Trial Outcomes & Findings for Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain (NCT NCT02725411)

NCT ID: NCT02725411

Last Updated: 2020-08-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 277 participants
• Primary outcome timeframe: Baseline up to Week 80
• Results posted on: 2020-08-11

Participant Flow

Participant milestones

Measure	Tanezumab 5 mg Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Treatment Period (56 Weeks) STARTED	92	93	92
Treatment Period (56 Weeks) Treated	92	93	92
Treatment Period (56 Weeks) COMPLETED	62	43	43
Treatment Period (56 Weeks) NOT COMPLETED	30	50	49
Follow-up Period (24 Weeks) STARTED	92	93	92
Follow-up Period (24 Weeks) COMPLETED	88	82	87
Follow-up Period (24 Weeks) NOT COMPLETED	4	11	5

Reasons for withdrawal

Measure	Tanezumab 5 mg Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Treatment Period (56 Weeks) Adverse Event	3	5	4
Treatment Period (56 Weeks) Lack of Efficacy	1	4	1
Treatment Period (56 Weeks) Lost to Follow-up	0	1	0
Treatment Period (56 Weeks) Other	1	4	5
Treatment Period (56 Weeks) Withdrawal by Subject	0	1	4
Treatment Period (56 Weeks) Not Met Protocol-Specified Criteria	25	35	35
Follow-up Period (24 Weeks) Adverse Event	1	1	0
Follow-up Period (24 Weeks) Lack of Efficacy	0	2	0
Follow-up Period (24 Weeks) Lost to Follow-up	1	1	0
Follow-up Period (24 Weeks) Other	1	4	2
Follow-up Period (24 Weeks) Withdrawal by Subject	1	3	3

Baseline Characteristics

Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain

Baseline characteristics by cohort

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Total n=277 Participants Total of all reporting groups
Age, Continuous	53.35 Years STANDARD_DEVIATION 12.97 • n=5 Participants	52.32 Years STANDARD_DEVIATION 14.02 • n=7 Participants	54.34 Years STANDARD_DEVIATION 14.21 • n=5 Participants	53.33 Years STANDARD_DEVIATION 13.72 • n=4 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	44 Participants n=7 Participants	38 Participants n=5 Participants	119 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	49 Participants n=7 Participants	54 Participants n=5 Participants	158 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	92 Participants n=5 Participants	93 Participants n=7 Participants	92 Participants n=5 Participants	277 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 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	92 Participants n=5 Participants	93 Participants n=7 Participants	92 Participants n=5 Participants	277 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	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to 24 weeks after last dose of study drug (up to Week 80)

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 24 weeks after last dose of study drug (up to Week 80) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with SAEs	8 Participants	11 Participants	4 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with AEs	70 Participants	63 Participants	67 Participants

PRIMARY outcome

Timeframe: Baseline up to 24 weeks after last dose of study drug (up to Week 80)

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 24 weeks after last dose of study drug (up to Week 80). Relatedness to study drug was assessed by the investigator. AEs included both serious and non-serious AEs.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with treatment related AEs	11 Participants	7 Participants	12 Participants
Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with treatment related SAEs	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

Abnormality criteria included: hemoglobin (HGB); hematocrit; erythrocytes < 0.8*lower limit of normal (LLN); erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*upper limit of normal (ULN); platelets <0.5*LLN,>1.75* ULN; white blood cell count<0.6*LLN, >1.5*ULN; lymphocytes, leukocytes, neutrophils <0.8*LLN, >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, cholesterol, triglycerides >1.3*ULN; urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase >2.0*ULN; nitrite >=1. Investigator judged clinical significance of laboratory test abnormalities.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants With Clinically Significant Laboratory Test Abnormalities	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate. Investigator judged clinical significance of vital signs' abnormalities.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants With Clinically Significant Vital Signs Abnormalities	4 Participants	2 Participants	5 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

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

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants With Confirmed Orthostatic Hypotension From Baseline up to Week 80	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Screening (up to 37 days before Day 1), Week 24

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

SAS is a participant rated 12 items questionnaire for males and 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during the past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants were asked to answer "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If a participant answered "Yes" for a symptom, then impact of that symptom was rated on a 5 point scale, ranged from 1 (least sever impact) to 5 (most severe impact), where higher scores signified more severe impact of symptoms. The total symptom impact score was calculated as the sum of impact of all symptoms. Overall possible range for the total symptom impact score was 0 (no impact) to 60 (extreme impact) for males and 0 (no impact) to 55 (extreme impact) for females, higher scores indicated more severe impact of symptoms on participants' well-being.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Week 24 Change at Week 24	0.79 units on a scale Standard Deviation 2.29	0.93 units on a scale Standard Deviation 3.36	0.04 units on a scale Standard Deviation 2.66
Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Week 24 Screening	0.76 units on a scale Standard Deviation 1.51	0.86 units on a scale Standard Deviation 1.58	1.10 units on a scale Standard Deviation 1.78

PRIMARY outcome

Timeframe: Screening, Week 56

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, "Overall number of participants analyzed" signifies only those participants who were evaluable for this outcome measure.

SAS is a participant rated 12 items questionnaire for males and 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during the past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants were asked to answer "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If a participant answered "Yes" for a symptom, then impact of that symptom was rated on a 5 point scale, ranged from 1 (least sever impact) to 5 (most severe impact), where higher scores signified more severe impact of symptoms. The total symptom impact score was calculated as the sum of impact of all symptoms. Overall possible range for the total symptom impact score was 0 (no impact) to 60 (extreme impact) for males and 0 (no impact) to 55 (extreme impact) for females, higher scores indicated more severe impact of symptoms on participants' well-being.

Outcome measures

Measure	Tanezumab 5 mg n=62 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=43 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=43 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Week 56	0.89 units on a scale Standard Deviation 3.30	0.86 units on a scale Standard Deviation 4.10	0.35 units on a scale Standard Deviation 2.60

PRIMARY outcome

Timeframe: Screening, Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, "Overall number of participants analyzed" signifies only those participants who were evaluable for this outcome measure.

SAS is a participant rated 12 items questionnaire for males and 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during the past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants were asked to answer "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If a participant answered "Yes" for a symptom, then impact of that symptom was rated on a 5 point scale, ranged from 1 (least sever impact) to 5 (most severe impact), where higher scores signified more severe impact of symptoms. The total symptom impact score was calculated as the sum of impact of all symptoms. Overall possible range for the total symptom impact score was 0 (no impact) to 60 (extreme impact) for males and 0 (no impact) to 55 (extreme impact) for females, higher scores indicated more severe impact of symptoms on participants' well-being.

Outcome measures

Measure	Tanezumab 5 mg n=62 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=43 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=43 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Screening in Mean Total Symptom Impact Scores as Per Survey of Autonomic Symptoms (SAS) at Week 80	0.69 units on a scale Standard Deviation 2.81	1.26 units on a scale Standard Deviation 3.29	0.72 units on a scale Standard Deviation 3.17

PRIMARY outcome

Timeframe: Screening, Early Termination Follow-up Visit 1 (at 8 weeks after last dose of tanezumab or placebo matched to tanezumab)

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, "Overall number of participants analyzed" signifies only those participants who were evaluable for this outcome measure.

SAS: participant rated 12 items questionnaire for males; 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants answered "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If participant answered "Yes" for a symptom, then impact of that symptom was rated on 5 point scale (1 [least sever impact] to 5 [most severe impact]); higher scores = more severe impact of symptoms. Total impact score = sum of impact of all symptoms; range for males =0 (no impact) to 60 (extreme impact); females =0 (no impact) to 55 (extreme impact); higher scores = more severe impact of symptoms on participants' well-being. Participants discontinuing from study treatment before Week 56, had early termination follow-up visit 1 at 8 weeks after last dose of tanezumab or placebo matched to tanezumab.

Outcome measures

Measure	Tanezumab 5 mg n=30 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=49 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=48 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Early Termination Follow-up Visit 1	2.50 units on a scale Standard Deviation 5.28	0.82 units on a scale Standard Deviation 3.42	2.15 units on a scale Standard Deviation 3.94

PRIMARY outcome

Timeframe: Screening, Early Termination Follow-up Visit 3 (at 24 weeks after last dose of tanezumab or placebo matched to tanezumab)

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, "Overall number of participants analyzed" signifies only those participants who were evaluable for this outcome measure.

SAS: participant rated 12 items questionnaire for males; 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants answered "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If participant answered "Yes" for a symptom, then impact of that symptom was rated on 5 point scale (1 [least sever impact] to 5 [most severe impact]); higher scores = more severe impact of symptoms. Total impact score = sum of impact of all symptoms; range for males =0 (no impact) to 60 (extreme impact); females =0 (no impact) to 55 (extreme impact); higher scores = more severe impact of symptoms on participants' well-being. Participants discontinuing from study treatment before Week 56, had early termination follow-up visit 3 at 24 weeks after last dose of tanezumab or placebo matched to tanezumab.

