Standard Deviation 2.40	-1.51 units on a scale Standard Deviation 2.26	-2.05 units on a scale Standard Deviation 2.43	-2.07 units on a scale Standard Deviation 2.39	-2.05 units on a scale Standard Deviation 2.50	-2.20 units on a scale Standard Deviation 2.48	-1.49 units on a scale Standard Deviation 2.16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 48	-1.91 units on a scale Standard Deviation 2.44	-2.02 units on a scale Standard Deviation 2.39	-1.96 units on a scale Standard Deviation 2.36	-2.08 units on a scale Standard Deviation 2.33	-1.48 units on a scale Standard Deviation 2.28	-1.94 units on a scale Standard Deviation 2.40	-2.00 units on a scale Standard Deviation 2.40	-2.10 units on a scale Standard Deviation 2.50	-2.08 units on a scale Standard Deviation 2.48	-1.40 units on a scale Standard Deviation 2.16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 56	-1.89 units on a scale Standard Deviation 2.43	-1.93 units on a scale Standard Deviation 2.36	-1.93 units on a scale Standard Deviation 2.36	-1.99 units on a scale Standard Deviation 2.32	-1.43 units on a scale Standard Deviation 2.25	-1.90 units on a scale Standard Deviation 2.33	-1.81 units on a scale Standard Deviation 2.36	-1.98 units on a scale Standard Deviation 2.46	-2.07 units on a scale Standard Deviation 2.48	-1.42 units on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Baseline	6.22 units on a scale Standard Deviation 1.83	6.37 units on a scale Standard Deviation 1.97	6.34 units on a scale Standard Deviation 1.87	6.13 units on a scale Standard Deviation 1.96	6.12 units on a scale Standard Deviation 2.08	6.28 units on a scale Standard Deviation 1.83	6.30 units on a scale Standard Deviation 1.88	6.21 units on a scale Standard Deviation 1.97	6.14 units on a scale Standard Deviation 1.97	6.10 units on a scale Standard Deviation 1.83
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.05 units on a scale Standard Deviation 2.24	-1.02 units on a scale Standard Deviation 2.43	-1.31 units on a scale Standard Deviation 2.24	-0.87 units on a scale Standard Deviation 2.43	-0.80 units on a scale Standard Deviation 2.08	-1.04 units on a scale Standard Deviation 2.34	-0.68 units on a scale Standard Deviation 2.49	-1.01 units on a scale Standard Deviation 2.24	-0.86 units on a scale Standard Deviation 2.51	-0.86 units on a scale Standard Deviation 2.04
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.67 units on a scale Standard Deviation 2.37	-1.88 units on a scale Standard Deviation 2.39	-1.98 units on a scale Standard Deviation 2.19	-1.92 units on a scale Standard Deviation 2.34	-1.04 units on a scale Standard Deviation 2.47	-1.49 units on a scale Standard Deviation 2.58	-1.64 units on a scale Standard Deviation 2.44	-1.88 units on a scale Standard Deviation 2.53	-1.93 units on a scale Standard Deviation 2.45	-0.95 units on a scale Standard Deviation 2.27
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.57 units on a scale Standard Deviation 2.64	-1.95 units on a scale Standard Deviation 2.51	-1.93 units on a scale Standard Deviation 2.53	-2.09 units on a scale Standard Deviation 2.50	-1.05 units on a scale Standard Deviation 2.33	-1.67 units on a scale Standard Deviation 2.50	-1.84 units on a scale Standard Deviation 2.50	-2.11 units on a scale Standard Deviation 2.44	-2.26 units on a scale Standard Deviation 2.58	-1.11 units on a scale Standard Deviation 2.40
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.74 units on a scale Standard Deviation 2.53	-1.78 units on a scale Standard Deviation 2.38	-2.15 units on a scale Standard Deviation 2.38	-2.22 units on a scale Standard Deviation 2.51	-1.10 units on a scale Standard Deviation 2.34	-2.04 units on a scale Standard Deviation 2.54	-2.02 units on a scale Standard Deviation 2.84	-2.20 units on a scale Standard Deviation 2.73	-2.25 units on a scale Standard Deviation 2.61	-1.35 units on a scale Standard Deviation 2.24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.71 units on a scale Standard Deviation 2.40	-1.77 units on a scale Standard Deviation 2.61	-1.95 units on a scale Standard Deviation 2.49	-2.19 units on a scale Standard Deviation 2.49	-1.23 units on a scale Standard Deviation 2.32	-1.94 units on a scale Standard Deviation 2.69	-1.91 units on a scale Standard Deviation 2.66	-2.08 units on a scale Standard Deviation 2.75	-2.22 units on a scale Standard Deviation 2.69	-1.38 units on a scale Standard Deviation 2.28
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.56 units on a scale Standard Deviation 2.49	-1.65 units on a scale Standard Deviation 2.47	-1.64 units on a scale Standard Deviation 2.47	-1.83 units on a scale Standard Deviation 2.51	-1.20 units on a scale Standard Deviation 2.33	-1.63 units on a scale Standard Deviation 2.61	-1.88 units on a scale Standard Deviation 2.65	-1.96 units on a scale Standard Deviation 2.71	-2.06 units on a scale Standard Deviation 2.72	-1.55 units on a scale Standard Deviation 2.33

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 16	-1.93 units on a scale Standard Deviation 2.50	-2.00 units on a scale Standard Deviation 2.74	-2.20 units on a scale Standard Deviation 2.55	-2.44 units on a scale Standard Deviation 2.51	-1.33 units on a scale Standard Deviation 2.52	-2.03 units on a scale Standard Deviation 2.85	-1.98 units on a scale Standard Deviation 2.81	-2.11 units on a scale Standard Deviation 2.91	-2.25 units on a scale Standard Deviation 2.83	-1.42 units on a scale Standard Deviation 2.41
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 2	-1.05 units on a scale Standard Deviation 2.24	-1.02 units on a scale Standard Deviation 2.43	-1.31 units on a scale Standard Deviation 2.24	-0.87 units on a scale Standard Deviation 2.43	-0.80 units on a scale Standard Deviation 2.08	-1.04 units on a scale Standard Deviation 2.34	-0.68 units on a scale Standard Deviation 2.49	-1.01 units on a scale Standard Deviation 2.24	-0.86 units on a scale Standard Deviation 2.51	-0.86 units on a scale Standard Deviation 2.04
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 4	-1.65 units on a scale Standard Deviation 2.40	-1.92 units on a scale Standard Deviation 2.41	-2.01 units on a scale Standard Deviation 2.18	-1.99 units on a scale Standard Deviation 2.36	-1.04 units on a scale Standard Deviation 2.51	-1.54 units on a scale Standard Deviation 2.65	-1.59 units on a scale Standard Deviation 2.51	-1.84 units on a scale Standard Deviation 2.62	-1.91 units on a scale Standard Deviation 2.51	-0.96 units on a scale Standard Deviation 2.28
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 8	-1.65 units on a scale Standard Deviation 2.69	-2.09 units on a scale Standard Deviation 2.62	-2.08 units on a scale Standard Deviation 2.53	-2.26 units on a scale Standard Deviation 2.52	-1.07 units on a scale Standard Deviation 2.45	-1.73 units on a scale Standard Deviation 2.64	-1.85 units on a scale Standard Deviation 2.62	-2.06 units on a scale Standard Deviation 2.60	-2.22 units on a scale Standard Deviation 2.71	-1.13 units on a scale Standard Deviation 2.45
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 12	-1.93 units on a scale Standard Deviation 2.62	-1.98 units on a scale Standard Deviation 2.53	-2.32 units on a scale Standard Deviation 2.38	-2.41 units on a scale Standard Deviation 2.57	-1.20 units on a scale Standard Deviation 2.54	-2.11 units on a scale Standard Deviation 2.71	-2.08 units on a scale Standard Deviation 2.97	-2.20 units on a scale Standard Deviation 2.86	-2.27 units on a scale Standard Deviation 2.76	-1.36 units on a scale Standard Deviation 2.33
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 24	-1.95 units on a scale Standard Deviation 2.64	-1.94 units on a scale Standard Deviation 2.68	-1.98 units on a scale Standard Deviation 2.61	-2.15 units on a scale Standard Deviation 2.59	-1.36 units on a scale Standard Deviation 2.62	-1.79 units on a scale Standard Deviation 2.79	-1.97 units on a scale Standard Deviation 2.86	-2.04 units on a scale Standard Deviation 2.89	-2.15 units on a scale Standard Deviation 2.87	-1.64 units on a scale Standard Deviation 2.52
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 32	-1.78 units on a scale Standard Deviation 2.72	-1.80 units on a scale Standard Deviation 2.85	-1.91 units on a scale Standard Deviation 2.61	-2.12 units on a scale Standard Deviation 2.67	-1.45 units on a scale Standard Deviation 2.71	-1.78 units on a scale Standard Deviation 2.87	-1.80 units on a scale Standard Deviation 2.99	-1.96 units on a scale Standard Deviation 2.89	-1.89 units on a scale Standard Deviation 3.00	-1.56 units on a scale Standard Deviation 2.48
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 40	-1.69 units on a scale Standard Deviation 2.76	-1.78 units on a scale Standard Deviation 2.92	-1.69 units on a scale Standard Deviation 2.69	-1.77 units on a scale Standard Deviation 2.71	-1.23 units on a scale Standard Deviation 2.66	-1.72 units on a scale Standard Deviation 2.75	-1.75 units on a scale Standard Deviation 2.84	-1.73 units on a scale Standard Deviation 2.92	-1.89 units on a scale Standard Deviation 2.95	-1.40 units on a scale Standard Deviation 2.53
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 48	-1.63 units on a scale Standard Deviation 2.81	-1.72 units on a scale Standard Deviation 2.92	-1.68 units on a scale Standard Deviation 2.76	-1.78 units on a scale Standard Deviation 2.64	-1.22 units on a scale Standard Deviation 2.67	-1.62 units on a scale Standard Deviation 2.72	-1.64 units on a scale Standard Deviation 2.92	-1.79 units on a scale Standard Deviation 2.90	-1.74 units on a scale Standard Deviation 2.98	-1.33 units on a scale Standard Deviation 2.60
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 56	-1.65 units on a scale Standard Deviation 2.79	-1.64 units on a scale Standard Deviation 2.92	-1.68 units on a scale Standard Deviation 2.76	-1.73 units on a scale Standard Deviation 2.63	-1.15 units on a scale Standard Deviation 2.62	-1.61 units on a scale Standard Deviation 2.62	-1.42 units on a scale Standard Deviation 2.89	-1.67 units on a scale Standard Deviation 2.92	-1.72 units on a scale Standard Deviation 2.94	-1.36 units on a scale Standard Deviation 2.63

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24	-1.82 units on a scale Standard Deviation 2.66	-2.01 units on a scale Standard Deviation 2.67	-2.02 units on a scale Standard Deviation 2.52	-2.22 units on a scale Standard Deviation 2.74	-1.51 units on a scale Standard Deviation 2.28	-2.02 units on a scale Standard Deviation 2.74	-2.28 units on a scale Standard Deviation 2.63	-2.47 units on a scale Standard Deviation 2.90	-2.63 units on a scale Standard Deviation 2.76	-1.73 units on a scale Standard Deviation 2.33
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Baseline	7.55 units on a scale Standard Deviation 1.80	7.68 units on a scale Standard Deviation 1.78	7.72 units on a scale Standard Deviation 1.69	7.50 units on a scale Standard Deviation 1.73	7.40 units on a scale Standard Deviation 1.87	7.80 units on a scale Standard Deviation 1.71	7.59 units on a scale Standard Deviation 1.77	7.55 units on a scale Standard Deviation 1.77	7.54 units on a scale Standard Deviation 1.78	7.52 units on a scale Standard Deviation 1.70
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.29 units on a scale Standard Deviation 2.23	-1.34 units on a scale Standard Deviation 2.33	-1.67 units on a scale Standard Deviation 2.39	-1.36 units on a scale Standard Deviation 2.42	-0.94 units on a scale Standard Deviation 2.19	-1.41 units on a scale Standard Deviation 2.39	-1.23 units on a scale Standard Deviation 2.31	-1.45 units on a scale Standard Deviation 2.43	-1.37 units on a scale Standard Deviation 2.18	-1.05 units on a scale Standard Deviation 2.08
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.78 units on a scale Standard Deviation 2.31	-2.13 units on a scale Standard Deviation 2.30	-2.46 units on a scale Standard Deviation 2.55	-2.32 units on a scale Standard Deviation 2.44	-1.22 units on a scale Standard Deviation 2.38	-2.05 units on a scale Standard Deviation 2.65	-2.07 units on a scale Standard Deviation 2.35	-2.43 units on a scale Standard Deviation 2.63	-2.36 units on a scale Standard Deviation 2.43	-1.29 units on a scale Standard Deviation 2.21
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.79 units on a scale Standard Deviation 2.50	-2.32 units on a scale Standard Deviation 2.49	-2.41 units on a scale Standard Deviation 2.62	-2.53 units on a scale Standard Deviation 2.60	-1.34 units on a scale Standard Deviation 2.27	-2.17 units on a scale Standard Deviation 2.63	-2.26 units on a scale Standard Deviation 2.58	-2.48 units on a scale Standard Deviation 2.56	-2.65 units on a scale Standard Deviation 2.59	-1.33 units on a scale Standard Deviation 2.04
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12	-2.09 units on a scale Standard Deviation 2.69	-2.16 units on a scale Standard Deviation 2.59	-2.49 units on a scale Standard Deviation 2.57	-2.67 units on a scale Standard Deviation 2.66	-1.37 units on a scale Standard Deviation 2.37	-2.45 units on a scale Standard Deviation 2.71	-2.52 units on a scale Standard Deviation 2.78	-2.48 units on a scale Standard Deviation 2.72	-2.79 units on a scale Standard Deviation 2.64	-1.50 units on a scale Standard Deviation 2.10
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.99 units on a scale Standard Deviation 2.60	-2.20 units on a scale Standard Deviation 2.65	-2.35 units on a scale Standard Deviation 2.47	-2.53 units on a scale Standard Deviation 2.64	-1.53 units on a scale Standard Deviation 2.29	-2.39 units on a scale Standard Deviation 2.71	-2.35 units on a scale Standard Deviation 2.68	-2.52 units on a scale Standard Deviation 2.76	-2.76 units on a scale Standard Deviation 2.77	-1.66 units on a scale Standard Deviation 2.17

