Trial Outcomes & Findings for Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement (NCT NCT02674386)

Last Updated: 2020-07-30

Results Overview

Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: "taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications." Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

154 participants

Primary outcome timeframe

Day 1

Results posted on

2020-07-30

Participant Flow

This study included participants from studies A4091056 (NCT02697773), A4091057 (NCT02709486) and A4091058 (NCT02528188) who had undergone a total joint replacement (TJR) surgery of knee, hip, or shoulder. During this study, if participant underwent an additional TJR surgery, then data for that additional TJR surgery was also assessed.

Pre-specified intent of this study was to compare results regardless of treatment group/doses in parent studies and also to report data for overall (combined participants from all parent studies).

Participant milestones

Participant milestones
Measure	Placebo Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined Participants who received tanezumab subcutaneous (SC) injection of 2.5 milligram (mg) or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID Participants who received non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
Overall Study STARTED	20	117	17
Overall Study Safety Analysis Set	20	113	17
Overall Study COMPLETED	20	107	16
Overall Study NOT COMPLETED	0	10	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanezumab Combined Participants who received tanezumab subcutaneous (SC) injection of 2.5 milligram (mg) or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID Participants who received non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	4	0
Overall Study Other	1	0
Overall Study Enrolled but not evaluated	4	0

Baseline Characteristics

Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=20 Participants Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 Participants Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=17 Participants Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	Total n=150 Participants Total of all reporting groups
Age, Continuous	65.26 Years STANDARD_DEVIATION 8.77 • n=5 Participants	64.57 Years STANDARD_DEVIATION 8.18 • n=7 Participants	62.94 Years STANDARD_DEVIATION 9.13 • n=5 Participants	64.47 Years STANDARD_DEVIATION 8.33 • n=4 Participants
Sex/Gender, Customized Male	6 Participants n=5 Participants	50 Participants n=7 Participants	4 Participants n=5 Participants	60 Participants n=4 Participants
Sex/Gender, Customized Female	13 Participants n=5 Participants	62 Participants n=7 Participants	13 Participants n=5 Participants	88 Participants n=4 Participants
Sex/Gender, Customized Unspecified	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	109 Participants n=7 Participants	14 Participants n=5 Participants	141 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	100 Participants n=7 Participants	14 Participants n=5 Participants	131 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Safety analysis set analyzed. Here, 'Overall number of participants analyzed (N)' = only those participants who had data available for this outcome measure (OM). 'Number analyzed (n)' = participants evaluable for this OM at specified categories.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=92 Participants Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=13 Participants Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=122 Participants All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Number of Participants With Surgeon's Assessment of Procedural Difficulty Knee · Minor Complications	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Surgeon's Assessment of Procedural Difficulty Knee · Major Complications	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Surgeon's Assessment of Procedural Difficulty Shoulder · Major Complications	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Surgeon's Assessment of Procedural Difficulty Knee · Uneventful	9 Participants	49 Participants	8 Participants	66 Participants
Number of Participants With Surgeon's Assessment of Procedural Difficulty Hip · Uneventful	8 Participants	37 Participants	4 Participants	49 Participants
Number of Participants With Surgeon's Assessment of Procedural Difficulty Hip · Minor Complications	0 Participants	4 Participants	0 Participants	4 Participants
Number of Participants With Surgeon's Assessment of Procedural Difficulty Hip · Major Complications	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Surgeon's Assessment of Procedural Difficulty Shoulder · Uneventful	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Surgeon's Assessment of Procedural Difficulty Shoulder · Minor Complications	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories.