Outcome measures

Measure	Tanezumab 5 mg n=27 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=45 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=43 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Screening in Mean Total Symptom Impact Scores as Per Survey of Autonomic Symptoms (SAS) at Early Termination Follow-up Visit 3	1.89 units on a scale Standard Deviation 5.57	1.60 units on a scale Standard Deviation 3.82	0.88 units on a scale Standard Deviation 3.03

PRIMARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

Electrocardiogram assessment included PR, QRS, QT, QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), RR intervals, and heart rate. Investigator judged clinical significance of electrocardiogram assessment.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants With Clinically Significant Electrocardiogram (ECG) Assessments	2 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

Percentage of participants with individual joint safety adjudication outcomes: rapidly progressive osteoarthritis (OA) type-1 only, rapidly progressive OA type-2 only, primary osteonecrosis, pathological fracture and subchondral insufficiency fracture is reported. Rapidly progressive (RP) OA type 1 events were those that the adjudication committee considered to have significant loss of joint space width >= 2 millimeter within approximately 1 year without gross structural failure. RP OA type 2 events were those considered to have destruction of bone including limited or total collapse of at least 1 subchondral surface that is not normally present in conventional end-stage osteoarthritis. Subchondral insufficiency fractures are a type of stress fractures which occur below the cartilage on the weight bearing surface of a bone.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Percentage of Participants With Individual Adjudicated Joint Safety Outcome/Event Pathological Fracture	0 percentage of participants Interval 0.0 to 3.9	0 percentage of participants Interval 0.0 to 3.9	0 percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Individual Adjudicated Joint Safety Outcome/Event Rapidly Progressive OA type 1	1 percentage of participants Interval 0.0 to 5.9	0 percentage of participants Interval 0.0 to 3.9	0 percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Individual Adjudicated Joint Safety Outcome/Event Rapidly Progressive OA type 2	0 percentage of participants Interval 0.0 to 3.9	1 percentage of participants Interval 0.0 to 5.8	0 percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Individual Adjudicated Joint Safety Outcome/Event Primary Osteonecrosis	0 percentage of participants Interval 0.0 to 3.9	0 percentage of participants Interval 0.0 to 3.9	0 percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Individual Adjudicated Joint Safety Outcome/Event Subchondral Insufficiency Fracture	0 percentage of participants Interval 0.0 to 3.9	1 percentage of participants Interval 0.0 to 5.8	0 percentage of participants Interval 0.0 to 3.9

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

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

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Observation Time-Adjusted Event Rate for an Individual Adjudicated Joint Safety Outcome/Event Rapidly Progressive OA Type 1	8.9 events per 1000 participant-years Interval 1.2 to 62.9	0 events per 1000 participant-years Interval 0.0 to 0.0	0 events per 1000 participant-years Interval 0.0 to 0.0
Observation Time-Adjusted Event Rate for an Individual Adjudicated Joint Safety Outcome/Event Rapidly Progressive OA Type 2	0 events per 1000 participant-years Interval 0.0 to 0.0	10.4 events per 1000 participant-years Interval 1.5 to 74.1	0 events per 1000 participant-years Interval 0.0 to 0.0
Observation Time-Adjusted Event Rate for an Individual Adjudicated Joint Safety Outcome/Event Primary Osteonecrosis	0 events per 1000 participant-years Interval 0.0 to 0.0	0 events per 1000 participant-years Interval 0.0 to 0.0	0 events per 1000 participant-years Interval 0.0 to 0.0
Observation Time-Adjusted Event Rate for an Individual Adjudicated Joint Safety Outcome/Event Pathological Fracture	0 events per 1000 participant-years Interval 0.0 to 0.0	0 events per 1000 participant-years Interval 0.0 to 0.0	0 events per 1000 participant-years Interval 0.0 to 0.0
Observation Time-Adjusted Event Rate for an Individual Adjudicated Joint Safety Outcome/Event Subchondral Insufficiency Fracture	0 events per 1000 participant-years Interval 0.0 to 0.0	10.5 events per 1000 participant-years Interval 1.5 to 74.6	0 events per 1000 participant-years Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

Percentage of participants with at least 1 total knee, total hip or total shoulder joint replacement were reported.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Percentage of Participants With At Least 1 Total Joint Replacement	0 percentage of participants Interval 0.0 to 3.9	1 percentage of participants Interval 0.0 to 5.8	0 percentage of participants Interval 0.0 to 3.9

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant had no TJR, or (ii) date of TJR (earliest TJR within each participant in the case of multiple TJRs). Event rate = number of events per 1000 participant-years at risk.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Observation Time-Adjusted Event Rate for Total Joint Replacement (TJR) Event	0 events per 1000 participant-years Interval 0.0 to 0.0	10.4 events per 1000 participant-years Interval 1.5 to 74.1	0 events per 1000 participant-years Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Baseline, Week 2

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 Baseline	0.84 units on a scale Standard Deviation 2.39	1.01 units on a scale Standard Deviation 4.06	0.87 units on a scale Standard Deviation 2.19
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 Change at Week 2	-0.04 units on a scale Standard Deviation 0.25	-0.01 units on a scale Standard Deviation 0.48	0.11 units on a scale Standard Deviation 1.19

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4	-0.08 units on a scale Standard Deviation 0.50	-0.02 units on a scale Standard Deviation 0.68	0.11 units on a scale Standard Deviation 1.08

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8	-0.04 units on a scale Standard Deviation 0.39	0.15 units on a scale Standard Deviation 0.78	0.13 units on a scale Standard Deviation 0.99

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16	-0.02 units on a scale Standard Deviation 0.21	0.05 units on a scale Standard Deviation 0.71	0.01 units on a scale Standard Deviation 0.87

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24	-0.02 units on a scale Standard Deviation 0.21	0.09 units on a scale Standard Deviation 0.70	0.28 units on a scale Standard Deviation 1.83

PRIMARY outcome

Timeframe: Baseline, Week 32

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32	0.00 units on a scale Standard Deviation 0.36	-0.01 units on a scale Standard Deviation 0.96	0.04 units on a scale Standard Deviation 1.64

PRIMARY outcome

Timeframe: Baseline, Week 40

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40	0.14 units on a scale Standard Deviation 1.14	0.04 units on a scale Standard Deviation 1.03	0.04 units on a scale Standard Deviation 1.64

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48	0.09 units on a scale Standard Deviation 1.09	-0.01 units on a scale Standard Deviation 0.97	0.04 units on a scale Standard Deviation 1.70

PRIMARY outcome

Timeframe: Baseline, Week 56

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 56	0.09 units on a scale Standard Deviation 1.09	-0.02 units on a scale Standard Deviation 0.97	0.04 units on a scale Standard Deviation 1.64

PRIMARY outcome

Timeframe: Baseline, Week 64

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 64	0.18 units on a scale Standard Deviation 1.43	0.01 units on a scale Standard Deviation 0.98	0.04 units on a scale Standard Deviation 1.70

PRIMARY outcome

Timeframe: Baseline, Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 80	0.03 units on a scale Standard Deviation 1.26	0.00 units on a scale Standard Deviation 0.97	0.17 units on a scale Standard Deviation 2.36

PRIMARY outcome

Timeframe: Baseline to any post-baseline visit (until Week 80)

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. Largest change from baseline here means worst post- baseline change value (among all change from baseline values).

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Largest Change From Baseline in Neuropathy Impairment Score (NIS) to Any Post-baseline Visit	0.33 units on a scale Standard Deviation 1.47	0.37 units on a scale Standard Deviation 1.06	0.78 units on a scale Standard Deviation 2.62

PRIMARY outcome

Timeframe: Baseline up to Week 80

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a validated analytical method. Number of participants with presence of anti-tanezumab antibodies are reported.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants With Anti Tanezumab Antibodies From Baseline up to Week 80	21 Participants	41 Participants	62 Participants

PRIMARY outcome

Timeframe: At Screening

Population: Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.

Physical examination included assessment of general appearance, skin, head, neck, eyes, ears, nose, throat, abdomen, lungs, heart, thyroid, and extremities. Investigator judged abnormality in physical examinations. Only those rows have been reported which had at least 1 participant with abnormality data in any of the reporting arms.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants With Abnormal Physical Examination Findings Nose	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Physical Examination Findings Extremities	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Physical Examination Findings Heart	2 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Physical Examination Findings Ear	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Physical Examination Findings Skin	1 Participants	0 Participants	3 Participants
Number of Participants With Abnormal Physical Examination Findings Neck	2 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Physical Examination Findings Eyes	1 Participants	1 Participants	1 Participants

SECONDARY outcome

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

Population: Intent to treat (ITT) population included all randomized participants who received at least 1 dose of SC study medication (either tanezumab or placebo matched to tanezumab). Missing data were imputed with multiple imputation method based on the reason for missing data.

Average LBPI was assessed on an 11-point numeric rating scale (NRS). Participants described their average LBPI during the past 24 hours (at each specified/scheduled time-point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 2	-0.47 units on a scale Standard Error 0.14	-0.69 units on a scale Standard Error 0.14	-0.46 units on a scale Standard Error 0.14
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 4	-0.83 units on a scale Standard Error 0.17	-1.05 units on a scale Standard Error 0.17	-0.56 units on a scale Standard Error 0.17
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 8	-1.24 units on a scale Standard Error 0.20	-1.64 units on a scale Standard Error 0.20	-1.07 units on a scale Standard Error 0.20
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 12	-2.19 units on a scale Standard Error 0.23	-2.46 units on a scale Standard Error 0.23	-1.85 units on a scale Standard Error 0.23
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 16	-2.91 units on a scale Standard Error 0.23	-2.51 units on a scale Standard Error 0.23	-2.28 units on a scale Standard Error 0.23
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 24	-2.88 units on a scale Standard Error 0.28	-2.41 units on a scale Standard Error 0.28	-2.11 units on a scale Standard Error 0.29
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 32	-2.95 units on a scale Standard Error 0.29	-2.34 units on a scale Standard Error 0.30	-2.08 units on a scale Standard Error 0.30
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 40	-3.00 units on a scale Standard Error 0.30	-2.32 units on a scale Standard Error 0.30	-2.06 units on a scale Standard Error 0.29
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 48	-3.07 units on a scale Standard Error 0.30	-2.31 units on a scale Standard Error 0.31	-2.09 units on a scale Standard Error 0.31
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 56	-2.98 units on a scale Standard Error 0.29	-2.22 units on a scale Standard Error 0.30	-2.13 units on a scale Standard Error 0.30

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: ITT population analyzed. ''Overall number of participants analyzed'' = participants who were evaluable for this outcome measure. Observed data: analysis was performed using all available data at Week 64, and no imputation technique was used for missing data.