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=286 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=282 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=255 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 2	-1.29 units on a scale Standard Deviation 2.23	-1.34 units on a scale Standard Deviation 2.33	-1.67 units on a scale Standard Deviation 2.39	-1.36 units on a scale Standard Deviation 2.42	-0.94 units on a scale Standard Deviation 2.19	-1.41 units on a scale Standard Deviation 2.39	-1.23 units on a scale Standard Deviation 2.31	-1.45 units on a scale Standard Deviation 2.43	-1.37 units on a scale Standard Deviation 2.18	-1.05 units on a scale Standard Deviation 2.08
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 4	-1.80 units on a scale Standard Deviation 2.31	-2.20 units on a scale Standard Deviation 2.31	-2.51 units on a scale Standard Deviation 2.55	-2.41 units on a scale Standard Deviation 2.44	-1.26 units on a scale Standard Deviation 2.39	-2.14 units on a scale Standard Deviation 2.68	-2.05 units on a scale Standard Deviation 2.39	-2.43 units on a scale Standard Deviation 2.70	-2.37 units on a scale Standard Deviation 2.44	-1.30 units on a scale Standard Deviation 2.20
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 8	-1.90 units on a scale Standard Deviation 2.55	-2.48 units on a scale Standard Deviation 2.52	-2.62 units on a scale Standard Deviation 2.61	-2.75 units on a scale Standard Deviation 2.59	-1.35 units on a scale Standard Deviation 2.37	-2.27 units on a scale Standard Deviation 2.68	-2.37 units on a scale Standard Deviation 2.61	-2.50 units on a scale Standard Deviation 2.67	-2.71 units on a scale Standard Deviation 2.60	-1.35 units on a scale Standard Deviation 2.08
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 12	-2.29 units on a scale Standard Deviation 2.70	-2.40 units on a scale Standard Deviation 2.60	-2.76 units on a scale Standard Deviation 2.52	-2.94 units on a scale Standard Deviation 2.65	-1.47 units on a scale Standard Deviation 2.52	-2.64 units on a scale Standard Deviation 2.78	-2.69 units on a scale Standard Deviation 2.83	-2.57 units on a scale Standard Deviation 2.81	-2.90 units on a scale Standard Deviation 2.64	-1.55 units on a scale Standard Deviation 2.17
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 16	-2.23 units on a scale Standard Deviation 2.63	-2.47 units on a scale Standard Deviation 2.65	-2.70 units on a scale Standard Deviation 2.45	-2.88 units on a scale Standard Deviation 2.59	-1.63 units on a scale Standard Deviation 2.46	-2.62 units on a scale Standard Deviation 2.78	-2.53 units on a scale Standard Deviation 2.73	-2.59 units on a scale Standard Deviation 2.87	-2.89 units on a scale Standard Deviation 2.75	-1.75 units on a scale Standard Deviation 2.24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 24	-2.26 units on a scale Standard Deviation 2.73	-2.38 units on a scale Standard Deviation 2.71	-2.48 units on a scale Standard Deviation 2.55	-2.66 units on a scale Standard Deviation 2.73	-1.74 units on a scale Standard Deviation 2.53	-2.35 units on a scale Standard Deviation 2.84	-2.57 units on a scale Standard Deviation 2.71	-2.60 units on a scale Standard Deviation 2.99	-2.83 units on a scale Standard Deviation 2.78	-1.84 units on a scale Standard Deviation 2.44
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 32	-2.12 units on a scale Standard Deviation 2.75	-2.28 units on a scale Standard Deviation 2.74	-2.43 units on a scale Standard Deviation 2.72	-2.62 units on a scale Standard Deviation 2.84	-1.70 units on a scale Standard Deviation 2.52	-2.27 units on a scale Standard Deviation 2.80	-2.50 units on a scale Standard Deviation 2.84	-2.52 units on a scale Standard Deviation 2.98	-2.55 units on a scale Standard Deviation 2.90	-1.78 units on a scale Standard Deviation 2.48
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 40	-2.06 units on a scale Standard Deviation 2.66	-2.21 units on a scale Standard Deviation 2.73	-2.09 units on a scale Standard Deviation 2.59	-2.41 units on a scale Standard Deviation 2.80	-1.51 units on a scale Standard Deviation 2.45	-2.31 units on a scale Standard Deviation 2.78	-2.28 units on a scale Standard Deviation 2.77	-2.26 units on a scale Standard Deviation 2.95	-2.47 units on a scale Standard Deviation 2.87	-1.76 units on a scale Standard Deviation 2.46
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 48	-1.99 units on a scale Standard Deviation 2.69	-2.17 units on a scale Standard Deviation 2.74	-2.10 units on a scale Standard Deviation 2.74	-2.29 units on a scale Standard Deviation 2.74	-1.48 units on a scale Standard Deviation 2.47	-2.20 units on a scale Standard Deviation 2.79	-2.24 units on a scale Standard Deviation 2.84	-2.30 units on a scale Standard Deviation 2.91	-2.31 units on a scale Standard Deviation 2.89	-1.64 units on a scale Standard Deviation 2.47
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 56	-2.00 units on a scale Standard Deviation 2.70	-2.08 units on a scale Standard Deviation 2.76	-2.10 units on a scale Standard Deviation 2.72	-2.24 units on a scale Standard Deviation 2.70	-1.43 units on a scale Standard Deviation 2.45	-2.16 units on a scale Standard Deviation 2.75	-1.98 units on a scale Standard Deviation 2.78	-2.16 units on a scale Standard Deviation 2.89	-2.34 units on a scale Standard Deviation 2.84	-1.71 units on a scale Standard Deviation 2.51

SECONDARY outcome

Timeframe: Baseline, Weeks 12 and 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. 'Number analyzed' signifies participants evaluable at specified time points.

The SF-36 health survey is 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 scores represent better health status.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Social function at baseline	65.63 units on a scale Standard Deviation 25.65	65.97 units on a scale Standard Deviation 26.68	68.13 units on a scale Standard Deviation 24.43	64.47 units on a scale Standard Deviation 25.28	62.23 units on a scale Standard Deviation 26.33	63.19 units on a scale Standard Deviation 24.26	63.68 units on a scale Standard Deviation 25.44	64.51 units on a scale Standard Deviation 24.58	66.90 units on a scale Standard Deviation 24.16	64.31 units on a scale Standard Deviation 24.07
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) General health at baseline	56.76 units on a scale Standard Deviation 20.74	57.41 units on a scale Standard Deviation 21.03	60.66 units on a scale Standard Deviation 20.88	57.92 units on a scale Standard Deviation 22.08	57.61 units on a scale Standard Deviation 21.97	56.20 units on a scale Standard Deviation 20.62	56.93 units on a scale Standard Deviation 20.48	56.34 units on a scale Standard Deviation 20.39	58.27 units on a scale Standard Deviation 20.65	55.69 units on a scale Standard Deviation 22.22
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Physical function at baseline	32.82 units on a scale Standard Deviation 19.12	32.74 units on a scale Standard Deviation 21.34	34.79 units on a scale Standard Deviation 20.63	33.88 units on a scale Standard Deviation 18.66	35.46 units on a scale Standard Deviation 19.94	33.43 units on a scale Standard Deviation 20.62	34.79 units on a scale Standard Deviation 19.21	33.41 units on a scale Standard Deviation 22.07	35.11 units on a scale Standard Deviation 20.48	32.81 units on a scale Standard Deviation 19.57
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Role physical at baseline	43.29 units on a scale Standard Deviation 25.54	43.88 units on a scale Standard Deviation 23.81	44.58 units on a scale Standard Deviation 23.90	44.69 units on a scale Standard Deviation 23.60	46.09 units on a scale Standard Deviation 24.57	42.59 units on a scale Standard Deviation 23.69	42.86 units on a scale Standard Deviation 23.46	42.65 units on a scale Standard Deviation 24.90	45.60 units on a scale Standard Deviation 22.57	43.55 units on a scale Standard Deviation 22.70
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Bodily pain at baseline	36.91 units on a scale Standard Deviation 17.91	35.90 units on a scale Standard Deviation 17.87	37.80 units on a scale Standard Deviation 17.49	37.67 units on a scale Standard Deviation 17.89	35.72 units on a scale Standard Deviation 16.34	34.14 units on a scale Standard Deviation 16.39	35.57 units on a scale Standard Deviation 18.00	34.11 units on a scale Standard Deviation 16.66	36.47 units on a scale Standard Deviation 16.93	36.96 units on a scale Standard Deviation 17.60
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Vitality at baseline	51.58 units on a scale Standard Deviation 19.45	51.28 units on a scale Standard Deviation 20.10	53.73 units on a scale Standard Deviation 19.83	52.57 units on a scale Standard Deviation 19.76	50.78 units on a scale Standard Deviation 18.94	50.52 units on a scale Standard Deviation 18.21	51.52 units on a scale Standard Deviation 21.07	51.45 units on a scale Standard Deviation 19.16	53.63 units on a scale Standard Deviation 18.42	51.52 units on a scale Standard Deviation 17.90
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Role emotional at baseline	66.08 units on a scale Standard Deviation 29.30	66.35 units on a scale Standard Deviation 28.15	67.74 units on a scale Standard Deviation 29.39	67.92 units on a scale Standard Deviation 29.42	68.45 units on a scale Standard Deviation 28.65	63.02 units on a scale Standard Deviation 28.66	64.07 units on a scale Standard Deviation 28.31	62.68 units on a scale Standard Deviation 29.21	65.05 units on a scale Standard Deviation 28.53	63.39 units on a scale Standard Deviation 28.73
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Mental health at baseline	70.42 units on a scale Standard Deviation 19.16	70.23 units on a scale Standard Deviation 19.71	72.20 units on a scale Standard Deviation 19.67	70.40 units on a scale Standard Deviation 18.77	70.34 units on a scale Standard Deviation 19.78	70.95 units on a scale Standard Deviation 17.94	71.08 units on a scale Standard Deviation 19.16	68.25 units on a scale Standard Deviation 19.23	71.07 units on a scale Standard Deviation 19.83	69.08 units on a scale Standard Deviation 18.69
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: General health	3.29 units on a scale Standard Deviation 14.32	4.66 units on a scale Standard Deviation 15.19	3.66 units on a scale Standard Deviation 15.27	5.14 units on a scale Standard Deviation 15.96	3.88 units on a scale Standard Deviation 15.25	5.46 units on a scale Standard Deviation 14.25	3.37 units on a scale Standard Deviation 15.13	5.18 units on a scale Standard Deviation 13.96	5.66 units on a scale Standard Deviation 16.53	4.68 units on a scale Standard Deviation 16.00
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Physical function	11.68 units on a scale Standard Deviation 22.48	12.88 units on a scale Standard Deviation 21.49	14.23 units on a scale Standard Deviation 25.26	14.38 units on a scale Standard Deviation 24.59	5.76 units on a scale Standard Deviation 21.38	12.70 units on a scale Standard Deviation 22.24	9.05 units on a scale Standard Deviation 22.01	13.84 units on a scale Standard Deviation 24.37	12.99 units on a scale Standard Deviation 24.30	7.48 units on a scale Standard Deviation 18.88
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Role physical	9.73 units on a scale Standard Deviation 25.90	12.59 units on a scale Standard Deviation 24.75	13.13 units on a scale Standard Deviation 24.85	15.39 units on a scale Standard Deviation 26.13	6.70 units on a scale Standard Deviation 23.58	13.36 units on a scale Standard Deviation 25.67	10.04 units on a scale Standard Deviation 26.31	15.51 units on a scale Standard Deviation 26.62	13.71 units on a scale Standard Deviation 25.39	7.58 units on a scale Standard Deviation 23.58
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Bodily pain	11.44 units on a scale Standard Deviation 21.66	13.08 units on a scale Standard Deviation 21.93	14.41 units on a scale Standard Deviation 22.41	16.53 units on a scale Standard Deviation 22.55	7.83 units on a scale Standard Deviation 19.22	16.74 units on a scale Standard Deviation 21.52	12.50 units on a scale Standard Deviation 22.60	17.15 units on a scale Standard Deviation 23.61	16.83 units on a scale Standard Deviation 22.01	8.01 units on a scale Standard Deviation 19.68
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Vitality	5.68 units on a scale Standard Deviation 17.68	5.14 units on a scale Standard Deviation 17.69	6.47 units on a scale Standard Deviation 17.84	6.12 units on a scale Standard Deviation 18.16	3.97 units on a scale Standard Deviation 15.62	7.41 units on a scale Standard Deviation 17.89	4.35 units on a scale Standard Deviation 17.88	6.32 units on a scale Standard Deviation 17.13	6.47 units on a scale Standard Deviation 17.88	2.43 units on a scale Standard Deviation 15.51
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Social function	5.90 units on a scale Standard Deviation 24.79	5.25 units on a scale Standard Deviation 23.40	5.36 units on a scale Standard Deviation 23.74	7.76 units on a scale Standard Deviation 23.66	7.41 units on a scale Standard Deviation 24.36	10.19 units on a scale Standard Deviation 25.95	5.36 units on a scale Standard Deviation 25.97	8.14 units on a scale Standard Deviation 24.30	8.94 units on a scale Standard Deviation 23.90	3.33 units on a scale Standard Deviation 23.87
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Role emotional	5.08 units on a scale Standard Deviation 26.90	5.50 units on a scale Standard Deviation 25.83	4.91 units on a scale Standard Deviation 25.97	4.47 units on a scale Standard Deviation 24.64	0.92 units on a scale Standard Deviation 23.38	8.23 units on a scale Standard Deviation 28.14	3.64 units on a scale Standard Deviation 28.43	8.63 units on a scale Standard Deviation 26.82	6.82 units on a scale Standard Deviation 26.37	4.13 units on a scale Standard Deviation 24.69
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 12: Mental health	2.85 units on a scale Standard Deviation 17.25	3.28 units on a scale Standard Deviation 15.58	0.96 units on a scale Standard Deviation 16.77	3.04 units on a scale Standard Deviation 15.36	1.57 units on a scale Standard Deviation 15.44	3.00 units on a scale Standard Deviation 15.55	0.36 units on a scale Standard Deviation 16.85	3.78 units on a scale Standard Deviation 17.45	3.17 units on a scale Standard Deviation 17.39	0.67 units on a scale Standard Deviation 15.99
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: General health	3.08 units on a scale Standard Deviation 13.39	2.95 units on a scale Standard Deviation 15.61	3.77 units on a scale Standard Deviation 14.43	4.54 units on a scale Standard Deviation 14.38	2.90 units on a scale Standard Deviation 14.43	4.07 units on a scale Standard Deviation 15.59	4.25 units on a scale Standard Deviation 16.34	3.46 units on a scale Standard Deviation 14.82	4.28 units on a scale Standard Deviation 15.77	3.90 units on a scale Standard Deviation 15.80
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Physical function	10.52 units on a scale Standard Deviation 21.56	9.50 units on a scale Standard Deviation 22.90	9.83 units on a scale Standard Deviation 22.63	12.30 units on a scale Standard Deviation 24.18	5.75 units on a scale Standard Deviation 19.12	10.40 units on a scale Standard Deviation 22.45	9.33 units on a scale Standard Deviation 19.85	11.83 units on a scale Standard Deviation 23.45	12.00 units on a scale Standard Deviation 23.60	8.00 units on a scale Standard Deviation 18.72
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Role physical	9.40 units on a scale Standard Deviation 25.04	7.42 units on a scale Standard Deviation 26.32	9.58 units on a scale Standard Deviation 25.13	11.54 units on a scale Standard Deviation 25.10	7.28 units on a scale Standard Deviation 22.16	10.24 units on a scale Standard Deviation 23.60	10.46 units on a scale Standard Deviation 25.88	10.93 units on a scale Standard Deviation 25.86	10.50 units on a scale Standard Deviation 23.87	7.70 units on a scale Standard Deviation 20.85
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Bodily pain	10.73 units on a scale Standard Deviation 21.66	9.63 units on a scale Standard Deviation 22.77	10.41 units on a scale Standard Deviation 21.52	13.04 units on a scale Standard Deviation 21.24	8.87 units on a scale Standard Deviation 19.60	10.69 units on a scale Standard Deviation 21.07	10.22 units on a scale Standard Deviation 23.32	14.02 units on a scale Standard Deviation 23.34	13.47 units on a scale Standard Deviation 21.19	8.72 units on a scale Standard Deviation 19.45
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Vitality	5.94 units on a scale Standard Deviation 16.70	3.93 units on a scale Standard Deviation 18.24	3.77 units on a scale Standard Deviation 16.18	4.52 units on a scale Standard Deviation 16.59	1.90 units on a scale Standard Deviation 14.77	5.71 units on a scale Standard Deviation 17.61	4.00 units on a scale Standard Deviation 18.26	2.84 units on a scale Standard Deviation 17.03	4.15 units on a scale Standard Deviation 16.64	2.87 units on a scale Standard Deviation 16.25
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Social function	4.01 units on a scale Standard Deviation 25.13	3.21 units on a scale Standard Deviation 26.84	3.21 units on a scale Standard Deviation 22.32	6.14 units on a scale Standard Deviation 22.56	6.16 units on a scale Standard Deviation 23.26	7.63 units on a scale Standard Deviation 23.13	6.25 units on a scale Standard Deviation 25.58	7.06 units on a scale Standard Deviation 25.35	5.78 units on a scale Standard Deviation 22.67	4.07 units on a scale Standard Deviation 21.74
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Role emotional	3.35 units on a scale Standard Deviation 23.83	0.58 units on a scale Standard Deviation 25.64	2.38 units on a scale Standard Deviation 22.42	2.16 units on a scale Standard Deviation 22.64	2.92 units on a scale Standard Deviation 22.96	5.81 units on a scale Standard Deviation 26.42	4.95 units on a scale Standard Deviation 25.97	6.47 units on a scale Standard Deviation 24.20	3.39 units on a scale Standard Deviation 24.12	2.23 units on a scale Standard Deviation 23.18
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) Change at Week 24: Mental health	2.31 units on a scale Standard Deviation 17.07	1.48 units on a scale Standard Deviation 16.93	0.95 units on a scale Standard Deviation 15.78	2.26 units on a scale Standard Deviation 15.92	1.52 units on a scale Standard Deviation 14.67	1.33 units on a scale Standard Deviation 14.50	0.42 units on a scale Standard Deviation 15.32	0.94 units on a scale Standard Deviation 15.01	0.87 units on a scale Standard Deviation 16.48	0.00 units on a scale Standard Deviation 16.15