SAPS contained four questions; How satisfied are you with the 1) results of your surgery 2) results of surgery for improving pain 3) results of surgery for improving ability to do home or yard work, and 4) results of surgery for improving your ability to do recreational activities. Items scored on a 4-point Likert scale with response of 'very satisfied' (100 points), 'somewhat satisfied' (75 points), 'somewhat dissatisfied' (50 points), and 'very dissatisfied' (25 points). The scale score calculated as mean of the scores of individual items, ranging from 25 to 100, with higher scores indicating greater satisfaction. Here, number of participants are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Participants may have been counted more than once if they had TJR surgery in more than one joint.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=99 Participants Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=13 Participants Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=131 Participants All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Knee: Satisfaction with result of surgery · Satisfied	9 Participants	53 Participants	5 Participants	67 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Knee: Satisfaction with result of surgery · Dissatisfied	0 Participants	5 Participants	1 Participants	6 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Knee: Results of surgery for relieving pain · Satisfied	9 Participants	52 Participants	5 Participants	66 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Knee: Results of surgery for relieving pain · Dissatisfied	0 Participants	6 Participants	1 Participants	7 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Knee: Improving ability-recreational activities · Dissatisfied	0 Participants	8 Participants	1 Participants	9 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Hip: Satisfaction with result of surgery · Dissatisfied	1 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Hip: Improving ability for home or yard work · Satisfied	9 Participants	41 Participants	6 Participants	56 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Hip: Improving ability for home or yard work · Dissatisfied	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Hip: Improving ability-recreational activities · Satisfied	9 Participants	40 Participants	6 Participants	55 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Hip: Improving ability-recreational activities · Dissatisfied	1 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Shoulder: Satisfaction with result of surgery · Satisfied	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Shoulder: Satisfaction with result of surgery · Dissatisfied	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Shoulder: Results of surgery for relieving pain · Satisfied	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Knee: Improving ability-recreational activities · Satisfied	9 Participants	50 Participants	5 Participants	64 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Knee: Improving ability for home or yard work · Dissatisfied	0 Participants	10 Participants	1 Participants	11 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Knee: Improving ability for home or yard work · Satisfied	9 Participants	48 Participants	5 Participants	62 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Hip: Results of surgery for relieving pain · Satisfied	9 Participants	41 Participants	6 Participants	56 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Hip: Results of surgery for relieving pain · Dissatisfied	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Shoulder: Results of surgery for relieving pain · Dissatisfied	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Shoulder: Improving ability for home or yard work · Satisfied	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Shoulder: Improving ability for home or yard work · Dissatisfied	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Shoulder:Improving ability-recreational activities · Satisfied	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Shoulder:Improving ability-recreational activities · Dissatisfied	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Hip: Satisfaction with result of surgery · Satisfied	9 Participants	40 Participants	6 Participants	55 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 24

Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories.

Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Participants may have been counted more than once if they had TJR surgery in more than one joint.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 Participants Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=17 Participants Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=150 Participants All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Number of Participants With Post-Surgical Complications Upto Week 24 Knee	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Post-Surgical Complications Upto Week 24 Hip	0 Participants	5 Participants	0 Participants	5 Participants
Number of Participants With Post-Surgical Complications Upto Week 24 Shoulder	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 24

Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories.

Participants were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Participants, who responded as yes have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 Participants Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=17 Participants Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=150 Participants All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 Knee	0 Participants	4 Participants	0 Participants	4 Participants
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 Hip	0 Participants	5 Participants	1 Participants	6 Participants
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 Shoulder	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 24

Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories.

Participants responded with a yes or no to the following question ''are you participating in physical rehabilitation activities related to your replaced joint''. Participants responded with a yes, have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 Participants Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=17 Participants Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=150 Participants All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 Knee	10 Participants	55 Participants	7 Participants	72 Participants
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 Hip	9 Participants	33 Participants	3 Participants	45 Participants
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 Shoulder	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'n' = participants evaluable for this OM at specified categories.

Participants assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.

Outcome measures

Outcome measures
Measure	Placebo n=20 total joint replacements Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 total joint replacements Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=17 total joint replacements Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=150 total joint replacements All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 Baseline: Knee	6.00 units on a scale Standard Deviation 2.31	6.86 units on a scale Standard Deviation 2.14	6.80 units on a scale Standard Deviation 2.20	6.76 units on a scale Standard Deviation 2.16
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 Baseline: Hip	6.10 units on a scale Standard Deviation 2.13	6.81 units on a scale Standard Deviation 2.27	5.86 units on a scale Standard Deviation 3.44	6.60 units on a scale Standard Deviation 2.38
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 Change at Week 24: Knee	-4.56 units on a scale Standard Deviation 1.24	-5.32 units on a scale Standard Deviation 2.63	-5.43 units on a scale Standard Deviation 2.51	-5.24 units on a scale Standard Deviation 2.49
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 Change at Week 24: Hip	-5.20 units on a scale Standard Deviation 2.30	-5.67 units on a scale Standard Deviation 2.37	-5.00 units on a scale Standard Deviation 4.10	-5.52 units on a scale Standard Deviation 2.53

PRIMARY outcome

Timeframe: Baseline, Week 24

WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.