Average LBPI was assessed on an 11-point NRS. Participants described their average LBPI during the past 24 hours (at each specified/scheduled time-point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain.

Outcome measures

Measure	Tanezumab 5 mg n=61 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=43 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=43 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Average Low Back Pain Intensity (LBPI) at Week 64: Observed Data	-3.60 units on a scale Standard Deviation 1.81	-3.96 units on a scale Standard Deviation 1.82	-3.46 units on a scale Standard Deviation 1.89

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Missing data were imputed with multiple imputation method based on the reason for missing data.

The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. Participants were asked to check/select only those items out of 24 items, which described them at each specified time point. The total number of items checked in questionnaire was equal to RMDQ total score, overall possible score ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater/more disability.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 32	-3.62 units on a scale Standard Error 0.48	-3.11 units on a scale Standard Error 0.49	-3.02 units on a scale Standard Error 0.49
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 56	-3.95 units on a scale Standard Error 0.49	-2.91 units on a scale Standard Error 0.50	-2.94 units on a scale Standard Error 0.50
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 2	-2.09 units on a scale Standard Error 0.34	-2.09 units on a scale Standard Error 0.34	-1.23 units on a scale Standard Error 0.34
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 4	-2.41 units on a scale Standard Error 0.40	-2.35 units on a scale Standard Error 0.40	-1.89 units on a scale Standard Error 0.39
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 8	-2.74 units on a scale Standard Error 0.39	-3.23 units on a scale Standard Error 0.39	-2.68 units on a scale Standard Error 0.39
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 16	-3.85 units on a scale Standard Error 0.41	-4.38 units on a scale Standard Error 0.42	-3.84 units on a scale Standard Error 0.42
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 24	-3.58 units on a scale Standard Error 0.48	-3.32 units on a scale Standard Error 0.47	-3.16 units on a scale Standard Error 0.48
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 40	-3.98 units on a scale Standard Error 0.50	-2.95 units on a scale Standard Error 0.50	-2.90 units on a scale Standard Error 0.51
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation Change at Week 48	-3.99 units on a scale Standard Error 0.48	-2.96 units on a scale Standard Error 0.51	-3.19 units on a scale Standard Error 0.50

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: ITT population analyzed. "Overall number of participants analyzed" = participants who were evaluable for this outcome measure. Observed data: analysis was performed using all available data at Week 64 and no imputation technique was used for missing data.

The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. Participants were asked to check/select only those items out of 24 items, which described them at each specified time point. The total number of items checked in questionnaire was equal to RMDQ total score, overall possible score ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater/more disability.

Outcome measures

Measure	Tanezumab 5 mg n=62 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=43 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=43 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 64: Observed Data	-4.55 units on a scale Standard Deviation 4.04	-5.72 units on a scale Standard Deviation 4.61	-5.02 units on a scale Standard Deviation 3.96

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

PGA of low back pain was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1 to 5, using interactive response technology (IRT), where 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 48	-1.21 units on a scale Standard Deviation 0.70	-1.11 units on a scale Standard Deviation 0.57	-1.02 units on a scale Standard Deviation 0.66
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 56	-1.13 units on a scale Standard Deviation 0.68	-1.14 units on a scale Standard Deviation 0.56	-1.07 units on a scale Standard Deviation 0.59
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 64	-0.94 units on a scale Standard Deviation 0.72	-0.84 units on a scale Standard Deviation 0.61	-0.86 units on a scale Standard Deviation 0.71
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Baseline	3.24 units on a scale Standard Deviation 0.45	3.14 units on a scale Standard Deviation 0.38	3.13 units on a scale Standard Deviation 0.34
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 2	-0.43 units on a scale Standard Deviation 0.63	-0.40 units on a scale Standard Deviation 0.63	-0.28 units on a scale Standard Deviation 0.52
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 4	-0.48 units on a scale Standard Deviation 0.72	-0.46 units on a scale Standard Deviation 0.73	-0.37 units on a scale Standard Deviation 0.59
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 8	-0.62 units on a scale Standard Deviation 0.74	-0.66 units on a scale Standard Deviation 0.77	-0.44 units on a scale Standard Deviation 0.66
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 16	-0.92 units on a scale Standard Deviation 0.75	-0.82 units on a scale Standard Deviation 0.72	-0.81 units on a scale Standard Deviation 0.74
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 24	-1.10 units on a scale Standard Deviation 0.69	-1.22 units on a scale Standard Deviation 0.62	-0.96 units on a scale Standard Deviation 0.62
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 32	-1.14 units on a scale Standard Deviation 0.69	-1.13 units on a scale Standard Deviation 0.65	-0.91 units on a scale Standard Deviation 0.55
Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Change at Week 40	-1.29 units on a scale Standard Deviation 0.73	-1.09 units on a scale Standard Deviation 0.60	-1.02 units on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24 and 56

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

Average LBPI was assessed on an 11-point numeric rating scale (NRS). Participants described their average LBPI during the past 24 hours (at each specified/scheduled time point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. Percentage of participants with cumulative reduction (as percent change) (greater than [>] 0%; >= 10, 20, 30, 40, 50, 60, 70, 80, 90 and equals to [=] 100%) in average LBPI from baseline to weeks 16, 24 and 56 were reported. Participants (%) might have been counted more than once under various rows.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >=20%	76.1 percentage of participants	67.7 percentage of participants	66.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >=60%	33.7 percentage of participants	25.8 percentage of participants	16.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >=20%	69.6 percentage of participants	55.9 percentage of participants	55.4 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >=30%	65.2 percentage of participants	51.6 percentage of participants	53.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >=70%	25.0 percentage of participants	21.5 percentage of participants	10.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >0%	89.1 percentage of participants	81.7 percentage of participants	81.5 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >=10%	85.9 percentage of participants	77.4 percentage of participants	78.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >=30%	71.7 percentage of participants	57.0 percentage of participants	58.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >=40%	59.8 percentage of participants	46.2 percentage of participants	45.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >=50%	51.1 percentage of participants	35.5 percentage of participants	32.6 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >=70%	19.6 percentage of participants	17.2 percentage of participants	8.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >=80%	13.0 percentage of participants	14.0 percentage of participants	6.5 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: >=90%	3.3 percentage of participants	4.3 percentage of participants	2.2 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 16: =100%	3.3 percentage of participants	4.3 percentage of participants	2.2 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >0%	72.8 percentage of participants	60.2 percentage of participants	59.8 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >=10%	70.7 percentage of participants	57.0 percentage of participants	57.6 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >=40%	57.6 percentage of participants	48.4 percentage of participants	46.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >=50%	50.0 percentage of participants	43.0 percentage of participants	38.0 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >=60%	38.0 percentage of participants	35.5 percentage of participants	20.7 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >=80%	17.4 percentage of participants	16.1 percentage of participants	4.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: >=90%	6.5 percentage of participants	4.3 percentage of participants	1.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 24: =100%	2.2 percentage of participants	3.2 percentage of participants	0 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=0%	68.5 percentage of participants	51.6 percentage of participants	52.2 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=10%	68.5 percentage of participants	50.5 percentage of participants	51.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=20%	64.1 percentage of participants	50.5 percentage of participants	51.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=30%	63.0 percentage of participants	47.3 percentage of participants	51.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=40%	59.8 percentage of participants	43.0 percentage of participants	44.6 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=50%	53.3 percentage of participants	38.7 percentage of participants	41.3 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=60%	41.3 percentage of participants	33.3 percentage of participants	32.6 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=70%	35.9 percentage of participants	25.8 percentage of participants	17.4 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=80%	23.9 percentage of participants	14.0 percentage of participants	10.9 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: >=90%	9.8 percentage of participants	4.3 percentage of participants	1.1 percentage of participants
Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 Week 56: =100%	4.3 percentage of participants	2.2 percentage of participants	1.1 percentage of participants