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 40, and 56

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. 'Number analyzed' signifies participants evaluable at specified time points.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 12: General health	3.29 units on a scale Standard Deviation 14.32	4.66 units on a scale Standard Deviation 15.19	3.66 units on a scale Standard Deviation 15.27	5.14 units on a scale Standard Deviation 15.96	3.88 units on a scale Standard Deviation 15.25	5.46 units on a scale Standard Deviation 14.25	3.37 units on a scale Standard Deviation 15.13	5.18 units on a scale Standard Deviation 13.96	5.66 units on a scale Standard Deviation 16.53	4.68 units on a scale Standard Deviation 16.00
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 12: Physical function	32.82 units on a scale Standard Deviation 19.12	32.74 units on a scale Standard Deviation 21.34	34.79 units on a scale Standard Deviation 20.63	33.88 units on a scale Standard Deviation 18.66	35.46 units on a scale Standard Deviation 19.94	12.70 units on a scale Standard Deviation 22.24	9.05 units on a scale Standard Deviation 22.01	13.84 units on a scale Standard Deviation 24.37	12.99 units on a scale Standard Deviation 24.30	7.48 units on a scale Standard Deviation 18.88
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 12: Role physical	43.29 units on a scale Standard Deviation 25.54	43.88 units on a scale Standard Deviation 23.81	44.58 units on a scale Standard Deviation 23.90	44.69 units on a scale Standard Deviation 23.60	46.09 units on a scale Standard Deviation 24.57	13.36 units on a scale Standard Deviation 25.67	10.04 units on a scale Standard Deviation 26.31	15.51 units on a scale Standard Deviation 26.62	13.71 units on a scale Standard Deviation 25.39	7.58 units on a scale Standard Deviation 23.58
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 12: Bodily pain	11.44 units on a scale Standard Deviation 21.66	13.08 units on a scale Standard Deviation 21.93	14.41 units on a scale Standard Deviation 22.41	16.53 units on a scale Standard Deviation 22.55	7.83 units on a scale Standard Deviation 19.22	16.74 units on a scale Standard Deviation 21.52	12.50 units on a scale Standard Deviation 22.60	17.15 units on a scale Standard Deviation 23.61	16.83 units on a scale Standard Deviation 22.01	8.01 units on a scale Standard Deviation 19.68
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 12: Vitality	5.68 units on a scale Standard Deviation 17.68	5.14 units on a scale Standard Deviation 17.69	6.47 units on a scale Standard Deviation 17.84	6.12 units on a scale Standard Deviation 18.16	3.97 units on a scale Standard Deviation 15.62	7.41 units on a scale Standard Deviation 17.89	4.35 units on a scale Standard Deviation 17.88	6.32 units on a scale Standard Deviation 17.13	6.47 units on a scale Standard Deviation 17.88	2.43 units on a scale Standard Deviation 15.51
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 12: Social function	5.90 units on a scale Standard Deviation 24.79	5.25 units on a scale Standard Deviation 23.40	5.36 units on a scale Standard Deviation 23.74	7.76 units on a scale Standard Deviation 23.66	7.41 units on a scale Standard Deviation 24.36	10.19 units on a scale Standard Deviation 25.95	5.36 units on a scale Standard Deviation 25.97	8.14 units on a scale Standard Deviation 24.30	8.94 units on a scale Standard Deviation 23.90	3.33 units on a scale Standard Deviation 23.87
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 12: Role emotional	5.08 units on a scale Standard Deviation 26.90	5.50 units on a scale Standard Deviation 25.83	4.91 units on a scale Standard Deviation 25.97	4.47 units on a scale Standard Deviation 24.64	0.92 units on a scale Standard Deviation 23.38	8.23 units on a scale Standard Deviation 28.14	3.64 units on a scale Standard Deviation 28.43	8.63 units on a scale Standard Deviation 26.82	6.82 units on a scale Standard Deviation 26.37	4.13 units on a scale Standard Deviation 24.69
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 12: Mental health	2.85 units on a scale Standard Deviation 17.25	3.28 units on a scale Standard Deviation 15.58	0.96 units on a scale Standard Deviation 16.77	3.04 units on a scale Standard Deviation 15.36	1.57 units on a scale Standard Deviation 15.44	3.00 units on a scale Standard Deviation 15.55	0.36 units on a scale Standard Deviation 16.85	3.78 units on a scale Standard Deviation 17.45	3.17 units on a scale Standard Deviation 17.39	0.67 units on a scale Standard Deviation 15.99
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 24: General health	3.95 units on a scale Standard Deviation 14.92	3.18 units on a scale Standard Deviation 16.54	3.93 units on a scale Standard Deviation 16.09	4.66 units on a scale Standard Deviation 15.46	3.77 units on a scale Standard Deviation 16.48	4.42 units on a scale Standard Deviation 15.98	4.59 units on a scale Standard Deviation 17.08	3.72 units on a scale Standard Deviation 15.54	4.62 units on a scale Standard Deviation 16.60	4.45 units on a scale Standard Deviation 16.75
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 24: Physical function	11.70 units on a scale Standard Deviation 22.93	11.35 units on a scale Standard Deviation 24.40	10.85 units on a scale Standard Deviation 24.77	13.73 units on a scale Standard Deviation 24.60	6.43 units on a scale Standard Deviation 21.08	11.23 units on a scale Standard Deviation 23.56	10.00 units on a scale Standard Deviation 21.47	12.92 units on a scale Standard Deviation 24.02	12.91 units on a scale Standard Deviation 24.35	8.41 units on a scale Standard Deviation 20.14
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 24: Role physical	11.14 units on a scale Standard Deviation 26.65	9.53 units on a scale Standard Deviation 28.68	10.71 units on a scale Standard Deviation 26.82	13.03 units on a scale Standard Deviation 26.16	7.97 units on a scale Standard Deviation 24.14	11.74 units on a scale Standard Deviation 24.66	11.84 units on a scale Standard Deviation 27.30	11.84 units on a scale Standard Deviation 27.49	12.45 units on a scale Standard Deviation 24.96	8.27 units on a scale Standard Deviation 22.89
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 24: Bodily pain	12.95 units on a scale Standard Deviation 22.92	11.63 units on a scale Standard Deviation 24.07	11.75 units on a scale Standard Deviation 23.05	14.73 units on a scale Standard Deviation 21.67	9.19 units on a scale Standard Deviation 21.10	12.24 units on a scale Standard Deviation 21.85	12.00 units on a scale Standard Deviation 24.21	15.22 units on a scale Standard Deviation 24.37	14.83 units on a scale Standard Deviation 21.76	9.09 units on a scale Standard Deviation 20.09
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 24: Vitality	7.17 units on a scale Standard Deviation 18.11	4.34 units on a scale Standard Deviation 18.95	4.42 units on a scale Standard Deviation 18.09	5.48 units on a scale Standard Deviation 18.13	2.57 units on a scale Standard Deviation 16.19	5.95 units on a scale Standard Deviation 18.32	4.87 units on a scale Standard Deviation 19.75	3.09 units on a scale Standard Deviation 17.82	4.50 units on a scale Standard Deviation 18.07	2.40 units on a scale Standard Deviation 17.96
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 24: Social function	5.19 units on a scale Standard Deviation 27.51	3.56 units on a scale Standard Deviation 28.56	2.81 units on a scale Standard Deviation 24.00	7.11 units on a scale Standard Deviation 23.55	7.32 units on a scale Standard Deviation 25.07	8.51 units on a scale Standard Deviation 24.64	7.09 units on a scale Standard Deviation 27.25	7.35 units on a scale Standard Deviation 26.34	6.57 units on a scale Standard Deviation 24.56	3.97 units on a scale Standard Deviation 24.47
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 24: Role emotional	5.22 units on a scale Standard Deviation 26.39	1.56 units on a scale Standard Deviation 27.95	3.63 units on a scale Standard Deviation 24.03	3.10 units on a scale Standard Deviation 24.18	2.59 units on a scale Standard Deviation 25.68	6.73 units on a scale Standard Deviation 28.21	5.09 units on a scale Standard Deviation 28.41	6.83 units on a scale Standard Deviation 25.37	4.58 units on a scale Standard Deviation 26.67	2.76 units on a scale Standard Deviation 25.33
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 24: Mental health	2.90 units on a scale Standard Deviation 18.22	1.51 units on a scale Standard Deviation 17.97	0.45 units on a scale Standard Deviation 17.97	2.65 units on a scale Standard Deviation 16.96	1.38 units on a scale Standard Deviation 16.71	1.37 units on a scale Standard Deviation 15.33	0.30 units on a scale Standard Deviation 16.71	1.39 units on a scale Standard Deviation 15.75	1.06 units on a scale Standard Deviation 18.13	0.20 units on a scale Standard Deviation 18.25
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 40: General health	3.40 units on a scale Standard Deviation 15.54	2.45 units on a scale Standard Deviation 16.52	2.83 units on a scale Standard Deviation 16.57	3.87 units on a scale Standard Deviation 16.28	3.47 units on a scale Standard Deviation 16.07	3.74 units on a scale Standard Deviation 15.63	3.31 units on a scale Standard Deviation 16.35	3.20 units on a scale Standard Deviation 15.93	3.45 units on a scale Standard Deviation 16.95	4.09 units on a scale Standard Deviation 16.42
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 40: Physical function	10.00 units on a scale Standard Deviation 22.96	10.23 units on a scale Standard Deviation 24.17	10.49 units on a scale Standard Deviation 24.89	11.96 units on a scale Standard Deviation 25.30	6.23 units on a scale Standard Deviation 19.34	9.91 units on a scale Standard Deviation 22.72	8.74 units on a scale Standard Deviation 21.92	12.32 units on a scale Standard Deviation 24.17	11.78 units on a scale Standard Deviation 25.11	7.24 units on a scale Standard Deviation 20.71
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 40: Role physical	9.64 units on a scale Standard Deviation 26.06	8.79 units on a scale Standard Deviation 27.05	10.98 units on a scale Standard Deviation 26.99	10.00 units on a scale Standard Deviation 26.77	7.01 units on a scale Standard Deviation 23.65	11.32 units on a scale Standard Deviation 25.78	10.53 units on a scale Standard Deviation 26.49	12.38 units on a scale Standard Deviation 28.71	12.13 units on a scale Standard Deviation 24.46	7.58 units on a scale Standard Deviation 23.43
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 40: Bodily pain	11.27 units on a scale Standard Deviation 23.45	10.73 units on a scale Standard Deviation 23.77	10.79 units on a scale Standard Deviation 23.42	12.42 units on a scale Standard Deviation 21.98	7.11 units on a scale Standard Deviation 19.38	11.45 units on a scale Standard Deviation 21.91	10.87 units on a scale Standard Deviation 23.44	13.96 units on a scale Standard Deviation 23.88	13.28 units on a scale Standard Deviation 21.69	8.17 units on a scale Standard Deviation 19.11
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 40: Vitality	5.92 units on a scale Standard Deviation 17.95	3.30 units on a scale Standard Deviation 19.26	4.42 units on a scale Standard Deviation 18.61	4.45 units on a scale Standard Deviation 18.58	2.32 units on a scale Standard Deviation 17.09	5.29 units on a scale Standard Deviation 18.95	4.40 units on a scale Standard Deviation 19.47	3.24 units on a scale Standard Deviation 17.68	4.17 units on a scale Standard Deviation 16.83	2.67 units on a scale Standard Deviation 18.06
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Social function at Week 40	4.05 units on a scale Standard Deviation 27.36	3.21 units on a scale Standard Deviation 28.09	2.19 units on a scale Standard Deviation 23.43	4.56 units on a scale Standard Deviation 25.07	7.23 units on a scale Standard Deviation 24.46	7.43 units on a scale Standard Deviation 25.14	6.20 units on a scale Standard Deviation 27.82	6.03 units on a scale Standard Deviation 25.56	6.23 units on a scale Standard Deviation 25.29	2.65 units on a scale Standard Deviation 25.28
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 40: Role emotional	4.08 units on a scale Standard Deviation 27.04	1.91 units on a scale Standard Deviation 26.29	2.80 units on a scale Standard Deviation 24.30	0.76 units on a scale Standard Deviation 25.47	1.61 units on a scale Standard Deviation 26.00	6.69 units on a scale Standard Deviation 27.88	2.99 units on a scale Standard Deviation 30.27	5.98 units on a scale Standard Deviation 27.72	5.47 units on a scale Standard Deviation 26.06	3.41 units on a scale Standard Deviation 27.05
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 40: Mental health	2.16 units on a scale Standard Deviation 19.27	1.41 units on a scale Standard Deviation 17.56	0.25 units on a scale Standard Deviation 18.14	1.76 units on a scale Standard Deviation 16.34	0.49 units on a scale Standard Deviation 16.26	1.22 units on a scale Standard Deviation 16.42	0.26 units on a scale Standard Deviation 18.11	1.22 units on a scale Standard Deviation 15.48	1.11 units on a scale Standard Deviation 17.41	0.82 units on a scale Standard Deviation 18.76
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 56: General health	3.12 units on a scale Standard Deviation 15.53	2.31 units on a scale Standard Deviation 16.84	2.59 units on a scale Standard Deviation 16.83	3.69 units on a scale Standard Deviation 16.54	3.33 units on a scale Standard Deviation 16.26	3.75 units on a scale Standard Deviation 14.82	3.41 units on a scale Standard Deviation 16.14	3.10 units on a scale Standard Deviation 15.85	3.75 units on a scale Standard Deviation 16.71	3.99 units on a scale Standard Deviation 16.87
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 56: Physical function	9.95 units on a scale Standard Deviation 22.78	9.19 units on a scale Standard Deviation 24.31	10.19 units on a scale Standard Deviation 24.94	11.15 units on a scale Standard Deviation 25.00	5.95 units on a scale Standard Deviation 19.75	10.12 units on a scale Standard Deviation 22.91	8.25 units on a scale Standard Deviation 21.73	12.07 units on a scale Standard Deviation 24.08	11.48 units on a scale Standard Deviation 24.80	6.91 units on a scale Standard Deviation 20.39
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 56: Role physical	9.13 units on a scale Standard Deviation 26.00	8.01 units on a scale Standard Deviation 27.09	10.49 units on a scale Standard Deviation 26.86	9.01 units on a scale Standard Deviation 26.81	7.19 units on a scale Standard Deviation 23.29	11.20 units on a scale Standard Deviation 25.54	10.46 units on a scale Standard Deviation 26.83	11.96 units on a scale Standard Deviation 28.82	12.06 units on a scale Standard Deviation 24.38	7.28 units on a scale Standard Deviation 23.78
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 56: Bodily pain	11.58 units on a scale Standard Deviation 23.00	10.21 units on a scale Standard Deviation 24.18	10.38 units on a scale Standard Deviation 23.28	11.92 units on a scale Standard Deviation 22.25	7.47 units on a scale Standard Deviation 19.17	11.52 units on a scale Standard Deviation 21.79	10.32 units on a scale Standard Deviation 23.48	13.53 units on a scale Standard Deviation 24.12	13.36 units on a scale Standard Deviation 21.53	8.69 units on a scale Standard Deviation 19.35
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 56: Vitality	5.70 units on a scale Standard Deviation 18.10	3.10 units on a scale Standard Deviation 19.16	4.17 units on a scale Standard Deviation 18.73	3.82 units on a scale Standard Deviation 18.90	2.68 units on a scale Standard Deviation 16.53	4.82 units on a scale Standard Deviation 18.47	4.47 units on a scale Standard Deviation 19.74	3.41 units on a scale Standard Deviation 17.70	4.15 units on a scale Standard Deviation 16.66	2.08 units on a scale Standard Deviation 17.89
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 56: Social function	4.53 units on a scale Standard Deviation 26.95	2.95 units on a scale Standard Deviation 28.04	1.65 units on a scale Standard Deviation 23.40	3.99 units on a scale Standard Deviation 24.98	7.23 units on a scale Standard Deviation 23.97	7.73 units on a scale Standard Deviation 25.15	6.10 units on a scale Standard Deviation 27.69	6.23 units on a scale Standard Deviation 26.15	6.67 units on a scale Standard Deviation 24.59	2.84 units on a scale Standard Deviation 25.01
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 56: Role emotional	4.23 units on a scale Standard Deviation 28.30	1.53 units on a scale Standard Deviation 26.76	1.99 units on a scale Standard Deviation 24.59	0.47 units on a scale Standard Deviation 25.50	1.67 units on a scale Standard Deviation 25.90	6.10 units on a scale Standard Deviation 28.74	3.25 units on a scale Standard Deviation 30.06	6.11 units on a scale Standard Deviation 28.11	5.07 units on a scale Standard Deviation 26.11	3.51 units on a scale Standard Deviation 27.41
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) Change at Week 56: Mental health	2.28 units on a scale Standard Deviation 19.24	1.42 units on a scale Standard Deviation 17.72	-0.11 units on a scale Standard Deviation 18.49	1.53 units on a scale Standard Deviation 16.55	0.41 units on a scale Standard Deviation 16.13	1.10 units on a scale Standard Deviation 16.47	0.18 units on a scale Standard Deviation 18.05	1.47 units on a scale Standard Deviation 15.63	1.25 units on a scale Standard Deviation 17.22	0.96 units on a scale Standard Deviation 18.44

SECONDARY outcome

Timeframe: Baseline up to Week 56

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

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Number of Participants Who Had Discontinued Study Due to Lack of Efficacy	23 Participants	23 Participants	22 Participants	15 Participants	40 Participants	19 Participants	21 Participants	15 Participants	18 Participants	38 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 56

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

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

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Time to Discontinuation Due to Lack of Efficacy	319.87 days Standard Error 3.74	331.69 days Standard Error 3.65	394.80 days Standard Error 5.08	271.89 days Standard Error 2.66	306.11 days Standard Error 4.94	329.79 days Standard Error 3.68	314.16 days Standard Error 4.15	334.84 days Standard Error 3.08	324.25 days Standard Error 3.32	303.08 days Standard Error 5.10

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=101 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=103 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=99 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=121 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=114 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=76 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=77 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=92 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=84 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=90 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)	-0.88 change in percent work time missed Standard Deviation 11.54	0.04 change in percent work time missed Standard Deviation 8.16	0.63 change in percent work time missed Standard Deviation 6.23	-0.77 change in percent work time missed Standard Deviation 15.75	1.11 change in percent work time missed Standard Deviation 12.55	-2.85 change in percent work time missed Standard Deviation 10.19	-0.42 change in percent work time missed Standard Deviation 12.87	1.51 change in percent work time missed Standard Deviation 11.21	-1.64 change in percent work time missed Standard Deviation 9.60	-0.61 change in percent work time missed Standard Deviation 8.36

SECONDARY outcome

Timeframe: Baseline, Week 24 and 56

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=101 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=103 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=99 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=121 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=114 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=76 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=77 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=92 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=84 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=90 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) Change at Week 24	-0.88 change in percent work time missed Standard Deviation 11.54	0.04 change in percent work time missed Standard Deviation 8.16	0.63 change in percent work time missed Standard Deviation 6.23	0.77 change in percent work time missed Standard Deviation 15.75	1.11 change in percent work time missed Standard Deviation 12.55	-2.85 change in percent work time missed Standard Deviation 10.19	-0.42 change in percent work time missed Standard Deviation 12.87	1.51 change in percent work time missed Standard Deviation 11.21	-1.64 change in percent work time missed Standard Deviation 9.60	-0.61 change in percent work time missed Standard Deviation 8.36
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) Change at Week 56	-1.10 change in percent work time missed Standard Deviation 11.30	-0.39 change in percent work time missed Standard Deviation 9.29	1.08 change in percent work time missed Standard Deviation 7.57	-0.41 change in percent work time missed Standard Deviation 16.46	2.26 change in percent work time missed Standard Deviation 13.76	-3.06 change in percent work time missed Standard Deviation 9.98	-0.46 change in percent work time missed Standard Deviation 12.88	1.51 change in percent work time missed Standard Deviation 11.21	-1.64 change in percent work time missed Standard Deviation 9.60	-0.82 change in percent work time missed Standard Deviation 7.94