Outcome measures

Outcome measures
Measure	Placebo n=20 total joint replacements Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 total joint replacements Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=15 total joint replacements Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=148 total joint replacements All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 Baseline: Hip	4.80 units on a scale Standard Deviation 2.61	5.97 units on a scale Standard Deviation 2.46	6.13 units on a scale Standard Deviation 1.98	5.80 units on a scale Standard Deviation 2.45
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 Baseline: Knee	4.66 units on a scale Standard Deviation 3.05	5.62 units on a scale Standard Deviation 2.33	6.11 units on a scale Standard Deviation 2.31	5.56 units on a scale Standard Deviation 2.41
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 Change at Week 24: Knee	-3.13 units on a scale Standard Deviation 1.74	-4.50 units on a scale Standard Deviation 2.43	-4.54 units on a scale Standard Deviation 3.15	-4.34 units on a scale Standard Deviation 2.44
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 Change at Week 24: Hip	-4.34 units on a scale Standard Deviation 2.52	-4.92 units on a scale Standard Deviation 2.62	-5.92 units on a scale Standard Deviation 2.40	-4.91 units on a scale Standard Deviation 2.57

PRIMARY outcome

Timeframe: Baseline, Week 24

WOMAC: self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the replaced/to be replaced index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.

Outcome measures

Outcome measures
Measure	Placebo n=20 total joint replacements Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 total joint replacements Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=15 total joint replacements Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=148 total joint replacements All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 Baseline: Hip	4.70 units on a scale Standard Deviation 2.75	5.96 units on a scale Standard Deviation 2.69	5.25 units on a scale Standard Deviation 3.50	5.69 units on a scale Standard Deviation 2.77
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 Change at Week 24: Knee	-1.78 units on a scale Standard Deviation 1.52	-4.13 units on a scale Standard Deviation 2.58	-3.43 units on a scale Standard Deviation 3.13	-3.79 units on a scale Standard Deviation 2.62
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 Change at Week 24: Hip	-4.00 units on a scale Standard Deviation 2.66	-4.48 units on a scale Standard Deviation 2.87	-3.80 units on a scale Standard Deviation 3.70	-4.33 units on a scale Standard Deviation 2.86
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 Baseline: Knee	4.80 units on a scale Standard Deviation 2.78	5.75 units on a scale Standard Deviation 2.52	6.44 units on a scale Standard Deviation 2.58	5.71 units on a scale Standard Deviation 2.55

PRIMARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Outcome measures
Measure	Placebo n=20 total joint replacements Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 total joint replacements Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=15 total joint replacements Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=148 total joint replacements All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 Baseline: Knee	4.83 units on a scale Standard Deviation 2.99	5.82 units on a scale Standard Deviation 2.11	6.63 units on a scale Standard Deviation 1.98	5.79 units on a scale Standard Deviation 2.23
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 Baseline: Hip	5.56 units on a scale Standard Deviation 2.21	6.50 units on a scale Standard Deviation 2.22	6.86 units on a scale Standard Deviation 1.48	6.38 units on a scale Standard Deviation 2.17
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 Change at Week 24: Knee	-2.69 units on a scale Standard Deviation 1.51	-4.42 units on a scale Standard Deviation 2.19	-4.59 units on a scale Standard Deviation 2.90	-4.24 units on a scale Standard Deviation 2.24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 Change at Week 24: Hip	-4.64 units on a scale Standard Deviation 2.13	-5.05 units on a scale Standard Deviation 2.44	-5.95 units on a scale Standard Deviation 1.84	-5.06 units on a scale Standard Deviation 2.33

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Enrolled participants who received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had qualifying shoulder replacement. "N"=those participants who had data available for this OM, hence data for Placebo and Tanezumab reporting groups were not collected as no participants were evaluable for this OM.

