Trial Outcomes & Findings for A Study of Tanezumab in Adults With Chronic Low Back Pain (NCT NCT00876187)

Last Updated: 2021-07-07

Results Overview

Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1359 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2021-07-07

Participant Flow

Participants underwent for a 5-day initial pain assessment period prior to randomization.

Participants who discontinued due to lack of efficacy or completed the treatment in this study were eligible to enroll in safety extension study A4091039 (NCT00924664).

Participant milestones

Participant milestones
Measure	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Overall Study STARTED	233	233	298	297	298
Overall Study Treated	230	232	295	295	295
Overall Study Completed Treatment	128	146	193	188	185
Overall Study COMPLETED	23	18	19	22	27
Overall Study NOT COMPLETED	210	215	279	275	271

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Overall Study Adverse Event	14	12	19	29	10
Overall Study Lack of Efficacy	59	34	45	34	59
Overall Study Lost to Follow-up	9	10	8	8	11
Overall Study Protocol Violation	6	7	7	6	3
Overall Study Withdrawal by Subject	16	26	32	38	37
Overall Study Entered extension study	101	120	156	151	144
Overall Study Randomized but not treated	3	1	3	2	3
Overall Study Other	2	5	9	7	4

Baseline Characteristics

A Study of Tanezumab in Adults With Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.	Total n=1347 Participants Total of all reporting groups
Age, Continuous	51.2 years STANDARD_DEVIATION 13.2 • n=93 Participants	51.5 years STANDARD_DEVIATION 14.2 • n=4 Participants	52.0 years STANDARD_DEVIATION 13.9 • n=27 Participants	51.2 years STANDARD_DEVIATION 12.9 • n=483 Participants	52.6 years STANDARD_DEVIATION 13.2 • n=36 Participants	51.8 years STANDARD_DEVIATION 13.5 • n=10 Participants
Sex: Female, Male Female	125 Participants n=93 Participants	115 Participants n=4 Participants	157 Participants n=27 Participants	165 Participants n=483 Participants	152 Participants n=36 Participants	714 Participants n=10 Participants
Sex: Female, Male Male	105 Participants n=93 Participants	117 Participants n=4 Participants	138 Participants n=27 Participants	130 Participants n=483 Participants	143 Participants n=36 Participants	633 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) Baseline	6.71 units on a scale Standard Deviation 1.37	6.62 units on a scale Standard Deviation 1.36	6.57 units on a scale Standard Deviation 1.39	6.74 units on a scale Standard Deviation 1.48	6.77 units on a scale Standard Deviation 1.38
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.25 units on a scale Standard Deviation 2.01	-1.55 units on a scale Standard Deviation 2.07	-2.02 units on a scale Standard Deviation 2.40	-2.19 units on a scale Standard Deviation 2.52	-1.70 units on a scale Standard Deviation 2.28

SECONDARY outcome

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

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

RMDQ: back-specific, participant administered questionnaire that assesses how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement if it describes his/her functional ability on the day of assessment. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements marked. Total possible RMDQ score: 0 (best functioning) to 24 (worst functioning), with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Placebo n=228 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Baseline	12.79 units on a scale Standard Deviation 4.74	12.24 units on a scale Standard Deviation 4.92	12.98 units on a scale Standard Deviation 5.11	13.00 units on a scale Standard Deviation 4.97	12.86 units on a scale Standard Deviation 4.93
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.68 units on a scale Standard Deviation 3.74	-2.47 units on a scale Standard Deviation 4.61	-2.59 units on a scale Standard Deviation 4.41	-2.39 units on a scale Standard Deviation 4.61	-2.28 units on a scale Standard Deviation 4.19
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.85 units on a scale Standard Deviation 4.04	-2.81 units on a scale Standard Deviation 4.52	-3.45 units on a scale Standard Deviation 4.90	-3.35 units on a scale Standard Deviation 4.87	-2.39 units on a scale Standard Deviation 4.24
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.86 units on a scale Standard Deviation 4.13	-2.62 units on a scale Standard Deviation 4.43	-2.93 units on a scale Standard Deviation 4.75	-3.47 units on a scale Standard Deviation 5.17	-2.27 units on a scale Standard Deviation 4.12
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.91 units on a scale Standard Deviation 4.13	-2.23 units on a scale Standard Deviation 3.82	-3.16 units on a scale Standard Deviation 4.97	-3.26 units on a scale Standard Deviation 4.81	-2.44 units on a scale Standard Deviation 4.12
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 16	-1.76 units on a scale Standard Deviation 4.15	-2.27 units on a scale Standard Deviation 4.07	-3.20 units on a scale Standard Deviation 5.07	-2.82 units on a scale Standard Deviation 4.65	-2.08 units on a scale Standard Deviation 3.85