SECONDARY outcome

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

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

Average LBPI was assessed on an 11-point numeric rating scale (NRS). Participants described their average LBPI during the past 24 hours (at each specified/scheduled time point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. Percentage of participants with reduction in average LBPI of at least (>=) 30%, 50%, 70% and 90% at Weeks 16, 24, 40, and 56 compared to baseline are reported here. Participants (%) might have been counted more than once under various rows.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 16: At least 30% reduction	71.7 percentage of participants Interval 61.8 to 80.0	57.0 percentage of participants Interval 46.8 to 66.6	58.7 percentage of participants Interval 48.5 to 68.2
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 16: At least 50% reduction	51.1 percentage of participants Interval 41.0 to 61.1	35.5 percentage of participants Interval 26.5 to 45.6	32.6 percentage of participants Interval 23.9 to 42.7
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 16: At least 70% reduction	19.6 percentage of participants Interval 12.7 to 28.9	17.2 percentage of participants Interval 10.8 to 26.2	8.7 percentage of participants Interval 4.3 to 16.4
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 16: At least 90% reduction	3.3 percentage of participants Interval 0.7 to 9.6	4.3 percentage of participants Interval 1.3 to 10.9	2.2 percentage of participants Interval 0.1 to 8.1
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 24: At least 30% reduction	65.2 percentage of participants Interval 55.0 to 74.2	51.6 percentage of participants Interval 41.6 to 61.5	53.3 percentage of participants Interval 43.1 to 63.1
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 24: At least 50% reduction	50.0 percentage of participants Interval 40.0 to 60.0	43.0 percentage of participants Interval 33.4 to 53.2	38.0 percentage of participants Interval 28.8 to 48.3
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 24: At least 70% reduction	25.0 percentage of participants Interval 17.2 to 34.8	21.5 percentage of participants Interval 14.3 to 31.0	10.9 percentage of participants Interval 5.8 to 19.0
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 24: At least 90% reduction	6.5 percentage of participants Interval 2.8 to 13.8	4.3 percentage of participants Interval 1.3 to 10.9	1.1 percentage of participants Interval 0.0 to 6.5
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 40: At least 30% reduction	66.3 percentage of participants Interval 56.1 to 75.2	48.4 percentage of participants Interval 38.5 to 58.4	48.9 percentage of participants Interval 38.9 to 59.0
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 40: At least 50% reduction	53.3 percentage of participants Interval 43.1 to 63.1	40.9 percentage of participants Interval 31.4 to 51.0	35.9 percentage of participants Interval 26.8 to 46.1
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 40: At least 70% reduction	34.8 percentage of participants Interval 25.8 to 45.0	24.7 percentage of participants Interval 17.0 to 34.4	17.4 percentage of participants Interval 10.9 to 26.5
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 40: At least 90% reduction	7.6 percentage of participants Interval 3.5 to 15.1	5.4 percentage of participants Interval 2.0 to 12.3	0 percentage of participants Interval 0.0 to 4.8
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 56: At least 30% reduction	63.0 percentage of participants Interval 52.8 to 72.2	47.3 percentage of participants Interval 37.5 to 57.4	51.1 percentage of participants Interval 41.0 to 61.1
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 56: At least 50% reduction	53.3 percentage of participants Interval 43.1 to 63.1	38.7 percentage of participants Interval 29.4 to 48.9	41.3 percentage of participants Interval 31.8 to 51.5
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 56: At least 70% reduction	35.9 percentage of participants Interval 26.8 to 46.1	25.8 percentage of participants Interval 17.9 to 35.6	17.4 percentage of participants Interval 10.9 to 26.5
Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 Week 56: At least 90% reduction	9.8 percentage of participants Interval 5.0 to 17.8	4.3 percentage of participants Interval 1.3 to 10.9	1.1 percentage of participants Interval 0.0 to 6.5

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified time points. BPI-sf scores for worst pain: participants were asked to rate their pain by circling any 1 number from 0 (no pain) to 10 (pain as bad as you can imagine) that best describes their pain at its worst in the last 24 hours; higher scores indicated worse pain.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 2	-0.82 units on a scale Standard Deviation 1.26	-0.81 units on a scale Standard Deviation 1.67	-0.61 units on a scale Standard Deviation 1.48
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 4	-1.25 units on a scale Standard Deviation 1.82	-1.22 units on a scale Standard Deviation 1.89	-0.95 units on a scale Standard Deviation 1.68
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 8	-1.65 units on a scale Standard Deviation 1.97	-1.89 units on a scale Standard Deviation 2.18	-1.28 units on a scale Standard Deviation 1.69
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 16	-3.26 units on a scale Standard Deviation 2.03	-2.92 units on a scale Standard Deviation 2.32	-2.67 units on a scale Standard Deviation 2.13
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 24	-4.27 units on a scale Standard Deviation 1.99	-4.78 units on a scale Standard Deviation 1.81	-4.13 units on a scale Standard Deviation 1.79
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 40	-4.70 units on a scale Standard Deviation 1.85	-4.64 units on a scale Standard Deviation 1.59	-4.39 units on a scale Standard Deviation 1.85
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 56	-4.76 units on a scale Standard Deviation 1.96	-4.70 units on a scale Standard Deviation 2.03	-4.47 units on a scale Standard Deviation 1.91
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 64	-3.71 units on a scale Standard Deviation 2.25	-3.51 units on a scale Standard Deviation 1.99	-3.91 units on a scale Standard Deviation 2.28

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for average pain: participants were asked to rate their pain by circling any 1 number from 0 (no pain) to 10 (pain as bad as you can imagine) that best describes their pain on average in the last 24 hours; higher scores indicated worse pain.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 2	-0.68 units on a scale Standard Deviation 1.35	-0.78 units on a scale Standard Deviation 1.44	-0.50 units on a scale Standard Deviation 1.36
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 4	-1.12 units on a scale Standard Deviation 1.75	-1.28 units on a scale Standard Deviation 1.72	-1.01 units on a scale Standard Deviation 1.43
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 8	-1.49 units on a scale Standard Deviation 1.84	-1.87 units on a scale Standard Deviation 1.99	-1.16 units on a scale Standard Deviation 1.73
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 16	-3.07 units on a scale Standard Deviation 2.03	-3.07 units on a scale Standard Deviation 2.03	-2.57 units on a scale Standard Deviation 1.89
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 24	-4.10 units on a scale Standard Deviation 1.73	-4.66 units on a scale Standard Deviation 1.52	-3.92 units on a scale Standard Deviation 1.66
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 40	-4.38 units on a scale Standard Deviation 1.46	-4.50 units on a scale Standard Deviation 1.39	-4.16 units on a scale Standard Deviation 1.61
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 56	-4.43 units on a scale Standard Deviation 1.70	-4.42 units on a scale Standard Deviation 1.59	-4.30 units on a scale Standard Deviation 1.63
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 64	-3.53 units on a scale Standard Deviation 1.93	-3.72 units on a scale Standard Deviation 1.62	-3.70 units on a scale Standard Deviation 1.91

SECONDARY outcome

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

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

BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. Pain interference index was calculated as the mean of the 7 BPI-sf pain interference items: pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Each of the 7 items had score range from 0 (does not interfere) to 10 (completely interferes), higher scores indicated more interference in daily activities due to pain. Overall score range for pain interference index was 0 (no interference) to 10 (complete interference), higher score = higher interference.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 2	-0.98 units on a scale Standard Deviation 1.76	-0.87 units on a scale Standard Deviation 1.51	-0.78 units on a scale Standard Deviation 1.94
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 4	-1.43 units on a scale Standard Deviation 1.94	-1.32 units on a scale Standard Deviation 1.74	-1.16 units on a scale Standard Deviation 1.92
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 8	-1.75 units on a scale Standard Deviation 1.99	-1.84 units on a scale Standard Deviation 1.93	-1.51 units on a scale Standard Deviation 2.14
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 16	-2.98 units on a scale Standard Deviation 2.10	-2.70 units on a scale Standard Deviation 2.13	-2.62 units on a scale Standard Deviation 2.39
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 24	-3.76 units on a scale Standard Deviation 2.07	-3.74 units on a scale Standard Deviation 2.02	-3.52 units on a scale Standard Deviation 1.97
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 40	-3.88 units on a scale Standard Deviation 1.92	-3.48 units on a scale Standard Deviation 2.02	-3.69 units on a scale Standard Deviation 2.03
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 56	-3.86 units on a scale Standard Deviation 2.09	-3.79 units on a scale Standard Deviation 1.95	-3.54 units on a scale Standard Deviation 2.25
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 64	-3.31 units on a scale Standard Deviation 2.26	-3.29 units on a scale Standard Deviation 2.07	-3.17 units on a scale Standard Deviation 2.42

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with general activity: participants were asked to circle from any 1 number from 0 (no interference) to 10 (complete interference) that described how, during the past 24 hours, pain has interfered with their general activity; higher scores indicated higher interference.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 2	-1.10 units on a scale Standard Deviation 1.95	-1.05 units on a scale Standard Deviation 1.95	-0.67 units on a scale Standard Deviation 2.20
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 4	-1.68 units on a scale Standard Deviation 2.52	-1.54 units on a scale Standard Deviation 2.26	-1.26 units on a scale Standard Deviation 2.20
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 8	-2.04 units on a scale Standard Deviation 2.44	-2.04 units on a scale Standard Deviation 2.61	-1.77 units on a scale Standard Deviation 2.40
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 16	-3.29 units on a scale Standard Deviation 2.49	-3.04 units on a scale Standard Deviation 2.56	-2.92 units on a scale Standard Deviation 2.45
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 24	-4.30 units on a scale Standard Deviation 2.26	-4.62 units on a scale Standard Deviation 2.00	-4.06 units on a scale Standard Deviation 2.04
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 40	-4.59 units on a scale Standard Deviation 2.07	-4.36 units on a scale Standard Deviation 2.11	-4.23 units on a scale Standard Deviation 1.99
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 56	-4.49 units on a scale Standard Deviation 2.21	-4.65 units on a scale Standard Deviation 1.97	-4.19 units on a scale Standard Deviation 2.21
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 64	-3.89 units on a scale Standard Deviation 2.46	-3.88 units on a scale Standard Deviation 2.33	-3.63 units on a scale Standard Deviation 2.23

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with walking ability: participants were asked to circle from any 1 number from 0 (does not interfere) to 10 (completely interferes) that described how, during the past 24 hours, pain has interfered with their walking ability; higher scores indicated higher interference.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 2	-0.89 units on a scale Standard Deviation 2.33	-1.06 units on a scale Standard Deviation 2.13	-0.73 units on a scale Standard Deviation 2.26
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 4	-1.37 units on a scale Standard Deviation 2.49	-1.23 units on a scale Standard Deviation 2.35	-1.12 units on a scale Standard Deviation 2.40
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 8	-1.59 units on a scale Standard Deviation 2.41	-1.91 units on a scale Standard Deviation 2.41	-1.37 units on a scale Standard Deviation 2.54
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 16	-2.89 units on a scale Standard Deviation 2.53	-2.60 units on a scale Standard Deviation 2.63	-2.52 units on a scale Standard Deviation 2.86
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 24	-3.81 units on a scale Standard Deviation 2.51	-3.76 units on a scale Standard Deviation 2.40	-3.44 units on a scale Standard Deviation 2.01
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 40	-3.78 units on a scale Standard Deviation 2.30	-3.36 units on a scale Standard Deviation 2.26	-3.64 units on a scale Standard Deviation 2.04
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 56	-3.76 units on a scale Standard Deviation 2.39	-3.58 units on a scale Standard Deviation 2.37	-3.56 units on a scale Standard Deviation 2.28
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 64	-3.18 units on a scale Standard Deviation 2.53	-3.09 units on a scale Standard Deviation 2.45	-3.16 units on a scale Standard Deviation 2.53