SPADI: self-administered questionnaire to measure pain and disability associated with shoulder pathology in participants with shoulder pain. It consists of two dimensions pain and function. Pain dimension:5 questions regarding severity of pain, scores ranged from 0=no pain to 10=worst pain imaginable, higher scores indicated extreme pain. Functional activities:8 questions to measure degree of difficulty with various activities of daily living that require upper extremity use, scores ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as the sum of non-missing scores divided by the maximum possible score (50 \[for pain\] and 80 \[for disability\]) multiplied by 100. A total score was calculated as the mean of two dimensions, ranged from 0=best to 100=worst, higher scores indicated worsening of condition.

Outcome measures

Outcome measures
Measure	Placebo Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=1 total joint replacements Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=1 total joint replacements All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 Baseline	—	—	89.88 units on a scale	89.88 units on a scale
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 Change at Week 24	—	—	-89.88 units on a scale	-89.88 units on a scale

PRIMARY outcome

Timeframe: Baseline up to Week 24

Population: Safety analysis set: all enrolled participants of this study who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 Participants Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=17 Participants Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=150 Participants All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Number of Participants Who Used Concomitant Analgesic Medications	18 Participants	100 Participants	15 Participants	133 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tanezumab 2.5 mg

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Tanezumab 2.5/5 mg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Tanezumab 5 mg

Serious events: 7 serious events

Other events: 9 other events

Deaths: 0 deaths

Tanezumab Combined

Serious events: 15 serious events

Other events: 21 other events

Deaths: 0 deaths

NSAID

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

All Participants

Serious events: 17 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=20 participants at risk Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab 2.5 mg n=52 participants at risk Participants who received tanezumab 2.5 mg SC injection in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	Tanezumab 2.5/5 mg n=8 participants at risk Participants who received tanezumab 2.5/5 mg SC injection in study A4091056 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	Tanezumab 5 mg n=53 participants at risk Participants who received tanezumab 5 mg SC injection in studies A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 participants at risk Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=17 participants at risk Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=150 participants at risk All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Infections and infestations Device related infection	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Infections and infestations Gastroenteritis viral	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	12.5% 1/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Cardiac disorders Coronary artery occlusion	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	12.5% 1/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Gastrointestinal disorders Enteritis	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Gastrointestinal disorders Hiatus hernia	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	12.5% 1/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Hepatobiliary disorders Cholecystitis	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Infections and infestations Pneumonia	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Infections and infestations Post procedural infection	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	3.8% 2/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	2.7% 3/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	11.8% 2/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	3.3% 5/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	12.5% 1/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Nervous system disorders Parkinson's disease	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Product Issues Device dislocation	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Psychiatric disorders Hallucination	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Vascular disorders Deep vein thrombosis	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Vascular disorders Haematoma	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.

Other adverse events

Other adverse events
Measure	Placebo n=20 participants at risk Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.	Tanezumab 2.5 mg n=52 participants at risk Participants who received tanezumab 2.5 mg SC injection in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	Tanezumab 2.5/5 mg n=8 participants at risk Participants who received tanezumab 2.5/5 mg SC injection in study A4091056 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	Tanezumab 5 mg n=53 participants at risk Participants who received tanezumab 5 mg SC injection in studies A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	Tanezumab Combined n=113 participants at risk Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	NSAID n=17 participants at risk Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.	All Participants n=150 participants at risk All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Cardiac disorders Atrioventricular block second degree	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.9% 1/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Cardiac disorders Coronary artery stenosis	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.9% 1/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
General disorders Chest pain	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.9% 1/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
General disorders Peripheral swelling	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.9% 1/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Immune system disorders Drug hypersensitivity	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.9% 1/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.8% 3/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	11.3% 6/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	8.0% 9/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	6.0% 9/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	12.5% 1/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	3.8% 2/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	2.7% 3/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	2.0% 3/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.9% 1/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.3% 2/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.8% 3/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	2.7% 3/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	2.0% 3/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	12.5% 1/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.8% 2/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.3% 2/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.88% 1/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.9% 1/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.3% 2/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Renal and urinary disorders Urinary retention	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	12.5% 1/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.9% 1/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.8% 2/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	1.3% 2/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
Vascular disorders Deep vein thrombosis	0.00% 0/20 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/52 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/8 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/53 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.00% 0/113 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	5.9% 1/17 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.	0.67% 1/150 • Baseline up to Week 24 Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.

Additional Information

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Results disclosure agreements

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