SECONDARY outcome

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

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range:1 to 5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Outcome measures

Outcome measures
Measure	Placebo n=229 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=294 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 12	-0.48 units on a scale Standard Deviation 0.82	-0.69 units on a scale Standard Deviation 0.91	-0.73 units on a scale Standard Deviation 0.90	-0.74 units on a scale Standard Deviation 0.98	-0.59 units on a scale Standard Deviation 0.86
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Baseline	3.41 units on a scale Standard Deviation 0.58	3.41 units on a scale Standard Deviation 0.60	3.33 units on a scale Standard Deviation 0.56	3.36 units on a scale Standard Deviation 0.56	3.35 units on a scale Standard Deviation 0.56
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 2	-0.55 units on a scale Standard Deviation 0.80	-0.62 units on a scale Standard Deviation 0.91	-0.66 units on a scale Standard Deviation 0.89	-0.62 units on a scale Standard Deviation 1.00	-0.59 units on a scale Standard Deviation 0.84
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 4	-0.53 units on a scale Standard Deviation 0.88	-0.78 units on a scale Standard Deviation 0.89	-0.77 units on a scale Standard Deviation 0.90	-0.84 units on a scale Standard Deviation 0.95	-0.67 units on a scale Standard Deviation 0.90
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 8	-0.52 units on a scale Standard Deviation 0.84	-0.66 units on a scale Standard Deviation 0.93	-0.71 units on a scale Standard Deviation 0.92	-0.78 units on a scale Standard Deviation 0.93	-0.54 units on a scale Standard Deviation 0.87
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Change at Week 16	-0.42 units on a scale Standard Deviation 0.78	-0.59 units on a scale Standard Deviation 0.96	-0.63 units on a scale Standard Deviation 0.91	-0.67 units on a scale Standard Deviation 0.93	-0.49 units on a scale Standard Deviation 0.86

SECONDARY outcome

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

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) Change at Week 2	-1.29 units on scale Standard Deviation 1.84	-1.48 units on scale Standard Deviation 1.79	-1.83 units on scale Standard Deviation 1.89	-1.68 units on scale Standard Deviation 2.19	-1.85 units on scale Standard Deviation 1.98
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) Change at Week 4	-1.50 units on scale Standard Deviation 1.95	-1.94 units on scale Standard Deviation 2.00	-2.47 units on scale Standard Deviation 2.22	-2.44 units on scale Standard Deviation 2.33	-2.05 units on scale Standard Deviation 2.05
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) Change at Week 8	-1.40 units on scale Standard Deviation 2.05	-1.82 units on scale Standard Deviation 1.99	-2.23 units on scale Standard Deviation 2.25	-2.32 units on scale Standard Deviation 2.40	-1.82 units on scale Standard Deviation 2.05
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) Change at Week 12	-1.49 units on scale Standard Deviation 2.14	-1.92 units on scale Standard Deviation 2.17	-2.27 units on scale Standard Deviation 2.47	-2.37 units on scale Standard Deviation 2.56	-1.93 units on scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Participants with specified reduction (as percent) from baseline at Week 16 are reported.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) Greater than (>) 0%	103 Participants	121 Participants	171 Participants	174 Participants	160 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) Greater than or equal to (>=)10%	90 Participants	111 Participants	159 Participants	162 Participants	146 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) >= 20%	78 Participants	99 Participants	136 Participants	145 Participants	128 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) >= 30%	62 Participants	83 Participants	123 Participants	137 Participants	111 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) >= 40%	53 Participants	64 Participants	112 Participants	120 Participants	92 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) >= 50%	39 Participants	59 Participants	94 Participants	104 Participants	78 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) >= 60%	31 Participants	42 Participants	78 Participants	80 Participants	60 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) >= 70%	22 Participants	29 Participants	62 Participants	54 Participants	37 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) >= 80%	12 Participants	24 Participants	45 Participants	40 Participants	26 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) >= 90%	8 Participants	12 Participants	30 Participants	26 Participants	16 Participants
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) = 100%	5 Participants	9 Participants	20 Participants	16 Participants	9 Participants