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with sleep: participants were asked to circle from any 1 number from 0 (does not interfere) to 10 (completely interferes) that described how, during the past 24 hours, pain has interfered with their sleep; higher scores indicated higher interference.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 2	-1.02 units on a scale Standard Deviation 2.57	-0.77 units on a scale Standard Deviation 2.34	-0.59 units on a scale Standard Deviation 2.37
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 4	-1.28 units on a scale Standard Deviation 2.54	-1.37 units on a scale Standard Deviation 2.32	-0.85 units on a scale Standard Deviation 2.57
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 8	-1.80 units on a scale Standard Deviation 2.64	-1.96 units on a scale Standard Deviation 2.45	-1.29 units on a scale Standard Deviation 2.44
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 16	-2.97 units on a scale Standard Deviation 2.58	-2.75 units on a scale Standard Deviation 2.69	-2.30 units on a scale Standard Deviation 2.89
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 24	-3.62 units on a scale Standard Deviation 2.55	-3.46 units on a scale Standard Deviation 2.73	-3.19 units on a scale Standard Deviation 2.74
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 40	-3.73 units on a scale Standard Deviation 2.48	-3.25 units on a scale Standard Deviation 2.82	-3.41 units on a scale Standard Deviation 2.71
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 56	-3.78 units on a scale Standard Deviation 2.60	-3.65 units on a scale Standard Deviation 2.92	-3.19 units on a scale Standard Deviation 2.91
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 Change at Week 64	-3.26 units on a scale Standard Deviation 2.73	-3.35 units on a scale Standard Deviation 2.80	-2.79 units on a scale Standard Deviation 3.09

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with normal work: participants were asked to circle from any 1 number from 0 (does not interfere) to 10 (completely interferes) that described how, during the past 24 hours, pain has interfered with their normal work; higher scores indicated higher interference.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64 Change at Week 2	-1.04 units on a scale Standard Deviation 2.44	-1.17 units on a scale Standard Deviation 2.28	-0.96 units on a scale Standard Deviation 2.33
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64 Change at Week 4	-1.49 units on a scale Standard Deviation 2.39	-1.39 units on a scale Standard Deviation 2.29	-1.30 units on a scale Standard Deviation 2.27
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64 Change at Week 8	-1.93 units on a scale Standard Deviation 2.55	-2.11 units on a scale Standard Deviation 2.49	-1.69 units on a scale Standard Deviation 2.43
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64 Change at Week 16	-3.35 units on a scale Standard Deviation 2.71	-3.04 units on a scale Standard Deviation 2.68	-2.93 units on a scale Standard Deviation 2.74
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64 Change at Week 24	-4.44 units on a scale Standard Deviation 2.58	-4.26 units on a scale Standard Deviation 2.51	-4.02 units on a scale Standard Deviation 2.15
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64 Change at Week 40	-4.52 units on a scale Standard Deviation 2.33	-3.86 units on a scale Standard Deviation 2.29	-4.16 units on a scale Standard Deviation 2.52
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64 Change at Week 56	-4.49 units on a scale Standard Deviation 2.78	-4.16 units on a scale Standard Deviation 2.35	-4.14 units on a scale Standard Deviation 2.36
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64 Change at Week 64	-3.84 units on a scale Standard Deviation 2.81	-3.53 units on a scale Standard Deviation 2.59	-3.77 units on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: Weeks 16, 24, 40 and 56

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

Chronic low back pain responder index analysis is a composite endpoint of average low back pain intensity (aLBPI) score, PGA of low back pain, and RMDQ total score. aLBPI: evaluate average pain during the past 24 hours, range 0 (no pain) to 10 (worst possible pain), higher scores = higher worse pain. PGA of low back pain: evaluated participants' well-being due to low back pain on day of assessment, range 1 (very good) to 5 (very poor), higher scores = worse condition. RMDQ total score: assessed ability to perform daily activities, range 0 (no disability) to 24 (maximum disability), higher scores = more disability. Participants were successful responders if they had: >=30 percent reduction in aLBPI from baseline to particular week; decrease of >=30 percent in PGA of low back pain from baseline to particular week and no worsening (increase) in RMDQ total score from baseline to particular week.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Percentage of Participants With Chronic Low Back Pain Responders Index at Weeks 16, 24, 40 and 56 Week 16	54.3 percentage of participants Interval 44.2 to 64.1	48.4 percentage of participants Interval 38.5 to 58.4	50.0 percentage of participants Interval 40.0 to 60.0
Percentage of Participants With Chronic Low Back Pain Responders Index at Weeks 16, 24, 40 and 56 Week 24	53.3 percentage of participants Interval 43.1 to 63.1	45.2 percentage of participants Interval 35.4 to 55.3	42.4 percentage of participants Interval 32.8 to 52.6
Percentage of Participants With Chronic Low Back Pain Responders Index at Weeks 16, 24, 40 and 56 Week 40	56.5 percentage of participants Interval 46.3 to 66.2	43.0 percentage of participants Interval 33.4 to 53.2	41.3 percentage of participants Interval 31.8 to 51.5
Percentage of Participants With Chronic Low Back Pain Responders Index at Weeks 16, 24, 40 and 56 Week 56	51.1 percentage of participants Interval 41.0 to 61.1	39.8 percentage of participants Interval 30.4 to 50.0	42.4 percentage of participants Interval 32.8 to 52.6

SECONDARY outcome

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

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

PGA of low back pain assessed by asking question to participants: "Considering all ways your low back pain affects you, how are you doing today?" They responded on 5 point Likert scale ranging from 1 to 5, using IRT, where 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. Percentage of participants with positive change of at least 2 points from baseline in PGA of low back pain were reported.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Percentage of Participants Achieving Change of >=2 Points From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 16, 24, 40 and 56 Week 16	17.4 percentage of participants Interval 10.9 to 26.5	12.9 percentage of participants Interval 7.4 to 21.4	16.3 percentage of participants Interval 10.0 to 25.3
Percentage of Participants Achieving Change of >=2 Points From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 16, 24, 40 and 56 Week 24	18.5 percentage of participants Interval 11.8 to 27.7	15.1 percentage of participants Interval 9.1 to 23.8	9.8 percentage of participants Interval 5.0 to 17.8
Percentage of Participants Achieving Change of >=2 Points From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 16, 24, 40 and 56 Week 40	23.9 percentage of participants Interval 16.3 to 33.6	11.8 percentage of participants Interval 6.6 to 20.1	9.8 percentage of participants Interval 5.0 to 17.8
Percentage of Participants Achieving Change of >=2 Points From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 16, 24, 40 and 56 Week 56	18.5 percentage of participants Interval 11.8 to 27.7	11.8 percentage of participants Interval 6.6 to 20.1	10.9 percentage of participants Interval 5.8 to 19.0

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = Participants evaluable for this outcome measure for specified rows.

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

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Baseline: Usual activities	2.4 units on a scale Standard Deviation 0.83	2.4 units on a scale Standard Deviation 0.83	2.3 units on a scale Standard Deviation 0.79
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Baseline: Pain/Discomfort	2.9 units on a scale Standard Deviation 0.69	2.9 units on a scale Standard Deviation 0.71	2.9 units on a scale Standard Deviation 0.64
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Baseline: Anxiety/Depression	1.8 units on a scale Standard Deviation 0.83	1.8 units on a scale Standard Deviation 0.97	1.6 units on a scale Standard Deviation 0.81
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 16: Mobility	1.6 units on a scale Standard Deviation 0.77	1.5 units on a scale Standard Deviation 0.80	1.5 units on a scale Standard Deviation 0.77
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 16: Self-care	1.2 units on a scale Standard Deviation 0.48	1.1 units on a scale Standard Deviation 0.35	1.2 units on a scale Standard Deviation 0.48
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 16: Usual activities	1.6 units on a scale Standard Deviation 0.71	1.5 units on a scale Standard Deviation 0.66	1.6 units on a scale Standard Deviation 0.69
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 16: Pain/Discomfort	2.0 units on a scale Standard Deviation 0.74	2.0 units on a scale Standard Deviation 0.75	2.1 units on a scale Standard Deviation 0.67
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 16: Anxiety/Depression	1.2 units on a scale Standard Deviation 0.59	1.2 units on a scale Standard Deviation 0.52	1.2 units on a scale Standard Deviation 0.47
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 56: Mobility	1.3 units on a scale Standard Deviation 0.55	1.3 units on a scale Standard Deviation 0.54	1.4 units on a scale Standard Deviation 0.73
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 56: Self-care	1.0 units on a scale Standard Deviation 0.21	1.1 units on a scale Standard Deviation 0.26	1.0 units on a scale Standard Deviation 0.15
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 56: Usual activities	1.3 units on a scale Standard Deviation 0.46	1.3 units on a scale Standard Deviation 0.50	1.3 units on a scale Standard Deviation 0.51
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 56: Pain/Discomfort	1.7 units on a scale Standard Deviation 0.63	1.7 units on a scale Standard Deviation 0.59	1.8 units on a scale Standard Deviation 0.55
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Week 56: Anxiety/Depression	1.1 units on a scale Standard Deviation 0.56	1.1 units on a scale Standard Deviation 0.29	1.1 units on a scale Standard Deviation 0.26
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Baseline: Mobility	2.3 units on a scale Standard Deviation 0.78	2.2 units on a scale Standard Deviation 0.95	2.3 units on a scale Standard Deviation 0.97
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 Baseline: Self-care	1.8 units on a scale Standard Deviation 0.81	1.6 units on a scale Standard Deviation 0.82	1.6 units on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = Participants evaluable for this outcome measure at specified time points.