SECONDARY outcome

Timeframe: Baseline, Week 24

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=100 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=101 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=98 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=120 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=113 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=73 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=73 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=89 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=80 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=86 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)	-11.90 change in percent impairment Standard Deviation 22.32	-11.68 change in percent impairment Standard Deviation 24.74	-5.51 change in percent impairment Standard Deviation 26.33	-13.00 change in percent impairment Standard Deviation 27.34	-7.35 change in percent impairment Standard Deviation 29.03	-17.81 change in percent impairment Standard Deviation 22.00	-13.01 change in percent impairment Standard Deviation 25.91	-9.33 change in percent impairment Standard Deviation 22.40	-9.63 change in percent impairment Standard Deviation 23.68	-5.81 change in percent impairment Standard Deviation 22.62

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 56

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=100 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=101 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=98 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=120 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=113 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=73 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=73 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=89 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=80 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=86 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) Change at Week 24	-11.90 change in percent impairment Standard Deviation 22.32	-11.68 change in percent impairment Standard Deviation 24.74	-5.51 change in percent impairment Standard Deviation 26.33	-13.00 change in percent impairment Standard Deviation 27.34	-7.35 change in percent impairment Standard Deviation 29.03	-17.81 change in percent impairment Standard Deviation 22.00	-13.01 change in percent impairment Standard Deviation 25.91	-9.33 change in percent impairment Standard Deviation 22.40	-9.63 change in percent impairment Standard Deviation 23.68	-5.81 change in percent impairment Standard Deviation 22.62
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) Change at Week 56	-10.30 change in percent impairment Standard Deviation 23.11	-11.88 change in percent impairment Standard Deviation 24.85	-4.08 change in percent impairment Standard Deviation 25.92	-11.33 change in percent impairment Standard Deviation 27.19	-5.31 change in percent impairment Standard Deviation 28.51	-16.99 change in percent impairment Standard Deviation 22.09	-12.88 change in percent impairment Standard Deviation 27.00	-8.09 change in percent impairment Standard Deviation 24.58	-4.25 change in percent impairment Standard Deviation 42.03	-5.93 change in percent impairment Standard Deviation 22.30

SECONDARY outcome

Timeframe: Baseline, Week 24

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))\*(Q5/10)\]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=101 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=103 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=99 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=121 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=114 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=77 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=92 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=84 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=90 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF	-5.40 change in percent work impairment Standard Deviation 31.08	-1.46 change in percent work impairment Standard Deviation 24.95	-0.75 change in percent work impairment Standard Deviation 18.60	-1.35 change in percent work impairment Standard Deviation 29.85	2.09 change in percent work impairment Standard Deviation 28.55	-10.17 change in percent work impairment Standard Deviation 26.46	-0.22 change in percent work impairment Standard Deviation 22.51	1.25 change in percent work impairment Standard Deviation 26.81	-4.30 change in percent work impairment Standard Deviation 24.16	-2.29 change in percent work impairment Standard Deviation 23.87

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 56

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))\*(Q5/10)\]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=101 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=103 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=99 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=121 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=114 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=76 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=77 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=92 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=84 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=90 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF Change at Week 24	-5.40 change in percent work impairment Standard Deviation 31.08	-1.46 change in percent work impairment Standard Deviation 24.95	-0.75 change in percent work impairment Standard Deviation 18.60	-1.35 change in percent work impairment Standard Deviation 29.85	2.09 change in percent work impairment Standard Deviation 28.55	-10.17 change in percent work impairment Standard Deviation 26.46	-0.22 change in percent work impairment Standard Deviation 22.51	1.25 change in percent work impairment Standard Deviation 26.81	-4.30 change in percent work impairment Standard Deviation 24.16	-2.29 change in percent work impairment Standard Deviation 23.87
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF Change at Week 56	-6.08 change in percent work impairment Standard Deviation 30.20	-1.88 change in percent work impairment Standard Deviation 26.61	0.77 change in percent work impairment Standard Deviation 22.05	-0.85 change in percent work impairment Standard Deviation 31.85	4.11 change in percent work impairment Standard Deviation 27.38	-10.32 change in percent work impairment Standard Deviation 26.52	-1.01 change in percent work impairment Standard Deviation 23.22	1.25 change in percent work impairment Standard Deviation 26.81	-4.30 change in percent work impairment Standard Deviation 24.16	-3.02 change in percent work impairment Standard Deviation 21.60

SECONDARY outcome

Timeframe: Baseline, Week 24

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=283 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=279 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=284 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=280 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=250 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=249 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=253 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)	-12.30 change in percent activity impairment Standard Deviation 25.61	-15.51 change in percent activity impairment Standard Deviation 26.17	-13.55 change in percent activity impairment Standard Deviation 26.42	-14.96 change in percent activity impairment Standard Deviation 26.74	-10.00 change in percent activity impairment Standard Deviation 25.92	-17.24 change in percent activity impairment Standard Deviation 25.11	-17.84 change in percent activity impairment Standard Deviation 25.81	-18.04 change in percent activity impairment Standard Deviation 25.47	-17.31 change in percent activity impairment Standard Deviation 26.28	-11.90 change in percent activity impairment Standard Deviation 26.06

SECONDARY outcome

Timeframe: Baseline, Weeks 24, and 56

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=283 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=287 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=279 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=284 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=280 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=250 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=255 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=249 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=253 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) Change at Week 24	-12.30 change in percent activity impairment Standard Deviation 25.61	-15.51 change in percent activity impairment Standard Deviation 26.17	-13.55 change in percent activity impairment Standard Deviation 26.42	-14.96 change in percent activity impairment Standard Deviation 26.74	-10.00 change in percent activity impairment Standard Deviation 25.92	-17.24 change in percent activity impairment Standard Deviation 25.11	-17.84 change in percent activity impairment Standard Deviation 25.81	-18.04 change in percent activity impairment Standard Deviation 25.47	-17.31 change in percent activity impairment Standard Deviation 26.28	-11.90 change in percent activity impairment Standard Deviation 26.06
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) Change at Week 56	-12.12 change in percent activity impairment Standard Deviation 25.37	-14.77 change in percent activity impairment Standard Deviation 26.72	-12.19 change in percent activity impairment Standard Deviation 27.03	-13.20 change in percent activity impairment Standard Deviation 26.58	-9.32 change in percent activity impairment Standard Deviation 24.93	-15.39 change in percent activity impairment Standard Deviation 23.53	-15.76 change in percent activity impairment Standard Deviation 27.09	-18.04 change in percent activity impairment Standard Deviation 25.93	-15.86 change in percent activity impairment Standard Deviation 26.91	-11.19 change in percent activity impairment Standard Deviation 26.55

SECONDARY outcome

Timeframe: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.

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

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 1-2	60.5 percentage of participants	59.3 percentage of participants	57.6 percentage of participants	62.9 percentage of participants	61.9 percentage of participants	69.7 percentage of participants	64.2 percentage of participants	60.2 percentage of participants	62.5 percentage of participants	63.2 percentage of participants
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 3-4	63.3 percentage of participants	61.8 percentage of participants	55.1 percentage of participants	60.6 percentage of participants	62.3 percentage of participants	68.4 percentage of participants	64.9 percentage of participants	59.3 percentage of participants	60.3 percentage of participants	66.0 percentage of participants
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 5-8	67.7 percentage of participants	64.7 percentage of participants	55.1 percentage of participants	57.9 percentage of participants	68.8 percentage of participants	68.0 percentage of participants	61.2 percentage of participants	62.5 percentage of participants	63.9 percentage of participants	66.7 percentage of participants
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 9-12	67.8 percentage of participants	65.3 percentage of participants	56.3 percentage of participants	61.4 percentage of participants	64.8 percentage of participants	62.9 percentage of participants	64.5 percentage of participants	60.3 percentage of participants	57.1 percentage of participants	65.9 percentage of participants
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 13-16	66.7 percentage of participants	63.7 percentage of participants	62.1 percentage of participants	57.8 percentage of participants	68.1 percentage of participants	64.2 percentage of participants	61.3 percentage of participants	62.3 percentage of participants	57.8 percentage of participants	68.8 percentage of participants
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 17-24	68.9 percentage of participants	67.0 percentage of participants	64.7 percentage of participants	66.0 percentage of participants	76.6 percentage of participants	67.0 percentage of participants	65.1 percentage of participants	59.4 percentage of participants	66.2 percentage of participants	66.3 percentage of participants
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 25-32	66.0 percentage of participants	67.3 percentage of participants	59.1 percentage of participants	59.6 percentage of participants	69.5 percentage of participants	66.5 percentage of participants	70.2 percentage of participants	63.5 percentage of participants	66.2 percentage of participants	71.2 percentage of participants
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 33-40	64.4 percentage of participants	69.5 percentage of participants	58.2 percentage of participants	61.8 percentage of participants	73.7 percentage of participants	63.8 percentage of participants	71.2 percentage of participants	64.8 percentage of participants	61.8 percentage of participants	61.6 percentage of participants
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 41-48	66.7 percentage of participants	62.5 percentage of participants	59.2 percentage of participants	60.9 percentage of participants	66.0 percentage of participants	64.1 percentage of participants	70.7 percentage of participants	63.3 percentage of participants	52.5 percentage of participants	65.1 percentage of participants
Percentage of Participants Who Used Rescue Medication: Observed Data Weeks 49-56	69.2 percentage of participants	71.1 percentage of participants	62.9 percentage of participants	74.2 percentage of participants	78.2 percentage of participants	75.9 percentage of participants	74.1 percentage of participants	72.4 percentage of participants	79.3 percentage of participants	77.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 1-2	60.4 percentage of participants	59.4 percentage of participants	56.9 percentage of participants	63.0 percentage of participants	63.0 percentage of participants	70.0 percentage of participants	64.4 percentage of participants	60.5 percentage of participants	62.7 percentage of participants	63.1 percentage of participants
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 3-4	63.0 percentage of participants	61.7 percentage of participants	54.7 percentage of participants	60.7 percentage of participants	63.0 percentage of participants	69.4 percentage of participants	64.4 percentage of participants	59.2 percentage of participants	61.1 percentage of participants	66.0 percentage of participants
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 5-8	66.5 percentage of participants	63.8 percentage of participants	55.0 percentage of participants	58.9 percentage of participants	69.8 percentage of participants	69.8 percentage of participants	61.0 percentage of participants	62.4 percentage of participants	64.3 percentage of participants	67.6 percentage of participants
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 9-12	65.8 percentage of participants	64.2 percentage of participants	55.4 percentage of participants	60.3 percentage of participants	66.2 percentage of participants	65.1 percentage of participants	63.9 percentage of participants	60.5 percentage of participants	59.3 percentage of participants	68.4 percentage of participants
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 13-16	65.3 percentage of participants	62.5 percentage of participants	60.0 percentage of participants	57.8 percentage of participants	69.4 percentage of participants	67.5 percentage of participants	62.3 percentage of participants	62.5 percentage of participants	59.7 percentage of participants	70.7 percentage of participants
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 17-24	68.1 percentage of participants	64.6 percentage of participants	63.2 percentage of participants	64.5 percentage of participants	75.8 percentage of participants	69.8 percentage of participants	64.3 percentage of participants	60.9 percentage of participants	65.6 percentage of participants	69.1 percentage of participants
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 25-32	66.7 percentage of participants	64.9 percentage of participants	60.0 percentage of participants	63.1 percentage of participants	70.8 percentage of participants	71.8 percentage of participants	67.5 percentage of participants	63.7 percentage of participants	66.4 percentage of participants	74.2 percentage of participants
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 33-40	68.1 percentage of participants	66.3 percentage of participants	61.8 percentage of participants	64.1 percentage of participants	71.9 percentage of participants	71.4 percentage of participants	67.5 percentage of participants	62.9 percentage of participants	65.2 percentage of participants	71.5 percentage of participants
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 41-48	69.5 percentage of participants	66.0 percentage of participants	63.9 percentage of participants	64.8 percentage of participants	71.5 percentage of participants	71.4 percentage of participants	67.9 percentage of participants	63.7 percentage of participants	65.0 percentage of participants	72.3 percentage of participants
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) Weeks 49-56	71.2 percentage of participants	69.1 percentage of participants	65.4 percentage of participants	67.6 percentage of participants	72.6 percentage of participants	71.5 percentage of participants	70.0 percentage of participants	66.8 percentage of participants	68.1 percentage of participants	71.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56