SECONDARY outcome

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

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 2: >=30% reduction	27.4 percentage of participants	32.8 percentage of participants	42.4 percentage of participants	41.0 percentage of participants	39.0 percentage of participants
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 2: >=50% reduction	11.3 percentage of participants	20.7 percentage of participants	19.3 percentage of participants	22.0 percentage of participants	24.4 percentage of participants
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 4: >=30% reduction	33.9 percentage of participants	43.5 percentage of participants	54.2 percentage of participants	52.5 percentage of participants	42.0 percentage of participants
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 4: >=50% reduction	16.5 percentage of participants	28.9 percentage of participants	35.6 percentage of participants	35.9 percentage of participants	25.8 percentage of participants
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 8: >=30% reduction	32.2 percentage of participants	43.1 percentage of participants	48.1 percentage of participants	50.8 percentage of participants	39.7 percentage of participants
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 8: >=50% reduction	18.7 percentage of participants	25.4 percentage of participants	32.5 percentage of participants	35.3 percentage of participants	22.7 percentage of participants
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 12: >=30% reduction	31.3 percentage of participants	42.7 percentage of participants	48.1 percentage of participants	50.5 percentage of participants	42.7 percentage of participants
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 12: >=50% reduction	22.2 percentage of participants	31.0 percentage of participants	36.3 percentage of participants	40.0 percentage of participants	30.8 percentage of participants
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 16: >=30% reduction	27.0 percentage of participants	35.8 percentage of participants	41.7 percentage of participants	46.4 percentage of participants	37.6 percentage of participants
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) Week 16: >=50% reduction	17.0 percentage of participants	25.4 percentage of participants	31.9 percentage of participants	35.3 percentage of participants	26.4 percentage of participants

SECONDARY outcome

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

BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain, each with a score range: 0 (no pain) and 10 (pain as bad as you can imagine), higher scores indicated worse pain.

Outcome measures

Outcome measures
Measure	Placebo n=228 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=294 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Baseline: Worst Pain	7.27 units on a scale Standard Deviation 1.51	7.10 units on a scale Standard Deviation 1.53	7.04 units on a scale Standard Deviation 1.49	7.36 units on a scale Standard Deviation 1.59	7.28 units on a scale Standard Deviation 1.51
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Baseline: Average Pain	6.22 units on a scale Standard Deviation 1.44	6.25 units on a scale Standard Deviation 1.51	6.08 units on a scale Standard Deviation 1.52	6.35 units on a scale Standard Deviation 1.45	6.27 units on a scale Standard Deviation 1.41
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 2: Worst Pain	-1.63 units on a scale Standard Deviation 2.33	-1.76 units on a scale Standard Deviation 2.14	-2.19 units on a scale Standard Deviation 2.41	-2.08 units on a scale Standard Deviation 2.60	-1.97 units on a scale Standard Deviation 2.38
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 2: Average Pain	-1.16 units on a scale Standard Deviation 1.93	-1.43 units on a scale Standard Deviation 1.91	-1.69 units on a scale Standard Deviation 2.11	-1.65 units on a scale Standard Deviation 2.34	-1.57 units on a scale Standard Deviation 2.07
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 4: Worst Pain	-1.63 units on a scale Standard Deviation 2.38	-2.21 units on a scale Standard Deviation 2.28	-2.57 units on a scale Standard Deviation 2.50	-2.88 units on a scale Standard Deviation 2.64	-2.16 units on a scale Standard Deviation 2.50
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 4: Average Pain	-1.19 units on a scale Standard Deviation 1.95	-1.88 units on a scale Standard Deviation 1.91	-2.09 units on a scale Standard Deviation 2.18	-2.32 units on a scale Standard Deviation 2.34	-1.77 units on a scale Standard Deviation 2.10
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 8: Worst Pain	-1.54 units on a scale Standard Deviation 2.33	-1.94 units on a scale Standard Deviation 2.30	-2.35 units on a scale Standard Deviation 2.45	-2.55 units on a scale Standard Deviation 2.70	-1.98 units on a scale Standard Deviation 2.31
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 8: Average Pain	-1.19 units on a scale Standard Deviation 1.93	-1.78 units on a scale Standard Deviation 1.99	-1.98 units on a scale Standard Deviation 2.18	-2.18 units on a scale Standard Deviation 2.42	-1.61 units on a scale Standard Deviation 1.97
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 12: Worst Pain	-1.63 units on a scale Standard Deviation 2.43	-1.99 units on a scale Standard Deviation 2.41	-2.53 units on a scale Standard Deviation 2.73	-2.70 units on a scale Standard Deviation 2.84	-2.13 units on a scale Standard Deviation 2.55
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 12: Average Pain	-1.32 units on a scale Standard Deviation 2.12	-1.75 units on a scale Standard Deviation 2.11	-2.13 units on a scale Standard Deviation 2.35	-2.26 units on a scale Standard Deviation 2.54	-1.73 units on a scale Standard Deviation 2.13
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 16: Worst Pain	-1.55 units on a scale Standard Deviation 2.35	-1.75 units on a scale Standard Deviation 2.34	-2.20 units on a scale Standard Deviation 2.66	-2.36 units on a scale Standard Deviation 2.78	-1.94 units on a scale Standard Deviation 2.49
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) Change at Week 16: Average Pain	-1.20 units on a scale Standard Deviation 1.95	-1.58 units on a scale Standard Deviation 2.14	-1.89 units on a scale Standard Deviation 2.37	-2.03 units on a scale Standard Deviation 2.47	-1.66 units on a scale Standard Deviation 2.19

SECONDARY outcome

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

Population: ITT analysis set. BOCF method was used to impute missing values. Here, "Overall number of participants analyzed" = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively.

BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure pain interference (PI) on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes); higher score = greater impairment. The 7 items in Q5 averaged to obtain pain interference index (function composite score), range: 0 (no interference) to 10 (complete interference); higher score = greater impairment.

Outcome measures

Outcome measures
Measure	Placebo n=228 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=231 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 4: Walking Ability	-1.48 units on a scale Standard Deviation 2.71	-1.91 units on a scale Standard Deviation 2.59	-2.32 units on a scale Standard Deviation 2.59	-2.58 units on a scale Standard Deviation 2.88	-2.00 units on a scale Standard Deviation 2.63
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 2: Pain Interference Index	-1.33 units on a scale Standard Deviation 2.20	-1.59 units on a scale Standard Deviation 2.14	-1.97 units on a scale Standard Deviation 2.33	-1.81 units on a scale Standard Deviation 2.63	-1.75 units on a scale Standard Deviation 2.46
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 4: Pain Interference Index	-1.48 units on a scale Standard Deviation 2.19	-1.99 units on a scale Standard Deviation 2.12	-2.40 units on a scale Standard Deviation 2.31	-2.63 units on a scale Standard Deviation 2.44	-2.01 units on a scale Standard Deviation 2.34
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 12: Pain Interference Index	-1.38 units on a scale Standard Deviation 2.19	-1.62 units on a scale Standard Deviation 2.21	-2.21 units on a scale Standard Deviation 2.47	-2.38 units on a scale Standard Deviation 2.60	-1.81 units on a scale Standard Deviation 2.39
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 16: Pain Interference Index	-1.32 units on a scale Standard Deviation 2.01	-1.52 units on a scale Standard Deviation 2.19	-2.02 units on a scale Standard Deviation 2.48	-2.17 units on a scale Standard Deviation 2.44	-1.59 units on a scale Standard Deviation 2.28
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 8: Pain Interference Index	-1.33 units on a scale Standard Deviation 2.20	-1.65 units on a scale Standard Deviation 2.16	-2.15 units on a scale Standard Deviation 2.34	-2.37 units on a scale Standard Deviation 2.45	-1.71 units on a scale Standard Deviation 2.22
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 2: General Activity	-1.30 units on a scale Standard Deviation 2.58	-1.72 units on a scale Standard Deviation 2.51	-2.20 units on a scale Standard Deviation 2.75	-2.06 units on a scale Standard Deviation 3.00	-1.92 units on a scale Standard Deviation 2.72
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 4: General Activity	-1.33 units on a scale Standard Deviation 2.55	-2.17 units on a scale Standard Deviation 2.42	-2.64 units on a scale Standard Deviation 2.59	-2.90 units on a scale Standard Deviation 2.84	-2.08 units on a scale Standard Deviation 2.72
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 8: General Activity	-1.36 units on a scale Standard Deviation 2.57	-1.70 units on a scale Standard Deviation 2.52	-2.27 units on a scale Standard Deviation 2.63	-2.53 units on a scale Standard Deviation 2.76	-1.77 units on a scale Standard Deviation 2.64
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 12: General Activity	-1.43 units on a scale Standard Deviation 2.54	-1.76 units on a scale Standard Deviation 2.54	-2.39 units on a scale Standard Deviation 2.73	-2.62 units on a scale Standard Deviation 2.87	-1.90 units on a scale Standard Deviation 2.68
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 16: General Activity	-1.34 units on a scale Standard Deviation 2.21	-1.68 units on a scale Standard Deviation 2.55	-2.20 units on a scale Standard Deviation 2.76	-2.26 units on a scale Standard Deviation 2.71	-1.65 units on a scale Standard Deviation 2.56
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 2: Walking Ability	-1.29 units on a scale Standard Deviation 2.71	-1.59 units on a scale Standard Deviation 2.52	-1.83 units on a scale Standard Deviation 2.69	-1.81 units on a scale Standard Deviation 2.94	-1.73 units on a scale Standard Deviation 2.71
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 8: Walking Ability	-1.24 units on a scale Standard Deviation 2.56	-1.62 units on a scale Standard Deviation 2.47	-2.01 units on a scale Standard Deviation 2.66	-2.36 units on a scale Standard Deviation 2.88	-1.72 units on a scale Standard Deviation 2.52