EQ-5D health state profile has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses from each of the 5 domains were used to calculate overall health state/a single utility index value. Example: if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined single index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. Japan value sets (with all possible health states) was used in the study, overall health utility score ranged from -0.111 (minimum score) to 1 (maximum score). Higher (positive) scores = better health state.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Overall Health Utility Score/ Index Value Baseline	0.61 units on a scale Standard Deviation 0.09	0.62 units on a scale Standard Deviation 0.11	0.63 units on a scale Standard Deviation 0.09
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Overall Health Utility Score/ Index Value Week 16	0.76 units on a scale Standard Deviation 0.14	0.77 units on a scale Standard Deviation 0.13	0.76 units on a scale Standard Deviation 0.13
European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Overall Health Utility Score/ Index Value Week 56	0.83 units on a scale Standard Deviation 0.13	0.83 units on a scale Standard Deviation 0.13	0.82 units on a scale Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = Participants evaluable for this outcome measure at specified time points.

WPAI:LBP is a participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. Percentage of work time missed by participants due to CLBP was recorded on a score range of 0 (no impact on work time) to 100 (extreme impact on work time), higher scores indicated greater work time missed and lesser productivity.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Work Time Missed Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Baseline	5.0 percentage of work time missed Standard Deviation 17.40	5.7 percentage of work time missed Standard Deviation 16.91	5.8 percentage of work time missed Standard Deviation 18.74
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Work Time Missed Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 16	-0.8 percentage of work time missed Standard Deviation 12.53	-4.8 percentage of work time missed Standard Deviation 15.11	-1.9 percentage of work time missed Standard Deviation 14.04
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Work Time Missed Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 56	-2.4 percentage of work time missed Standard Deviation 7.15	-2.3 percentage of work time missed Standard Deviation 10.47	-1.3 percentage of work time missed Standard Deviation 4.13
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Work Time Missed Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 64	-1.6 percentage of work time missed Standard Deviation 6.67	-0.6 percentage of work time missed Standard Deviation 6.37	3.1 percentage of work time missed Standard Deviation 16.20

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = Participants evaluable for this outcome measure at specified time points.

WPAI: LBP is a participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. Percentage of impairment while working due to CLBP was recorded on a score range of 0 (no impairment) to 100 (extreme impairment), higher scores indicated greater impairment while working and lesser productivity.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Impairment While Working Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Baseline	55.4 percentage of impairment Standard Deviation 24.29	53.7 percentage of impairment Standard Deviation 24.97	56.4 percentage of impairment Standard Deviation 22.03
Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Impairment While Working Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 16	-31.6 percentage of impairment Standard Deviation 26.68	-24.7 percentage of impairment Standard Deviation 30.29	-28.3 percentage of impairment Standard Deviation 25.57
Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Impairment While Working Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 56	-38.7 percentage of impairment Standard Deviation 24.99	-36.6 percentage of impairment Standard Deviation 28.69	-27.1 percentage of impairment Standard Deviation 26.23
Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Impairment While Working Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 64	-31.9 percentage of impairment Standard Deviation 23.19	-33.9 percentage of impairment Standard Deviation 28.01	-30.8 percentage of impairment Standard Deviation 25.91

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

WPAI: LBP is a participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. Percentage of overall work impairment due to CLBP was recorded on a score range of 0 (no impairment) to 100 (extreme impairment), higher scores indicated greater overall work impairment and lesser productivity.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Overall Work Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Baseline	56.0 percentage of impairment Standard Deviation 24.65	56.0 percentage of impairment Standard Deviation 24.38	57.2 percentage of impairment Standard Deviation 22.26
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Overall Work Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 16	-31.8 percentage of impairment Standard Deviation 27.33	-26.8 percentage of impairment Standard Deviation 29.90	-27.8 percentage of impairment Standard Deviation 27.29
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Overall Work Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 56	-39.2 percentage of impairment Standard Deviation 25.51	-38.3 percentage of impairment Standard Deviation 28.98	-27.7 percentage of impairment Standard Deviation 25.76
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Overall Work Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 64	-32.1 percentage of impairment Standard Deviation 23.44	-33.7 percentage of impairment Standard Deviation 29.52	-27.9 percentage of impairment Standard Deviation 26.67

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 56 and 64

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

WPAI: LBP is a participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. Percentage of daily activity impairment due to CLBP was recorded on a score range of 0 (no impairment) to 100 (extreme impairment), higher scores indicated greater daily activity impairment and lesser productivity.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Activity Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Baseline	57.8 percentage of impairment Standard Deviation 20.10	53.7 percentage of impairment Standard Deviation 22.69	54.7 percentage of impairment Standard Deviation 21.35
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Activity Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 16	-30.1 percentage of impairment Standard Deviation 24.87	-25.0 percentage of impairment Standard Deviation 26.04	-25.4 percentage of impairment Standard Deviation 26.13
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Activity Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 56	-42.1 percentage of impairment Standard Deviation 24.11	-35.1 percentage of impairment Standard Deviation 25.19	-32.6 percentage of impairment Standard Deviation 23.63
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Activity Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 Change at Week 64	-37.3 percentage of impairment Standard Deviation 23.27	-34.4 percentage of impairment Standard Deviation 23.13	-33.0 percentage of impairment Standard Deviation 27.21

SECONDARY outcome

Timeframe: Baseline up to Week 56

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

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

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants Who Discontinued Due to Lack of Efficacy	1 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Participants who discontinued due to lack of efficacy analyzed.

Time to discontinuation (in days) due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy. Results reported below are contributed only by participants who discontinued due to lack of efficacy.

Outcome measures

Measure	Tanezumab 5 mg n=1 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=4 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=1 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Time to Discontinuation Due to Lack of Efficacy Minimum	111 days	15 days	141 days
Time to Discontinuation Due to Lack of Efficacy 1st Percentile	111 days	15 days	141 days
Time to Discontinuation Due to Lack of Efficacy 2nd Percentile	NA days Cannot be estimated using Kaplan-Meier method due to an insufficient number of participants with events.	29 days	141 days
Time to Discontinuation Due to Lack of Efficacy 5th Percentile	NA days Cannot be estimated using Kaplan-Meier method due to an insufficient number of participants with events.	NA days Cannot be estimated using Kaplan-Meier method due to an insufficient number of participants with events.	NA days Cannot be estimated using Kaplan-Meier method due to an insufficient number of participants with events.
Time to Discontinuation Due to Lack of Efficacy Maximum	111 days	113 days	141 days

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64

Population: ITT population was analyzed. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. Observed data: analysis was performed using all available data at specified weeks and no imputation technique was used for missing data.

In case of inadequate pain relief, acetaminophen/paracetamol tablets up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Number of participants with any use of rescue medication during each specified/scheduled study week were summarized.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 2	36 Participants	24 Participants	33 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 4	30 Participants	23 Participants	27 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 8	28 Participants	19 Participants	25 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 12	17 Participants	14 Participants	27 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 16	14 Participants	18 Participants	21 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 24	21 Participants	10 Participants	14 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 32	14 Participants	9 Participants	12 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 40	11 Participants	10 Participants	5 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 48	15 Participants	9 Participants	8 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 56	16 Participants	9 Participants	9 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 64	23 Participants	13 Participants	14 Participants

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Last observation was carried forward for missing data.

In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Number of participants with any use of rescue medication during each specified/scheduled study week were summarized.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 2	37 Participants	24 Participants	33 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 4	30 Participants	24 Participants	28 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 8	28 Participants	19 Participants	27 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 12	17 Participants	16 Participants	29 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 16	15 Participants	21 Participants	26 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 24	32 Participants	26 Participants	32 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 32	27 Participants	27 Participants	34 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 40	24 Participants	30 Participants	27 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 48	28 Participants	28 Participants	30 Participants
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) Week 56	29 Participants	28 Participants	32 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64

Population: ITT population was analyzed. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. Observed data: analysis was performed using all available data at specified weeks and no imputation technique was used for missing data.

In case of inadequate pain relief, acetaminophen/paracetamol tablets up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Number of days the participants used the rescue medication during each specified/scheduled study week were summarized.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 4	0.8 days Standard Deviation 1.29	0.6 days Standard Deviation 1.27	0.7 days Standard Deviation 1.37
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 2	0.9 days Standard Deviation 1.37	0.8 days Standard Deviation 1.57	0.8 days Standard Deviation 1.35
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 8	0.6 days Standard Deviation 1.08	0.4 days Standard Deviation 0.92	0.7 days Standard Deviation 1.22
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 12	0.4 days Standard Deviation 0.98	0.4 days Standard Deviation 1.14	0.7 days Standard Deviation 1.34
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 16	0.5 days Standard Deviation 1.15	0.4 days Standard Deviation 0.95	0.5 days Standard Deviation 1.10
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 24	1.1 days Standard Deviation 2.14	0.4 days Standard Deviation 1.41	1.0 days Standard Deviation 2.10
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 32	0.7 days Standard Deviation 1.75	0.3 days Standard Deviation 1.14	0.7 days Standard Deviation 1.79
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 40	0.5 days Standard Deviation 1.46	0.5 days Standard Deviation 1.27	0.5 days Standard Deviation 1.63
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 48	0.8 days Standard Deviation 1.84	0.4 days Standard Deviation 1.17	0.6 days Standard Deviation 1.72
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 56	0.7 days Standard Deviation 1.69	0.4 days Standard Deviation 1.26	0.4 days Standard Deviation 1.50
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data Week 64	1.1 days Standard Deviation 1.89	0.6 days Standard Deviation 1.54	1.0 days Standard Deviation 2.08

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Last observation was carried forward for missing data.