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

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Amount of Rescue Medication Used Weeks 1-2	3144.66 milligram (mg) Standard Deviation 6878.90	3365.46 milligram (mg) Standard Deviation 8829.47	2739.96 milligram (mg) Standard Deviation 7060.72	3524.27 milligram (mg) Standard Deviation 5665.78	3543.99 milligram (mg) Standard Deviation 5541.14	3132.30 milligram (mg) Standard Deviation 4047.15	3834.79 milligram (mg) Standard Deviation 7152.17	2910.68 milligram (mg) Standard Deviation 4285.74	3250.69 milligram (mg) Standard Deviation 4846.02	3455.85 milligram (mg) Standard Deviation 8154.84
Amount of Rescue Medication Used Weeks 3-4	3411.93 milligram (mg) Standard Deviation 6929.86	3582.77 milligram (mg) Standard Deviation 8814.22	2660.11 milligram (mg) Standard Deviation 6782.71	3066.65 milligram (mg) Standard Deviation 5206.51	3415.52 milligram (mg) Standard Deviation 5260.63	3255.16 milligram (mg) Standard Deviation 4142.25	3769.17 milligram (mg) Standard Deviation 7131.76	2672.18 milligram (mg) Standard Deviation 4108.60	3011.67 milligram (mg) Standard Deviation 4412.94	3281.23 milligram (mg) Standard Deviation 6981.13
Amount of Rescue Medication Used Weeks 5-8	2846.58 milligram (mg) Standard Deviation 6532.40	2875.55 milligram (mg) Standard Deviation 8372.63	2131.45 milligram (mg) Standard Deviation 6429.73	2396.99 milligram (mg) Standard Deviation 4684.26	2991.01 milligram (mg) Standard Deviation 4634.26	2571.99 milligram (mg) Standard Deviation 3240.96	2969.34 milligram (mg) Standard Deviation 6656.34	2140.44 milligram (mg) Standard Deviation 3585.06	2223.15 milligram (mg) Standard Deviation 3624.98	3182.45 milligram (mg) Standard Deviation 6991.76
Amount of Rescue Medication Used Weeks 9-12	2863.10 milligram (mg) Standard Deviation 6547.23	2955.84 milligram (mg) Standard Deviation 8403.06	2291.41 milligram (mg) Standard Deviation 6478.22	2415.93 milligram (mg) Standard Deviation 4630.96	2919.20 milligram (mg) Standard Deviation 4643.38	2380.78 milligram (mg) Standard Deviation 3162.61	3008.85 milligram (mg) Standard Deviation 6675.65	2166.23 milligram (mg) Standard Deviation 3632.39	2266.13 milligram (mg) Standard Deviation 3753.34	3067.56 milligram (mg) Standard Deviation 6962.68
Amount of Rescue Medication Used Weeks 13-16	2993.63 milligram (mg) Standard Deviation 6587.61	2912.14 milligram (mg) Standard Deviation 8426.72	2562.94 milligram (mg) Standard Deviation 6525.59	2551.21 milligram (mg) Standard Deviation 4793.92	2920.39 milligram (mg) Standard Deviation 4659.70	2450.55 milligram (mg) Standard Deviation 3280.41	2938.95 milligram (mg) Standard Deviation 6667.26	2244.74 milligram (mg) Standard Deviation 3642.93	2486.23 milligram (mg) Standard Deviation 3933.41	3269.78 milligram (mg) Standard Deviation 7040.71
Amount of Rescue Medication Used Weeks 17-24	2733.43 milligram (mg) Standard Deviation 6432.63	2778.55 milligram (mg) Standard Deviation 8311.86	2525.71 milligram (mg) Standard Deviation 6490.27	2261.93 milligram (mg) Standard Deviation 4517.29	2759.90 milligram (mg) Standard Deviation 4426.38	2261.84 milligram (mg) Standard Deviation 2980.00	2725.86 milligram (mg) Standard Deviation 6619.25	2235.23 milligram (mg) Standard Deviation 3702.39	2370.30 milligram (mg) Standard Deviation 3599.96	2816.00 milligram (mg) Standard Deviation 6854.35
Amount of Rescue Medication Used Weeks 25-32	2823.39 milligram (mg) Standard Deviation 6441.86	2824.83 milligram (mg) Standard Deviation 8313.77	2548.20 milligram (mg) Standard Deviation 6512.08	2289.28 milligram (mg) Standard Deviation 4563.36	2792.04 milligram (mg) Standard Deviation 4555.75	2383.27 milligram (mg) Standard Deviation 3102.23	2927.44 milligram (mg) Standard Deviation 6606.26	2432.81 milligram (mg) Standard Deviation 3783.30	2723.26 milligram (mg) Standard Deviation 3891.04	3126.26 milligram (mg) Standard Deviation 6906.75
Amount of Rescue Medication Used Weeks 33-40	2810.18 milligram (mg) Standard Deviation 6445.83	2900.69 milligram (mg) Standard Deviation 8319.96	2608.91 milligram (mg) Standard Deviation 6529.78	2361.40 milligram (mg) Standard Deviation 4541.68	2755.66 milligram (mg) Standard Deviation 4503.88	2449.87 milligram (mg) Standard Deviation 3126.73	2976.37 milligram (mg) Standard Deviation 6607.95	2428.51 milligram (mg) Standard Deviation 3758.09	2682.35 milligram (mg) Standard Deviation 3925.96	3032.17 milligram (mg) Standard Deviation 6889.07
Amount of Rescue Medication Used Weeks 41-48	2927.31 milligram (mg) Standard Deviation 6460.58	2906.70 milligram (mg) Standard Deviation 8324.75	2673.48 milligram (mg) Standard Deviation 6517.91	2373.66 milligram (mg) Standard Deviation 4547.39	2746.29 milligram (mg) Standard Deviation 4498.19	2521.27 milligram (mg) Standard Deviation 3163.27	3033.87 milligram (mg) Standard Deviation 6627.43	2408.58 milligram (mg) Standard Deviation 3706.60	2618.83 milligram (mg) Standard Deviation 3864.42	3101.63 milligram (mg) Standard Deviation 6912.29
Amount of Rescue Medication Used Weeks 49-56	2979.89 milligram (mg) Standard Deviation 6413.29	2910.73 milligram (mg) Standard Deviation 6626.26	2938.47 milligram (mg) Standard Deviation 6717.61	2545.36 milligram (mg) Standard Deviation 4465.07	3106.46 milligram (mg) Standard Deviation 4908.02	2840.21 milligram (mg) Standard Deviation 3627.85	2770.28 milligram (mg) Standard Deviation 3810.98	2511.61 milligram (mg) Standard Deviation 3797.81	2842.74 milligram (mg) Standard Deviation 3642.86	3035.33 milligram (mg) Standard Deviation 4124.28

SECONDARY outcome

Timeframe: Baseline, Week 56

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=448 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=449 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=446 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=452 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=446 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 Baseline	2.769 millimeter (mm) Standard Deviation 2.077	2.850 millimeter (mm) Standard Deviation 2.077	3.005 millimeter (mm) Standard Deviation 2.068	2.982 millimeter (mm) Standard Deviation 2.106	3.022 millimeter (mm) Standard Deviation 2.090	—	—	—	—	—
Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 Change at Week 56	-0.189 millimeter (mm) Standard Deviation 0.970	-0.213 millimeter (mm) Standard Deviation 1.069	-0.162 millimeter (mm) Standard Deviation 1.069	-0.172 millimeter (mm) Standard Deviation 1.096	-0.041 millimeter (mm) Standard Deviation 0.850	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 56

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=92 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=93 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=90 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=90 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=93 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 Baseline	2.447 millimeter Standard Deviation 1.364	2.372 millimeter Standard Deviation 1.433	2.346 millimeter Standard Deviation 1.424	2.195 millimeter Standard Deviation 1.561	2.724 millimeter Standard Deviation 1.525	—	—	—	—	—
Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 Change at Week 56	-0.075 millimeter Standard Deviation 0.587	-0.137 millimeter Standard Deviation 0.619	-0.240 millimeter Standard Deviation 0.599	-0.136 millimeter Standard Deviation 0.437	-0.028 millimeter Standard Deviation 0.477	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 64

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching 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 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	203 Participants	211 Participants	205 Participants	207 Participants	192 Participants	202 Participants	188 Participants	185 Participants	193 Participants	172 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	22 Participants	23 Participants	28 Participants	30 Participants	22 Participants	22 Participants	23 Participants	26 Participants	34 Participants	21 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score 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 through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Baseline	2.64 units on a scale Standard Deviation 5.96	2.56 units on a scale Standard Deviation 5.82	1.93 units on a scale Standard Deviation 4.34	2.54 units on a scale Standard Deviation 6.43	2.31 units on a scale Standard Deviation 6.34	2.04 units on a scale Standard Deviation 4.55	2.09 units on a scale Standard Deviation 4.00	2.24 units on a scale Standard Deviation 4.84	2.08 units on a scale Standard Deviation 4.86	2.18 units on a scale Standard Deviation 5.20
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 2	-0.20 units on a scale Standard Deviation 1.61	-0.25 units on a scale Standard Deviation 2.27	-0.30 units on a scale Standard Deviation 1.78	-0.16 units on a scale Standard Deviation 1.98	-0.11 units on a scale Standard Deviation 1.94	-0.11 units on a scale Standard Deviation 1.87	-0.29 units on a scale Standard Deviation 2.03	-0.14 units on a scale Standard Deviation 1.60	-0.33 units on a scale Standard Deviation 1.55	-0.34 units on a scale Standard Deviation 1.17
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 4	-0.40 units on a scale Standard Deviation 1.93	-0.42 units on a scale Standard Deviation 2.37	-0.18 units on a scale Standard Deviation 1.68	-0.29 units on a scale Standard Deviation 2.01	-0.11 units on a scale Standard Deviation 2.20	-0.20 units on a scale Standard Deviation 1.51	-0.30 units on a scale Standard Deviation 1.93	-0.41 units on a scale Standard Deviation 1.98	-0.39 units on a scale Standard Deviation 2.27	-0.11 units on a scale Standard Deviation 2.80