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 12: Walking Ability	-1.28 units on a scale Standard Deviation 2.41	-1.63 units on a scale Standard Deviation 2.50	-2.13 units on a scale Standard Deviation 2.68	-2.34 units on a scale Standard Deviation 2.82	-1.80 units on a scale Standard Deviation 2.55
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 16: Walking Ability	-1.17 units on a scale Standard Deviation 2.16	-1.49 units on a scale Standard Deviation 2.29	-1.91 units on a scale Standard Deviation 2.71	-2.14 units on a scale Standard Deviation 2.72	-1.53 units on a scale Standard Deviation 2.52
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 2: Normal Work	-1.33 units on a scale Standard Deviation 2.37	-1.75 units on a scale Standard Deviation 2.57	-2.01 units on a scale Standard Deviation 2.61	-2.01 units on a scale Standard Deviation 2.90	-1.67 units on a scale Standard Deviation 2.67
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 4: Normal Work	-1.59 units on a scale Standard Deviation 2.36	-2.03 units on a scale Standard Deviation 2.49	-2.49 units on a scale Standard Deviation 2.57	-2.79 units on a scale Standard Deviation 2.75	-2.03 units on a scale Standard Deviation 2.55
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 8: Normal Work	-1.31 units on a scale Standard Deviation 2.35	-1.72 units on a scale Standard Deviation 2.46	-2.25 units on a scale Standard Deviation 2.64	-2.58 units on a scale Standard Deviation 2.75	-1.76 units on a scale Standard Deviation 2.49
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 12: Normal Work	-1.43 units on a scale Standard Deviation 2.25	-1.76 units on a scale Standard Deviation 2.43	-2.35 units on a scale Standard Deviation 2.75	-2.57 units on a scale Standard Deviation 2.85	-1.85 units on a scale Standard Deviation 2.65
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 16: Normal Work	-1.27 units on a scale Standard Deviation 2.15	-1.55 units on a scale Standard Deviation 2.45	-2.09 units on a scale Standard Deviation 2.74	-2.40 units on a scale Standard Deviation 2.76	-1.65 units on a scale Standard Deviation 2.47
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 2: Pain Interference with Sleep	-1.4 units on a scale Standard Deviation 2.72	-1.7 units on a scale Standard Deviation 2.58	-2.0 units on a scale Standard Deviation 2.89	-1.7 units on a scale Standard Deviation 3.09	-2.2 units on a scale Standard Deviation 2.90
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 4: Pain Interference with Sleep	-1.6 units on a scale Standard Deviation 2.52	-2.3 units on a scale Standard Deviation 2.62	-2.6 units on a scale Standard Deviation 2.87	-2.7 units on a scale Standard Deviation 2.89	-2.2 units on a scale Standard Deviation 2.72
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 8: Pain Interference with Sleep	-1.4 units on a scale Standard Deviation 2.54	-1.9 units on a scale Standard Deviation 2.62	-2.4 units on a scale Standard Deviation 2.86	-2.4 units on a scale Standard Deviation 2.83	-1.9 units on a scale Standard Deviation 2.54
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 12: Pain Interference with Sleep	-1.5 units on a scale Standard Deviation 2.49	-1.8 units on a scale Standard Deviation 2.69	-2.4 units on a scale Standard Deviation 3.04	-2.5 units on a scale Standard Deviation 3.00	-2.0 units on a scale Standard Deviation 2.66
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF Change at Week 16: Pain Interference with Sleep	-1.4 units on a scale Standard Deviation 2.29	-1.7 units on a scale Standard Deviation 2.66	-2.3 units on a scale Standard Deviation 3.04	-2.3 units on a scale Standard Deviation 2.82	-1.8 units on a scale Standard Deviation 2.60

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication.

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

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Time to Discontinuation Due to Lack of Efficacy	NA days Median and full range cannot be estimated due to less number of participants with events.	NA days Median and full range cannot be estimated due to less number of participants with events.	NA days Median and full range cannot be estimated due to less number of participants with events.	NA days Median and full range cannot be estimated due to less number of participants with events.	NA days Median and full range cannot be estimated due to less number of participants with events.

SECONDARY outcome

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

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.