In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Number of days the participants used the rescue medication during each specified/scheduled study week were summarized.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 2	1.0 days Standard Deviation 1.37	0.8 days Standard Deviation 1.57	0.8 days Standard Deviation 1.35
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 4	0.8 days Standard Deviation 1.29	0.6 days Standard Deviation 1.27	0.8 days Standard Deviation 1.40
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 8	0.6 days Standard Deviation 1.08	0.4 days Standard Deviation 0.95	0.8 days Standard Deviation 1.43
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 12	0.4 days Standard Deviation 0.98	0.5 days Standard Deviation 1.18	0.8 days Standard Deviation 1.56
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 16	0.5 days Standard Deviation 1.24	0.6 days Standard Deviation 1.47	0.7 days Standard Deviation 1.46
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 24	1.5 days Standard Deviation 2.49	1.2 days Standard Deviation 2.36	1.6 days Standard Deviation 2.66
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 32	1.3 days Standard Deviation 2.43	1.2 days Standard Deviation 2.36	1.5 days Standard Deviation 2.58
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 40	1.2 days Standard Deviation 2.34	1.3 days Standard Deviation 2.35	1.4 days Standard Deviation 2.56
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 48	1.3 days Standard Deviation 2.46	1.2 days Standard Deviation 2.35	1.5 days Standard Deviation 2.56
Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF Week 56	1.3 days Standard Deviation 2.41	1.3 days Standard Deviation 2.36	1.4 days Standard Deviation 2.52

SECONDARY outcome

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

Population: ITT population was analyzed. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. Observed data: analysis was performed using all available data at specified weeks and no imputation technique was used for missing data.

In case of inadequate pain relief, acetaminophen/paracetamol tablets up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Amount of rescue medication used during each specified/scheduled study week were summarized.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: Observed Data Week 2	1029 milligrams Standard Deviation 2118	701 milligrams Standard Deviation 1710	809 milligrams Standard Deviation 1789
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: Observed Data Week 4	885 milligrams Standard Deviation 1913	440 milligrams Standard Deviation 1125	812 milligrams Standard Deviation 1744
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: Observed Data Week 8	813 milligrams Standard Deviation 1792	559 milligrams Standard Deviation 1577	776 milligrams Standard Deviation 1805
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: Observed Data Week 12	655 milligrams Standard Deviation 1845	477 milligrams Standard Deviation 1674	657 milligrams Standard Deviation 1585
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: Observed Data Week 16	680 milligrams Standard Deviation 1850	292 milligrams Standard Deviation 1135	642 milligrams Standard Deviation 1810

SECONDARY outcome

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

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Last observation was carried forward for missing data.

In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Amount of rescue medication used during each specified/scheduled study week were summarized.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: LOCF Week 2	1042 milligrams Standard Deviation 2115	701 milligrams Standard Deviation 1710	809 milligrams Standard Deviation 1789
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: LOCF Week 4	885 milligrams Standard Deviation 1913	543 milligrams Standard Deviation 1428	821 milligrams Standard Deviation 1737
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: LOCF Week 8	813 milligrams Standard Deviation 1792	661 milligrams Standard Deviation 1806	855 milligrams Standard Deviation 1900
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: LOCF Week 12	648 milligrams Standard Deviation 1837	631 milligrams Standard Deviation 1956	742 milligrams Standard Deviation 1710
Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: LOCF Week 16	693 milligrams Standard Deviation 1847	584 milligrams Standard Deviation 1919	652 milligrams Standard Deviation 1800

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' signifies the number of participants evaluable for specified rows.

Low back pain HCRU assessed utilization of healthcare resources usage during last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Visits of services directly related to low back pain evaluated were: visits to primary care physician, neurologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, nutritionist/dietician, radiologist and other practitioner. Participants might have been counted more than once under various rows. Only those rows have been reported which had at least 1 participant evaluable for any reporting arm.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Primary Care Physician	4.9 visits Standard Deviation 11.79	3.1 visits Standard Deviation 1.18	4.1 visits Standard Deviation 4.77
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Neurologist	2.0 visits	—	—
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline:Physician Assistant or Nurse Practitioner	3.0 visits	—	—
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Pain Specialist	4.5 visits Standard Deviation 1.00	2.8 visits Standard Deviation 0.50	5.5 visits Standard Deviation 3.70
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Orthopedist	3.9 visits Standard Deviation 4.83	3.3 visits Standard Deviation 1.25	3.9 visits Standard Deviation 3.81
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Physical Therapist	17.5 visits Standard Deviation 22.94	3.5 visits Standard Deviation 0.71	11.8 visits Standard Deviation 1.26
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Chiropractor	2.0 visits	2.0 visits	4.0 visits Standard Deviation 4.24
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Alternative Medicine Or Therapy	—	13.5 visits Standard Deviation 14.85	4.0 visits Standard Deviation 2.83
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Nutritionist/Dietician	—	—	1.0 visits
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Radiologist	1.0 visits	—	—
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Baseline: Other Practitioner	2.0 visits Standard Deviation 1.00	2.6 visits Standard Deviation 1.52	8.8 visits Standard Deviation 11.78
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Primary Care Physician	4.9 visits Standard Deviation 14.98	1.5 visits Standard Deviation 1.25	1.8 visits Standard Deviation 1.82
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Neurologist	5.0 visits	—	1.0 visits
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Physician Assistant or Nurse Practitioner	2.0 visits	—	—
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Pain Specialist	—	1.7 visits Standard Deviation 0.58	2.3 visits Standard Deviation 1.89
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Orthopedist	4.0 visits Standard Deviation 11.33	1.8 visits Standard Deviation 1.46	4.1 visits Standard Deviation 14.18
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Physical Therapist	6.5 visits Standard Deviation 3.42	—	7.7 visits Standard Deviation 11.31
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Chiropractor	—	6.0 visits	—
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Alternative Medicine Or Therapy	5.0 visits	16.5 visits Standard Deviation 19.09	2.0 visits
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Podiatrist	—	—	1.0 visits
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Radiologist	3.0 visits Standard Deviation 2.83	—	1.0 visits
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 64: Other Practitioner	3.0 visits Standard Deviation 2.92	3.4 visits Standard Deviation 2.51	16.3 visits Standard Deviation 36.56
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 80: Primary Care Physician	1.5 visits Standard Deviation 0.85	1.4 visits Standard Deviation 0.89	2.9 visits Standard Deviation 4.49
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 80: Physician Assistant or Nurse Practitioner	1.0 visits	—	—
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 80: Pain Specialist	1.0 visits	1.0 visits	2.0 visits Standard Deviation 0.00
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 80: Orthopedist	2.8 visits Standard Deviation 6.61	1.7 visits Standard Deviation 1.28	2.6 visits Standard Deviation 3.55
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 80: Physical Therapist	12.0 visits	—	4.0 visits
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 80: Chiropractor	—	—	3.0 visits
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 80: Alternative Medicine Or Therapy	—	—	9.0 visits
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 80: Radiologist	1.0 visits	1.0 visits	—
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain Week 80: Other Practitioner	4.0 visits Standard Deviation 3.61	4.0 visits	2.3 visits Standard Deviation 1.15

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' signifies the number of participants who were evaluable at specified time points.

Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Number of participants who visited the emergency room due to low back pain were evaluated.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Health Care Resource Utilization (HCRU): Number of Participants Visited to the Emergency Room Due to Low Back Pain Baseline	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Visited to the Emergency Room Due to Low Back Pain Week 64	0 Participants	0 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Visited to the Emergency Room Due to Low Back Pain Week 80	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

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

Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who were hospitalized due to low back pain.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=91 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain Baseline	0 Participants	1 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain Week 64	1 Participants	1 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain Week 80	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab).Not all participants of the ITT population had data collected at each of time points. Hence, Overall number of participants analyzed=participants evaluable for this outcome measure.

Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Number of nights stayed in the hospital due to low back pain were evaluated.

Outcome measures

Measure	Tanezumab 5 mg n=1 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=2 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=2 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain Baseline	—	24.0 nights Interval 24.0 to 24.0	2.0 nights Interval 2.0 to 2.0
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain Week 64	1.0 nights Interval 1.0 to 1.0	1.0 nights Interval 1.0 to 1.0	2.0 nights Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = Participants who were evaluable for usage of any aids/devices for doing things at specified time points.

Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Number of participants who used any aids/devices for doing things were evaluated. Aids included walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Other aids or devices · Sometimes	1 Participants	2 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Wheelchair use · Often	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Other aids or devices · Often	2 Participants	0 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Other aids or devices · Never	88 Participants	85 Participants	80 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Other aids or devices · Rarely	0 Participants	1 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Other aids or devices · Always	0 Participants	0 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Walking aid use · Never	91 Participants	91 Participants	90 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Walking aid use · Rarely	1 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Walking aid use · Sometimes	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Walking aid use · Often	0 Participants	1 Participants	2 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Walking aid use · Always	0 Participants	1 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Wheelchair use · Never	92 Participants	93 Participants	92 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Wheelchair use · Rarely	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Wheelchair use · Always	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Wheelchair use · Sometimes	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Device/Utensil to Dress Bathe Eat · Never	92 Participants	93 Participants	91 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Device/Utensil to Dress Bathe Eat · Rarely	0 Participants	0 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Device/Utensil to Dress Bathe Eat · Sometimes	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Device/Utensil to Dress Bathe Eat · Often	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Device/Utensil to Dress Bathe Eat · Always	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Other Aids or Devices · Never	90 Participants	87 Participants	86 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Other Aids or Devices · Rarely	1 Participants	1 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Other Aids or Devices · Sometimes	1 Participants	2 Participants	3 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Other Aids or Devices · Often	0 Participants	2 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Baseline: Other Aids or Devices · Always	0 Participants	1 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Walking aid use · Never	88 Participants	86 Participants	85 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Walking aid use · Rarely	1 Participants	0 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Walking aid use · Sometimes	2 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Walking aid use · Often	0 Participants	1 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Walking aid use · Always	0 Participants	1 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Wheelchair use · Never	91 Participants	88 Participants	86 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Wheelchair use · Rarely	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Wheelchair use · Sometimes	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Wheelchair use · Often	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Wheelchair use · Always	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Device/Utensil to Dress Bathe Eat · Never	91 Participants	87 Participants	86 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Device/Utensil to Dress Bathe Eat · Rarely	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Device/Utensil to Dress Bathe Eat · Sometimes	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Device/Utensil to Dress Bathe Eat · Often	0 Participants	1 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 64: Device/Utensil to Dress Bathe Eat · Always	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Walking aid use · Never	61 Participants	41 Participants	42 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Walking aid use · Rarely	1 Participants	1 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Walking aid use · Sometimes	0 Participants	0 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Walking aid use · Often	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Walking aid use · Always	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Wheelchair use · Never	62 Participants	42 Participants	43 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Wheelchair use · Rarely	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Wheelchair use · Sometimes	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Wheelchair use · Often	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Wheelchair use · Always	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Device/Utensil to Dress Bathe Eat · Never	62 Participants	42 Participants	43 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Device/Utensil to Dress Bathe Eat · Rarely	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Device/Utensil to Dress Bathe Eat · Sometimes	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Device/Utensil to Dress Bathe Eat · Often	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Device/Utensil to Dress Bathe Eat · Always	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Other Aids Or Devices · Never	62 Participants	41 Participants	42 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Other Aids Or Devices · Rarely	0 Participants	1 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Other Aids Or Devices · Sometimes	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Other Aids Or Devices · Often	0 Participants	0 Participants	0 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Week 80: Other Aids Or Devices · Always	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants who were evaluable for at specified time points.

Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Number of participants who answered as "Yes" for quitting job due to low back pain, were evaluated.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain Baseline	3 Participants	2 Participants	5 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain Week 64	1 Participants	2 Participants	1 Participants
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain Week 80	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 64 and 80

Population: ITT population. Not all participants of the ITT population had data collected at each of the time points for this outcome measure. "Overall number of participants analyzed" = participants evaluable for this outcome measure. Additional participants apart from the ones who had responded for quitting job responded to duration since quitting.

Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Domain evaluated was duration (in years) at each specified time point since quitting job due to low back pain.

Outcome measures

Measure	Tanezumab 5 mg n=5 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=6 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=6 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain Week 64	3.3 years Interval 3.3 to 3.3	0.7 years Interval 0.3 to 1.5	0.2 years Interval 0.2 to 0.2
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain Baseline	1.5 years Interval 0.6 to 5.7	1.6 years Interval 0.3 to 3.0	2.5 years Interval 0.3 to 10.6
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain Week 80	0.1 years Interval 0.1 to 0.1	—	—

SECONDARY outcome

Timeframe: Weeks 16 and 56

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

TSQM v.II: participant rated 11 items questionnaire. Items 1, 2, 7 to 11 were scored as: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Items 4 to 6 were scored as: 1= extremely dissatisfied, 2= very dissatisfied, 3= somewhat dissatisfied, 4= slightly dissatisfied, 5= not at all dissatisfied. Item 3 was scored as: 0= No, 1= Yes. Four parameters with respect to study medication were evaluated: Effectiveness = ([Item 1+Item 2] - 2 )/12 *100; Side effects = ([Item 4 + Item 5 + Item 6] - 3)/12 *100, if one item is missing then: ([Sum of two completed items]-2]/8 *100; Convenience = ([Item 7 + Item 8 + Item 9] - 3)/18 *100, if one item is missing then: ([Sum of two completed items]-2)/12 *100; Global satisfaction = ([Item 10+Item 11] - 2 ]/12 *100. Each of the 4 parameters had a scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score = greater satisfaction.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=90 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=88 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56 Week 16: Global Satisfaction	63.41 units on a scale Standard Deviation 20.22	62.31 units on a scale Standard Deviation 17.81	61.93 units on a scale Standard Deviation 18.17
Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56 Week 16: Effectiveness	61.41 units on a scale Standard Deviation 21.95	61.48 units on a scale Standard Deviation 20.70	58.05 units on a scale Standard Deviation 18.97
Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56 Week 16: Side Effects	56.94 units on a scale Standard Deviation 20.01	80.56 units on a scale Standard Deviation 19.25	68.75 units on a scale Standard Deviation 7.98
Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56 Week 16: Convenience	64.79 units on a scale Standard Deviation 17.88	66.85 units on a scale Standard Deviation 15.94	64.39 units on a scale Standard Deviation 14.31
Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56 Week 56: Effectiveness	71.30 units on a scale Standard Deviation 20.35	71.32 units on a scale Standard Deviation 18.57	67.05 units on a scale Standard Deviation 18.63
Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56 Week 56: Side Effects	—	83.33 units on a scale	79.17 units on a scale Standard Deviation 5.89
Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56 Week 56: Convenience	69.93 units on a scale Standard Deviation 17.78	68.86 units on a scale Standard Deviation 16.14	68.60 units on a scale Standard Deviation 14.18
Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56 Week 56: Global Satisfaction	72.22 units on a scale Standard Deviation 20.25	72.29 units on a scale Standard Deviation 18.61	67.44 units on a scale Standard Deviation 15.19

SECONDARY outcome

Timeframe: Weeks 16 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

The mPRTI was a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. To assess participants willingness to use study drug again, participants responded using IRT on 5 point Likert scale ranged from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicated lesser willingness to use the study drug.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 16 · Yes, definitely want to use the same drug again	41 Participants	37 Participants	40 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 16 · Might want to use the same drug again	28 Participants	27 Participants	25 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 16 · I am not sure	18 Participants	25 Participants	21 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 16 · Might not want to use the same drug again	3 Participants	1 Participants	1 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 16 · No,definitely wouldn't want to use same drug again	2 Participants	0 Participants	1 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 56 · Yes, definitely want to use the same drug again	34 Participants	19 Participants	21 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 56 · Might want to use the same drug again	12 Participants	13 Participants	15 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 56 · I am not sure	16 Participants	10 Participants	6 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 56 · Might not want to use the same drug again	0 Participants	1 Participants	1 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again Week 56 · No,definitely wouldn't want to use same drug again	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 16 and 56

Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

The mPRTI was a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. To assess preference to continue using study drug versus previous treatment, participants responded using IRT on 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer drug that I am receiving now, 2= I have a slight preference for drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use study drug.

Outcome measures

Measure	Tanezumab 5 mg n=92 Participants Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 Participants Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 Participants Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 16 · Yes, definitely prefer the study drug	38 Participants	33 Participants	31 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 16 · Slight preference for the study drug	25 Participants	26 Participants	30 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 16 · No preference either way	22 Participants	28 Participants	23 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 16 · Slight preference for my previous treatment	6 Participants	2 Participants	3 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 16 · No, definitely prefer my previous treatment	1 Participants	1 Participants	1 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 56 · Yes, definitely prefer the study drug	33 Participants	21 Participants	19 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 56 · Slight preference for the study drug	15 Participants	14 Participants	16 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 56 · No preference either way	13 Participants	7 Participants	8 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 56 · Slight preference for my previous treatment	0 Participants	1 Participants	0 Participants
Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment Week 56 · No, definitely prefer my previous treatment	2 Participants	0 Participants	0 Participants

Adverse Events

Tanezumab 5 mg

Serious events: 8 serious events

Other events: 43 other events

Deaths: 0 deaths

Tanezumab 10 mg

Serious events: 11 serious events

Other events: 40 other events

Deaths: 0 deaths

Celecoxib

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tanezumab 5 mg n=92 participants at risk Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 participants at risk Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 participants at risk Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Endocrine disorders Basedow's disease	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Large intestine polyp	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Gastroenteritis	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Pyelonephritis acute	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Urinary tract infection	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Rapidly progressive osteoarthritis	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	2.2% 2/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	2.2% 2/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Cerebral infarction	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Sciatica	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Syncope	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Product Issues Device dislocation	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Chronic kidney disease	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Dysuria	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Asthma	1.1% 1/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Measure	Tanezumab 5 mg n=92 participants at risk Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Tanezumab 10 mg n=93 participants at risk Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).	Celecoxib n=92 participants at risk Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
General disorders Pyrexia	2.2% 2/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	2.2% 2/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.4% 5/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Nasopharyngitis	20.7% 19/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	20.4% 19/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	12.0% 11/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Contusion	5.4% 5/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.4% 5/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 3/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Fall	7.6% 7/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.5% 6/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.4% 5/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Arthralgia	12.0% 11/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.4% 5/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.6% 7/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Back pain	7.6% 7/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.5% 7/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.8% 9/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Pain in extremity	5.4% 5/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	2.2% 2/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.3% 4/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Periarthritis	6.5% 6/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.1% 1/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Hypoaesthesia	6.5% 6/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.2% 3/93 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.4% 5/92 • Baseline up to Week 80 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

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