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 8	-0.47 units on a scale Standard Deviation 2.17	-0.42 units on a scale Standard Deviation 2.40	-0.22 units on a scale Standard Deviation 1.98	-0.30 units on a scale Standard Deviation 2.05	-0.12 units on a scale Standard Deviation 2.31	-0.32 units on a scale Standard Deviation 2.05	-0.36 units on a scale Standard Deviation 2.29	-0.55 units on a scale Standard Deviation 2.08	-0.22 units on a scale Standard Deviation 3.84	-0.35 units on a scale Standard Deviation 2.06
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 12	-0.53 units on a scale Standard Deviation 2.38	-0.38 units on a scale Standard Deviation 2.95	-0.34 units on a scale Standard Deviation 2.28	-0.62 units on a scale Standard Deviation 3.94	-0.29 units on a scale Standard Deviation 2.65	-0.52 units on a scale Standard Deviation 1.98	-0.56 units on a scale Standard Deviation 2.37	-0.72 units on a scale Standard Deviation 2.29	-0.38 units on a scale Standard Deviation 3.84	-0.44 units on a scale Standard Deviation 2.21
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 16	-0.81 units on a scale Standard Deviation 2.91	-0.41 units on a scale Standard Deviation 2.62	-0.38 units on a scale Standard Deviation 2.70	-0.58 units on a scale Standard Deviation 2.82	-0.26 units on a scale Standard Deviation 2.61	-0.41 units on a scale Standard Deviation 2.25	-0.64 units on a scale Standard Deviation 233	-0.83 units on a scale Standard Deviation 2.41	-0.48 units on a scale Standard Deviation 3.18	-0.50 units on a scale Standard Deviation 2.47
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 24	-0.78 units on a scale Standard Deviation 3.26	-0.50 units on a scale Standard Deviation 2.70	-0.57 units on a scale Standard Deviation 2.27	-0.57 units on a scale Standard Deviation 2.88	-0.43 units on a scale Standard Deviation 2.52	-0.37 units on a scale Standard Deviation 2.42	-0.46 units on a scale Standard Deviation 2.47	-0.99 units on a scale Standard Deviation 2.66	-0.47 units on a scale Standard Deviation 2.83	-0.50 units on a scale Standard Deviation 2.73
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 32	-0.56 units on a scale Standard Deviation 2.71	-0.53 units on a scale Standard Deviation 2.64	-0.78 units on a scale Standard Deviation 2.97	-0.47 units on a scale Standard Deviation 3.51	-0.39 units on a scale Standard Deviation 2.27	-0.50 units on a scale Standard Deviation 2.61	-0.71 units on a scale Standard Deviation 2.44	-1.05 units on a scale Standard Deviation 2.97	-0.49 units on a scale Standard Deviation 2.85	-0.63 units on a scale Standard Deviation 2.72
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 40	-0.61 units on a scale Standard Deviation 2.37	-0.47 units on a scale Standard Deviation 2.91	-0.63 units on a scale Standard Deviation 2.75	-0.38 units on a scale Standard Deviation 3.82	-0.42 units on a scale Standard Deviation 2.77	-0.42 units on a scale Standard Deviation 2.94	-0.58 units on a scale Standard Deviation 2.37	-1.06 units on a scale Standard Deviation 3.09	-0.71 units on a scale Standard Deviation 2.73	-0.73 units on a scale Standard Deviation 2.91
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 48	-0.55 units on a scale Standard Deviation 3.44	-0.81 units on a scale Standard Deviation 2.56	-0.67 units on a scale Standard Deviation 2.77	-0.80 units on a scale Standard Deviation 3.46	-0.48 units on a scale Standard Deviation 2.83	-0.56 units on a scale Standard Deviation 2.74	-0.65 units on a scale Standard Deviation 2.74	-1.07 units on a scale Standard Deviation 3.49	-0.50 units on a scale Standard Deviation 2.74	-0.69 units on a scale Standard Deviation 3.14
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data Change at Week 56	-0.30 units on a scale Standard Deviation 5.01	-0.70 units on a scale Standard Deviation 2.91	-0.83 units on a scale Standard Deviation 4.14	-0.10 units on a scale Standard Deviation 3.27	-0.36 units on a scale Standard Deviation 2.68	-0.53 units on a scale Standard Deviation 2.54	-0.42 units on a scale Standard Deviation 2.51	-1.01 units on a scale Standard Deviation 3.45	-0.38 units on a scale Standard Deviation 2.04	-0.54 units on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 56	-0.48 units on a scale Standard Deviation 3.83	-0.53 units on a scale Standard Deviation 2.76	-0.45 units on a scale Standard Deviation 2.95	-0.58 units on a scale Standard Deviation 3.30	-0.46 units on a scale Standard Deviation 2.72	-0.41 units on a scale Standard Deviation 2.31	-0.44 units on a scale Standard Deviation 2.58	-0.89 units on a scale Standard Deviation 2.90	-0.43 units on a scale Standard Deviation 4.45	-0.41 units on a scale Standard Deviation 3.40
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Baseline	2.64 units on a scale Standard Deviation 5.96	2.56 units on a scale Standard Deviation 5.82	1.93 units on a scale Standard Deviation 4.34	2.54 units on a scale Standard Deviation 6.43	2.31 units on a scale Standard Deviation 6.34	2.04 units on a scale Standard Deviation 4.55	2.09 units on a scale Standard Deviation 4.00	2.24 units on a scale Standard Deviation 4.84	2.08 units on a scale Standard Deviation 4.86	2.18 units on a scale Standard Deviation 5.20
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 2	-0.20 units on a scale Standard Deviation 1.61	-0.25 units on a scale Standard Deviation 2.27	-0.30 units on a scale Standard Deviation 1.78	-0.16 units on a scale Standard Deviation 1.98	-0.11 units on a scale Standard Deviation 1.94	-0.11 units on a scale Standard Deviation 1.87	-0.29 units on a scale Standard Deviation 2.03	-0.14 units on a scale Standard Deviation 1.60	-0.33 units on a scale Standard Deviation 1.55	-0.34 units on a scale Standard Deviation 1.71
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 4	-0.37 units on a scale Standard Deviation 1.88	-0.46 units on a scale Standard Deviation 2.41	-0.20 units on a scale Standard Deviation 1.66	-0.33 units on a scale Standard Deviation 2.42	-0.08 units on a scale Standard Deviation 2.20	-0.21 units on a scale Standard Deviation 1.50	-0.30 units on a scale Standard Deviation 1.90	-0.40 units on a scale Standard Deviation 1.99	-0.40 units on a scale Standard Deviation 2.24	-0.13 units on a scale Standard Deviation 2.79
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 8	-0.49 units on a scale Standard Deviation 2.14	-0.46 units on a scale Standard Deviation 2.38	-0.25 units on a scale Standard Deviation 1.98	-0.38 units on a scale Standard Deviation 2.51	-0.12 units on a scale Standard Deviation 2.29	-0.32 units on a scale Standard Deviation 2.00	-0.35 units on a scale Standard Deviation 2.20	-0.53 units on a scale Standard Deviation 2.06	-0.33 units on a scale Standard Deviation 3.79	-0.22 units on a scale Standard Deviation 2.96
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 12	-0.52 units on a scale Standard Deviation 2.33	-0.43 units on a scale Standard Deviation 2.88	-0.38 units on a scale Standard Deviation 2.25	-0.65 units on a scale Standard Deviation 3.93	-0.26 units on a scale Standard Deviation 2.54	-0.53 units on a scale Standard Deviation 1.93	-0.50 units on a scale Standard Deviation 2.34	-0.69 units on a scale Standard Deviation 2.25	-0.26 units on a scale Standard Deviation 4.78	-0.28 units on a scale Standard Deviation 3.05
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 16	-0.77 units on a scale Standard Deviation 2.77	-0.48 units on a scale Standard Deviation 2.58	-0.35 units on a scale Standard Deviation 2.67	-0.58 units on a scale Standard Deviation 3.02	-0.18 units on a scale Standard Deviation 2.62	-0.43 units on a scale Standard Deviation 2.15	-0.56 units on a scale Standard Deviation 2.28	-0.79 units on a scale Standard Deviation 2.35	-0.30 units on a scale Standard Deviation 4.34	-0.34 units on a scale Standard Deviation 3.20
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 24	-0.73 units on a scale Standard Deviation 3.07	-0.57 units on a scale Standard Deviation 2.67	-0.44 units on a scale Standard Deviation 2.21	-0.60 units on a scale Standard Deviation 3.02	-0.31 units on a scale Standard Deviation 2.49	-0.35 units on a scale Standard Deviation 2.28	-0.38 units on a scale Standard Deviation 2.31	-0.90 units on a scale Standard Deviation 2.53	-0.22 units on a scale Standard Deviation 4.47	-0.36 units on a scale Standard Deviation 3.37
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 32	-0.56 units on a scale Standard Deviation 2.77	-0.57 units on a scale Standard Deviation 2.77	-0.52 units on a scale Standard Deviation 2.76	-0.53 units on a scale Standard Deviation 3.41	-0.32 units on a scale Standard Deviation 2.32	-0.44 units on a scale Standard Deviation 2.38	-0.56 units on a scale Standard Deviation 2.40	-0.93 units on a scale Standard Deviation 2.72	-0.26 units on a scale Standard Deviation 4.44	-0.34 units on a scale Standard Deviation 3.46
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 40	-0.50 units on a scale Standard Deviation 2.65	-0.55 units on a scale Standard Deviation 2.82	-0.32 units on a scale Standard Deviation 2.56	-0.49 units on a scale Standard Deviation 3.57	-0.40 units on a scale Standard Deviation 2.73	-0.41 units on a scale Standard Deviation 2.66	-0.50 units on a scale Standard Deviation 2.37	-0.50 units on a scale Standard Deviation 2.72	-0.33 units on a scale Standard Deviation 4.34	-0.39 units on a scale Standard Deviation 3.52
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Change at Week 48	-0.43 units on a scale Standard Deviation 3.27	-0.58 units on a scale Standard Deviation 2.71	-0.38 units on a scale Standard Deviation 2.56	-0.65 units on a scale Standard Deviation 3.20	-0.43 units on a scale Standard Deviation 2.63	-0.44 units on a scale Standard Deviation 2.40	-0.52 units on a scale Standard Deviation 2.48	-0.87 units on a scale Standard Deviation 2.90	-0.34 units on a scale Standard Deviation 4.40	-0.36 units on a scale Standard Deviation 3.51