Chronic Low Back Pain (CLBP) Responder Index: A response was defined as reduction of at least 30% in mean daily average LBPI from baseline to a specified week, decrease of at least 30% in PGA of low back pain from baseline to the specified week and no worsening (increase) in RMDQ total score from baseline to the specified week. Participants who were responders were reported.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) Week 2	38 participants	48 participants	77 participants	80 participants	69 participants
Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) Week 4	52 participants	70 participants	114 participants	113 participants	79 participants
Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) Week 8	40 participants	62 participants	96 participants	103 participants	64 participants
Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) Week 12	45 participants	60 participants	104 participants	105 participants	83 participants
Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) Week 16	44 participants	52 participants	90 participants	89 participants	63 participants

SECONDARY outcome

Timeframe: Baseline, Week 8, 16

Population: ITT analysis set. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

WPAI:SHP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Four scores are derived as percent: activity impairment (AI), impairment while working (IW), overall work impairment (OWI), work time missed (WTM). Each of 4 scores expressed as impairment percentages with a total possible score range of 0 to 100, high percentage= more impairment, less productivity.

Outcome measures

Outcome measures
Measure	Placebo n=229 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Baseline: Activity Impairment	58.77 percentage of impairment Standard Deviation 22.88	55.15 percentage of impairment Standard Deviation 22.63	59.32 percentage of impairment Standard Deviation 21.48	60.81 percentage of impairment Standard Deviation 20.74	59.97 percentage of impairment Standard Deviation 21.27
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Baseline: Impairment While Working	49.19 percentage of impairment Standard Deviation 24.85	45.17 percentage of impairment Standard Deviation 23.51	49.15 percentage of impairment Standard Deviation 22.11	49.62 percentage of impairment Standard Deviation 26.01	48.90 percentage of impairment Standard Deviation 24.16
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Baseline: Overall Work Impairment	6.29 percentage of impairment Standard Deviation 21.06	6.68 percentage of impairment Standard Deviation 21.61	7.51 percentage of impairment Standard Deviation 21.18	10.71 percentage of impairment Standard Deviation 26.29	8.30 percentage of impairment Standard Deviation 23.43
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Baseline: Work Time Missed	1.97 percentage of impairment Standard Deviation 8.69	3.17 percentage of impairment Standard Deviation 12.03	2.02 percentage of impairment Standard Deviation 7.22	3.82 percentage of impairment Standard Deviation 11.50	3.26 percentage of impairment Standard Deviation 11.79
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Change at Week 8: Activity Impairment	-14.58 percentage of impairment Standard Deviation 24.31	-15.80 percentage of impairment Standard Deviation 25.16	-24.96 percentage of impairment Standard Deviation 26.32	-27.08 percentage of impairment Standard Deviation 28.65	-18.53 percentage of impairment Standard Deviation 24.08
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Change at Week 8: Impairment While Working	-14.79 percentage of impairment Standard Deviation 24.79	-10.75 percentage of impairment Standard Deviation 25.42	-21.98 percentage of impairment Standard Deviation 25.54	-19.21 percentage of impairment Standard Deviation 45.39	-16.70 percentage of impairment Standard Deviation 23.23
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Change at Week 8: Overall Work Impairment	0.43 percentage of impairment Standard Deviation 21.56	0.08 percentage of impairment Standard Deviation 19.74	-3.83 percentage of impairment Standard Deviation 22.24	-6.64 percentage of impairment Standard Deviation 24.52	-4.58 percentage of impairment Standard Deviation 20.24
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Change at Week 8: Work Time Missed	0.58 percentage of impairment Standard Deviation 8.78	0.16 percentage of impairment Standard Deviation 9.53	-0.38 percentage of impairment Standard Deviation 9.12	-2.15 percentage of impairment Standard Deviation 12.35	-1.74 percentage of impairment Standard Deviation 9.25
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Change at Week 16: Activity Impairment	-22.50 percentage of impairment Standard Deviation 24.11	-19.45 percentage of impairment Standard Deviation 25.51	-29.95 percentage of impairment Standard Deviation 27.08	-31.79 percentage of impairment Standard Deviation 25.78	-24.28 percentage of impairment Standard Deviation 24.62
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Change at Week 16: Impairment While Working	-20.60 percentage of impairment Standard Deviation 22.56	-15.22 percentage of impairment Standard Deviation 24.05	-27.65 percentage of impairment Standard Deviation 26.17	-24.57 percentage of impairment Standard Deviation 26.34	-21.05 percentage of impairment Standard Deviation 24.54
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Change at Week 16:Overall Work Impairment	-2.52 percentage of impairment Standard Deviation 14.15	-1.72 percentage of impairment Standard Deviation 15.37	-3.92 percentage of impairment Standard Deviation 24.38	-7.71 percentage of impairment Standard Deviation 24.10	-6.68 percentage of impairment Standard Deviation 22.62
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 Change at Week 16:Work Time Missed	-0.79 percentage of impairment Standard Deviation 6.67	-0.09 percentage of impairment Standard Deviation 7.49	-0.24 percentage of impairment Standard Deviation 11.20	-2.98 percentage of impairment Standard Deviation 10.69	-2.30 percentage of impairment Standard Deviation 11.60