SECONDARY outcome

Timeframe: Predose on Day 1, Weeks 16, 24, 40, and 56

Population: Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure and Number analyzed' signifies participants evaluable at specified time points. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. This outcome measure was planned not to be analyzed for placebo reporting arms (Naproxen 500 mg and Celecoxib 100 mg).

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=512 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=517 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=502 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=507 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Plasma Trough (Pre-dose) Concentration of Tanezumab Day 1	48.4570 nanogram/milliliter Standard Deviation 241.4173	164.068 nanogram/milliliter Standard Deviation 1045.628	102.398 nanogram/milliliter Standard Deviation 543.2856	96.4720 nanogram/milliliter Standard Deviation 481.0747	—	—	—	—	—	—
Plasma Trough (Pre-dose) Concentration of Tanezumab Week 16	222.779 nanogram/milliliter Standard Deviation 228.0336	556.854 nanogram/milliliter Standard Deviation 599.8115	255.246 nanogram/milliliter Standard Deviation 400.3175	723.316 nanogram/milliliter Standard Deviation 2791.080	—	—	—	—	—	—
Plasma Trough (Pre-dose) Concentration of Tanezumab Week 24	250.813 nanogram/milliliter Standard Deviation 375.3960	545.672 nanogram/milliliter Standard Deviation 375.3960	271.632 nanogram/milliliter Standard Deviation 368.0965	538.756 nanogram/milliliter Standard Deviation 481.1859	—	—	—	—	—	—
Plasma Trough (Pre-dose) Concentration of Tanezumab Week 40	231.840 nanogram/milliliter Standard Deviation 211.3920	523.214 nanogram/milliliter Standard Deviation 365.6468	263.049 nanogram/milliliter Standard Deviation 289.5641	527.108 nanogram/milliliter Standard Deviation 442.1378	—	—	—	—	—	—
Plasma Trough (Pre-dose) Concentration of Tanezumab Week 56	168.673 nanogram/milliliter Standard Deviation 307.1740	385.733 nanogram/milliliter Standard Deviation 456.5163	138.159 nanogram/milliliter Standard Deviation 253.3517	377.231 nanogram/milliliter Standard Deviation 422.0123	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 48

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

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

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Number of Participants With Intravenous (IV) Doses of Study Medication Number of IV Doses: 1	32 Participants	36 Participants	36 Participants	44 Participants	35 Participants	25 Participants	30 Participants	22 Participants	21 Participants	22 Participants
Number of Participants With Intravenous (IV) Doses of Study Medication Number of IV Doses: 2	19 Participants	18 Participants	19 Participants	16 Participants	30 Participants	15 Participants	19 Participants	12 Participants	12 Participants	24 Participants
Number of Participants With Intravenous (IV) Doses of Study Medication Number of IV Doses: 3	27 Participants	28 Participants	17 Participants	21 Participants	21 Participants	13 Participants	16 Participants	18 Participants	22 Participants	12 Participants
Number of Participants With Intravenous (IV) Doses of Study Medication Number of IV Doses: 4	41 Participants	51 Participants	51 Participants	55 Participants	44 Participants	39 Participants	35 Participants	44 Participants	48 Participants	37 Participants
Number of Participants With Intravenous (IV) Doses of Study Medication Number of IV Doses: 5	71 Participants	70 Participants	66 Participants	74 Participants	74 Participants	82 Participants	78 Participants	84 Participants	72 Participants	73 Participants
Number of Participants With Intravenous (IV) Doses of Study Medication Number of IV Doses: 6	45 Participants	44 Participants	45 Participants	31 Participants	33 Participants	41 Participants	34 Participants	43 Participants	38 Participants	44 Participants
Number of Participants With Intravenous (IV) Doses of Study Medication Number of IV Doses: 7	50 Participants	41 Participants	46 Participants	47 Participants	46 Participants	41 Participants	42 Participants	33 Participants	41 Participants	44 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. This outcome measure was planned not to be analyzed for placebo reporting arms (Naproxen 500 mg and Celecoxib 100 mg).

Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level \>=4.32 for tanezumab were considered ADA positive.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=541 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=542 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=536 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=542 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Number of Participants With Anti-Drug Antibody (ADA) Response Baseline	3 Participants	2 Participants	4 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response Week 16	5 Participants	3 Participants	4 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response Week 24	4 Participants	2 Participants	1 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response Week 40	2 Participants	2 Participants	5 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response Week 56	3 Participants	2 Participants	1 Participants	2 Participants	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 56

Female participants, who reported positive in urine or serum pregnancy test were reported.

Outcome measures

Outcome measures
Measure	Tanezumab 5 mg (Naproxen Exposure) n=200 Participants Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=208 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=184 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=192 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=199 Participants Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=192 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=184 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=179 Participants Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=177 Participants Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=189 Participants Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Number of Participants With Positive Urine or Serum Pregnancy Test	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Tanezumab 5 mg (Naproxen Exposure)

Serious events: 22 serious events

Other events: 201 other events

Deaths: 0 deaths

Tanezumab 10 mg (Naproxen Exposure)

Serious events: 23 serious events

Other events: 205 other events

Deaths: 0 deaths

Tanezumab 5 mg + Naproxen 500 mg

Serious events: 28 serious events

Other events: 201 other events

Deaths: 0 deaths

Tanezumab 10 mg + Naproxen 500 mg

Serious events: 30 serious events

Other events: 202 other events

Deaths: 0 deaths

Naproxen 500 mg

Serious events: 22 serious events

Other events: 188 other events

Deaths: 0 deaths

Tanezumab 5 mg (Celecoxib Exposure)

Serious events: 22 serious events

Other events: 195 other events

Deaths: 0 deaths

Tanezumab 10 mg (Celecoxib Exposure)