SECONDARY outcome

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

Population: ITT analysis set. LOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=293 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=292 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=294 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Percentage of Participants Who Used Rescue Medications Week 2	70.3 percentage of participants	69.7 percentage of participants	74.1 percentage of participants	73.4 percentage of participants	60.8 percentage of participants
Percentage of Participants Who Used Rescue Medications Week 4	63.9 percentage of participants	53.9 percentage of participants	54.3 percentage of participants	53.4 percentage of participants	53.2 percentage of participants
Percentage of Participants Who Used Rescue Medications Week 8	54.8 percentage of participants	49.6 percentage of participants	50.9 percentage of participants	47.6 percentage of participants	48.3 percentage of participants
Percentage of Participants Who Used Rescue Medications Week 12	40.4 percentage of participants	40.5 percentage of participants	45.1 percentage of participants	38.7 percentage of participants	44.6 percentage of participants
Percentage of Participants Who Used Rescue Medications Week 16	42.6 percentage of participants	41.4 percentage of participants	43.0 percentage of participants	38.0 percentage of participants	41.2 percentage of participants

SECONDARY outcome

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

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=293 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=292 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=294 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Duration of Rescue Medication Use Week 2	2.0 days/week Interval 0.0 to 7.0	2.0 days/week Interval 0.0 to 7.0	2.0 days/week Interval 0.0 to 7.0	2.0 days/week Interval 0.0 to 7.0	1.0 days/week Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 4	2.0 days/week Interval 0.0 to 7.0	1.0 days/week Interval 0.0 to 7.0	1.0 days/week Interval 0.0 to 7.0	1.0 days/week Interval 0.0 to 7.0	1.0 days/week Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 8	1.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0	1.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 12	0.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 16	0.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0	0.0 days/week Interval 0.0 to 7.0

SECONDARY outcome

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

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=293 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=292 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=294 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Amount of Rescue Medication Taken Week 12	2619.57 mg per week Standard Deviation 5350.37	2256.47 mg per week Standard Deviation 4350.69	2511.95 mg per week Standard Deviation 4164.31	2351.03 mg per week Standard Deviation 4297.87	2455.78 mg per week Standard Deviation 4580.69
Amount of Rescue Medication Taken Week 2	4168.12 mg per week Standard Deviation 4708.74	4305.19 mg per week Standard Deviation 5102.74	3952.22 mg per week Standard Deviation 4527.82	4306.90 mg per week Standard Deviation 4880.47	3350.52 mg per week Standard Deviation 4564.20
Amount of Rescue Medication Taken Week 4	3547.83 mg per week Standard Deviation 4860.04	3252.16 mg per week Standard Deviation 5189.48	2583.62 mg per week Standard Deviation 3966.56	2688.36 mg per week Standard Deviation 4314.58	2680.89 mg per week Standard Deviation 4120.78
Amount of Rescue Medication Taken Week 8	2910.87 mg per week Standard Deviation 4483.80	2633.62 mg per week Standard Deviation 4309.14	2829.35 mg per week Standard Deviation 4458.51	2558.22 mg per week Standard Deviation 4232.71	2477.89 mg per week Standard Deviation 4270.55
Amount of Rescue Medication Taken Week 16	2523.91 mg per week Standard Deviation 4493.14	2140.09 mg per week Standard Deviation 4167.33	2250.85 mg per week Standard Deviation 3979.75	2369.86 mg per week Standard Deviation 4417.07	2448.98 mg per week Standard Deviation 4677.93

SECONDARY outcome

Timeframe: Baseline, Week 8, 16, 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

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

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 Baseline	0.97 units on a scale Standard Deviation 2.68	1.16 units on a scale Standard Deviation 3.04	1.03 units on a scale Standard Deviation 2.79	1.31 units on a scale Standard Deviation 4.75	1.02 units on a scale Standard Deviation 2.82
Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 Change at Week 8	-0.15 units on a scale Standard Deviation 1.43	-0.41 units on a scale Standard Deviation 2.79	-0.09 units on a scale Standard Deviation 1.49	-0.38 units on a scale Standard Deviation 3.61	-0.06 units on a scale Standard Deviation 1.14
Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 Change at Week 16	-0.30 units on a scale Standard Deviation 1.67	-0.27 units on a scale Standard Deviation 1.96	0.05 units on a scale Standard Deviation 1.36	0.02 units on a scale Standard Deviation 1.63	-0.18 units on a scale Standard Deviation 1.43
Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 Change at Week 24	-0.74 units on a scale Standard Deviation 3.47	-0.15 units on a scale Standard Deviation 1.09	0.10 units on a scale Standard Deviation 1.04	-0.46 units on a scale Standard Deviation 1.22	-0.48 units on a scale Standard Deviation 1.48

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 8, 16, 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here, "Overall number of participants analyzed" = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively

Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.