Serious events: 23 serious events

Other events: 181 other events

Deaths: 0 deaths

Tanezumab 5 mg + Celecoxib 100 mg

Serious events: 26 serious events

Other events: 182 other events

Deaths: 0 deaths

Tanezumab 10 mg + Celecoxib 100 mg

Serious events: 34 serious events

Other events: 187 other events

Deaths: 0 deaths

Celecoxib 100 mg

Serious events: 21 serious events

Other events: 170 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 participants at risk Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 participants at risk Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 participants at risk Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 participants at risk Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 participants at risk Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 participants at risk Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 participants at risk Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 participants at risk Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 participants at risk Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 participants at risk Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Infections and infestations Subcutaneous abscess	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Ankle fracture	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Chemical peritonitis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Staphylococcal infection	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Abdominal pain	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Colitis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Diarrhoea	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Dysphagia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Sepsis	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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
Blood and lymphatic system disorders Anaemia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Acute left ventricular failure	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Arteriosclerosis coronary artery	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 fibrillation	0.70% 2/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Atrioventricular block	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Bradycardia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 failure congestive	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 tamponade	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Cardio-respiratory arrest	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Left ventricular hypertrophy	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Myocardial ischaemia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Pericardial effusion	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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
Eye disorders Retinal detachment	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Food poisoning	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Gastric ulcer	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Gastritis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Hiatus hernia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Upper gastrointestinal haemorrhage	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Vomiting	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Chest pain	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Bile duct obstruction	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Cholecystitis acute	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Gallbladder pain	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Diverticulitis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Gangrene	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Septic shock	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Viral infection	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Wound sepsis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Contusion	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Extradural haematoma	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Femur fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Fractured sacrum	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Hip fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Joint dislocation	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Joint injury	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Multiple fractures	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 rupture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Pelvic fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Skeletal injury	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Spinal fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Stress fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Synovial rupture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Tendon rupture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Tibia fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 pressure increased	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Oxygen saturation decreased	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.70% 2/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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	1.2% 3/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Arthritis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 disorder	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 9/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Rotator cuff syndrome	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Spinal osteoarthritis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Spondylolisthesis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Synovial cyst	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Adenocarcinoma	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Breast cancer	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Endometrial cancer	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Gastric cancer	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Hepatic neoplasm malignant	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 carcinoma cell type unspecified stage IV	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Metastases to lung	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Metastases to spine	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Ovarian cancer	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Pancreatic carcinoma	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Prostate cancer	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Thyroid neoplasm	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Uterine cancer	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Aphasia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Cerebral ischaemia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Cerebrovascular accident	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Dizziness	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Ischaemic stroke	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Paralysis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Radiculopathy	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 VIIth nerve paralysis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Bronchitis chronic	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Dyspnoea	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Pneumonitis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Pneumothorax	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Pulmonary embolism	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Pulmonary oedema	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Aortic stenosis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Deep vein thrombosis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Right ventricular failure	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Ventricular tachycardia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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
Ear and labyrinth disorders Ear pain	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Enteritis	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 perforation	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Peptic ulcer perforation	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Arthritis bacterial	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Arthritis infective	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Bursitis infective	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Localised infection	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Osteomyelitis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 pneumococcal	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Foot fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Humerus fracture	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Incisional hernia	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Ligament rupture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Lower limb fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Lumbar vertebral fracture	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Subdural haematoma	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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
Metabolism and nutrition disorders Dehydration	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Bone disorder	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 degeneration	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Knee deformity	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Muscular weakness	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Spinal column stenosis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Synovitis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Central nervous system lymphoma	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 adenocarcinoma	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Renal cancer	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Uterine leiomyoma	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Cervical myelopathy	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Cervicobrachial syndrome	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Convulsion	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.36% 1/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Intracranial aneurysm	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Nerve root compression	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Transient ischaemic attack	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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
Renal and urinary disorders Calculus ureteric	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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
Renal and urinary disorders Renal failure acute	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Asthma	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Atelectasis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Hyperhidrosis	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Rash	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Peripheral ischaemia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Road traffic accident	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Lumbar spinal stenosis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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) Pituitary tumour benign	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Cholecystitis	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/285 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 7/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/283 Cases of osteonecrosis (ON) reported in this and other studies 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	1.2% 3/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/254 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/256 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 11/254 Cases of osteonecrosis (ON) reported in this and other studies 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	1.2% 3/256 Cases of osteonecrosis (ON) reported in this and other studies 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

Other adverse events
Measure	Tanezumab 5 mg (Naproxen Exposure) n=285 participants at risk Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Naproxen Exposure) n=288 participants at risk Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Naproxen 500 mg n=280 participants at risk Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Naproxen 500 mg n=288 participants at risk Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Naproxen 500 mg n=283 participants at risk Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.	Tanezumab 5 mg (Celecoxib Exposure) n=256 participants at risk Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 10 mg (Celecoxib Exposure) n=254 participants at risk Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.	Tanezumab 5 mg + Celecoxib 100 mg n=256 participants at risk Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Tanezumab 10 mg + Celecoxib 100 mg n=254 participants at risk Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.	Celecoxib 100 mg n=256 participants at risk Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Blood and lymphatic system disorders Anaemia	2.1% 6/285 Cases of osteonecrosis (ON) reported in this and other studies 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	1.0% 3/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 7/280 Cases of osteonecrosis (ON) reported in this and other studies 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	1.7% 5/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Abdominal pain upper	0.70% 2/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Diarrhoea	1.8% 5/285 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/280 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 10/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 7/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/256 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 11/254 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.9% 8/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.1% 3/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/254 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Fatigue	0.70% 2/285 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	5.3% 15/285 Cases of osteonecrosis (ON) reported in this and other studies 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	4.9% 14/288 Cases of osteonecrosis (ON) reported in this and other studies 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	7.1% 20/280 Cases of osteonecrosis (ON) reported in this and other studies 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	8.0% 23/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/283 Cases of osteonecrosis (ON) reported in this and other studies 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	7.0% 18/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/254 Cases of osteonecrosis (ON) reported in this and other studies 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	7.0% 18/256 Cases of osteonecrosis (ON) reported in this and other studies 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	10.6% 27/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/285 Cases of osteonecrosis (ON) reported in this and other studies 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	1.7% 5/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 6/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/285 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 7/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/280 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/283 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/254 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 6/254 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.5% 7/285 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 9/288 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 12/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 7/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/283 Cases of osteonecrosis (ON) reported in this and other studies 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	5.9% 15/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 10/254 Cases of osteonecrosis (ON) reported in this and other studies 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	7.0% 18/256 Cases of osteonecrosis (ON) reported in this and other studies 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	5.5% 14/254 Cases of osteonecrosis (ON) reported in this and other studies 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	5.9% 15/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/285 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/280 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 11/283 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 6/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 6/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 10/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.9% 11/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 11/288 Cases of osteonecrosis (ON) reported in this and other studies 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	5.0% 14/280 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 10/288 Cases of osteonecrosis (ON) reported in this and other studies 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	4.9% 14/283 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 11/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/254 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/254 Cases of osteonecrosis (ON) reported in this and other studies 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	6.2% 16/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.2% 9/285 Cases of osteonecrosis (ON) reported in this and other studies 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	4.9% 14/288 Cases of osteonecrosis (ON) reported in this and other studies 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	4.6% 13/280 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 9/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 16/283 Cases of osteonecrosis (ON) reported in this and other studies 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	8.2% 21/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/254 Cases of osteonecrosis (ON) reported in this and other studies 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	4.7% 12/256 Cases of osteonecrosis (ON) reported in this and other studies 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	5.9% 15/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/256 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/285 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 10/288 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 12/280 Cases of osteonecrosis (ON) reported in this and other studies 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	4.9% 14/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/254 Cases of osteonecrosis (ON) reported in this and other studies 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	4.7% 12/256 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 11/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Joint sprain	0.35% 1/285 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.1% 3/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.5% 7/285 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 10/288 Cases of osteonecrosis (ON) reported in this and other studies 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	4.6% 13/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 7/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 9/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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	11.2% 32/285 Cases of osteonecrosis (ON) reported in this and other studies 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	17.4% 50/288 Cases of osteonecrosis (ON) reported in this and other studies 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	13.2% 37/280 Cases of osteonecrosis (ON) reported in this and other studies 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	11.1% 32/288 Cases of osteonecrosis (ON) reported in this and other studies 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	9.2% 26/283 Cases of osteonecrosis (ON) reported in this and other studies 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	15.2% 39/256 Cases of osteonecrosis (ON) reported in this and other studies 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	15.4% 39/254 Cases of osteonecrosis (ON) reported in this and other studies 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	13.3% 34/256 Cases of osteonecrosis (ON) reported in this and other studies 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	10.6% 27/254 Cases of osteonecrosis (ON) reported in this and other studies 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	6.6% 17/256 Cases of osteonecrosis (ON) reported in this and other studies 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	5.6% 16/285 Cases of osteonecrosis (ON) reported in this and other studies 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	4.2% 12/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 9/280 Cases of osteonecrosis (ON) reported in this and other studies 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	4.2% 12/288 Cases of osteonecrosis (ON) reported in this and other studies 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	4.2% 12/283 Cases of osteonecrosis (ON) reported in this and other studies 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	5.9% 15/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/254 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 11/256 Cases of osteonecrosis (ON) reported in this and other studies 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	4.7% 12/254 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Joint effusion	0.70% 2/285 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.9% 8/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/254 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 7/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Joint swelling	2.8% 8/285 Cases of osteonecrosis (ON) reported in this and other studies 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	5.9% 17/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 9/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 11/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/283 Cases of osteonecrosis (ON) reported in this and other studies 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	5.5% 14/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 10/254 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 6/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.2% 9/285 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 9/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 7/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/254 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Musculoskeletal pain	3.5% 10/285 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 7/288 Cases of osteonecrosis (ON) reported in this and other studies 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	5.0% 14/280 Cases of osteonecrosis (ON) reported in this and other studies 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	1.7% 5/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 7/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 10/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 10/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 10/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Myalgia	1.8% 5/285 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 10/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.1% 3/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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	4.2% 12/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 11/288 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 12/280 Cases of osteonecrosis (ON) reported in this and other studies 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	4.9% 14/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 7/283 Cases of osteonecrosis (ON) reported in this and other studies 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	4.7% 12/256 Cases of osteonecrosis (ON) reported in this and other studies 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	6.3% 16/254 Cases of osteonecrosis (ON) reported in this and other studies 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	6.6% 17/256 Cases of osteonecrosis (ON) reported in this and other studies 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	4.7% 12/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.2% 9/285 Cases of osteonecrosis (ON) reported in this and other studies 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	7.6% 22/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 9/280 Cases of osteonecrosis (ON) reported in this and other studies 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	4.9% 14/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 7/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 10/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/254 Cases of osteonecrosis (ON) reported in this and other studies 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	4.7% 12/256 Cases of osteonecrosis (ON) reported in this and other studies 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	6.3% 16/254 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 11/256 Cases of osteonecrosis (ON) reported in this and other studies 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	1.1% 3/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 11/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.4% 4/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.1% 3/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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	4.7% 12/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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	1.2% 3/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Decreased vibratory sense	2.8% 8/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Dizziness	2.8% 8/285 Cases of osteonecrosis (ON) reported in this and other studies 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	1.7% 5/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 11/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.2% 9/285 Cases of osteonecrosis (ON) reported in this and other studies 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	6.2% 18/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 7/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 7/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/283 Cases of osteonecrosis (ON) reported in this and other studies 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	7.8% 20/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/254 Cases of osteonecrosis (ON) reported in this and other studies 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	5.9% 15/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/254 Cases of osteonecrosis (ON) reported in this and other studies 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	6.2% 16/256 Cases of osteonecrosis (ON) reported in this and other studies 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	5.6% 16/285 Cases of osteonecrosis (ON) reported in this and other studies 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	5.9% 17/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 16/280 Cases of osteonecrosis (ON) reported in this and other studies 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	5.9% 17/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 7/283 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/256 Cases of osteonecrosis (ON) reported in this and other studies 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	5.5% 14/254 Cases of osteonecrosis (ON) reported in this and other studies 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	7.4% 19/256 Cases of osteonecrosis (ON) reported in this and other studies 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	7.1% 18/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.7% 7/256 Cases of osteonecrosis (ON) reported in this and other studies 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	4.9% 14/285 Cases of osteonecrosis (ON) reported in this and other studies 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	9.7% 28/288 Cases of osteonecrosis (ON) reported in this and other studies 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	6.1% 17/280 Cases of osteonecrosis (ON) reported in this and other studies 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	12.2% 35/288 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/283 Cases of osteonecrosis (ON) reported in this and other studies 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	7.4% 19/256 Cases of osteonecrosis (ON) reported in this and other studies 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	4.3% 11/254 Cases of osteonecrosis (ON) reported in this and other studies 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	12.1% 31/256 Cases of osteonecrosis (ON) reported in this and other studies 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	9.8% 25/254 Cases of osteonecrosis (ON) reported in this and other studies 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	3.5% 9/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Anxiety	0.70% 2/285 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/280 Cases of osteonecrosis (ON) reported in this and other studies 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	1.0% 3/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.35% 1/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Insomnia	2.1% 6/285 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/280 Cases of osteonecrosis (ON) reported in this and other studies 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	0.69% 2/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 7/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/285 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 7/288 Cases of osteonecrosis (ON) reported in this and other studies 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	0.71% 2/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 8/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/283 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 6/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 10/256 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Rash	1.1% 3/285 Cases of osteonecrosis (ON) reported in this and other studies 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	1.7% 5/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 7/280 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/288 Cases of osteonecrosis (ON) reported in this and other studies 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	1.8% 5/283 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/256 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 6/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.1% 6/285 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 9/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 11/280 Cases of osteonecrosis (ON) reported in this and other studies 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	1.7% 5/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 9/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 7/254 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/256 Cases of osteonecrosis (ON) reported in this and other studies 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	3.1% 8/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 13/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Dyspepsia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Asthenia	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Joint injury	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	1.2% 3/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.8% 7/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Neck pain	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Rotator cuff syndrome	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.78% 2/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 6/254 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Burning sensation	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	1.2% 3/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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	1.6% 4/256 Cases of osteonecrosis (ON) reported in this and other studies 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	2.4% 6/254 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/256 Cases of osteonecrosis (ON) reported in this and other studies 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 Pruritus	0.00% 0/285 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/280 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/288 Cases of osteonecrosis (ON) reported in this and other studies 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% 0/283 Cases of osteonecrosis (ON) reported in this and other studies 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	1.2% 3/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.79% 2/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.0% 5/256 Cases of osteonecrosis (ON) reported in this and other studies 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	0.39% 1/254 Cases of osteonecrosis (ON) reported in this and other studies 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	2.3% 6/256 Cases of osteonecrosis (ON) reported in this and other studies 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

Additional Information

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