Outcome measures

Outcome measures
Measure	Placebo n=226 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=288 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=289 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Number of Participants Who Developed Anti-Tanezumab Antibodies Baseline	0 Participants	1 Participants	0 Participants	—	—
Number of Participants Who Developed Anti-Tanezumab Antibodies Week 8	0 Participants	0 Participants	0 Participants	—	—
Number of Participants Who Developed Anti-Tanezumab Antibodies Week 16	0 Participants	1 Participants	1 Participants	—	—
Number of Participants Who Developed Anti-Tanezumab Antibodies Week 24	0 Participants	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit

Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.

Outcome measures

Outcome measures
Measure	Placebo n=225 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=288 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=288 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Plasma Concentration of Tanezumab Baseline: pre-dose	70.7627 nanogram per milliliter Standard Deviation 315.3581	60.2354 nanogram per milliliter Standard Deviation 383.8924	40.9396 nanogram per milliliter Standard Deviation 317.3858	—	—
Plasma Concentration of Tanezumab Baseline: 1 hr post-dose	1944.46 nanogram per milliliter Standard Deviation 572.9289	4105.46 nanogram per milliliter Standard Deviation 1495.906	8460.14 nanogram per milliliter Standard Deviation 2983.547	—	—
Plasma Concentration of Tanezumab Week 4	472.248 nanogram per milliliter Standard Deviation 238.5394	983.377 nanogram per milliliter Standard Deviation 346.1361	1983.72 nanogram per milliliter Standard Deviation 598.7860	—	—
Plasma Concentration of Tanezumab Week 8: pre-dose	240.405 nanogram per milliliter Standard Deviation 333.2990	442.843 nanogram per milliliter Standard Deviation 208.6190	1081.69 nanogram per milliliter Standard Deviation 997.0692	—	—
Plasma Concentration of Tanezumab Week 8: 1 hr post-dose	2026.01 nanogram per milliliter Standard Deviation 693.5790	4637.82 nanogram per milliliter Standard Deviation 2630.921	9161.84 nanogram per milliliter Standard Deviation 4274.392	—	—
Plasma Concentration of Tanezumab Week 16	239.804 nanogram per milliliter Standard Deviation 245.3006	531.014 nanogram per milliliter Standard Deviation 256.1994	1393.40 nanogram per milliliter Standard Deviation 1219.270	—	—
Plasma Concentration of Tanezumab Week 24	276.991 nanogram per milliliter Standard Deviation 402.0603	636.217 nanogram per milliliter Standard Deviation 567.9855	1222.17 nanogram per milliliter Standard Deviation 1105.125	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit

Outcome measures

Outcome measures
Measure	Placebo n=209 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=216 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=277 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=268 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=266 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Total Nerve Growth Factor (NGF) Concentration Week 4	92.33 picogram per mL Standard Deviation 655.1	3217.6 picogram per mL Standard Deviation 1134	3981.7 picogram per mL Standard Deviation 1362	4456.7 picogram per mL Standard Deviation 1325	38.17 picogram per mL Standard Deviation 16.11
Total Nerve Growth Factor (NGF) Concentration Baseline: pre-dose	34.65 picogram per mL Standard Deviation 11.68	44.38 picogram per mL Standard Deviation 49.12	55.66 picogram per mL Standard Deviation 202.0	61.79 picogram per mL Standard Deviation 220.7	35.50 picogram per mL Standard Deviation 12.38
Total Nerve Growth Factor (NGF) Concentration Baseline: 1 hr post-dose	37.90 picogram per mL Standard Deviation 11.99	96.76 picogram per mL Standard Deviation 35.08	113.33 picogram per mL Standard Deviation 251.5	126.50 picogram per mL Standard Deviation 192.8	40.30 picogram per mL Standard Deviation 13.10
Total Nerve Growth Factor (NGF) Concentration Week 8: pre-dose	126.66 picogram per mL Standard Deviation 707.6	2671.7 picogram per mL Standard Deviation 1249	3624.7 picogram per mL Standard Deviation 1398	4238.6 picogram per mL Standard Deviation 1604	41.47 picogram per mL Standard Deviation 80.11
Total Nerve Growth Factor (NGF) Concentration Week 8: 1 hr post-dose	124.71 picogram per mL Standard Deviation 750.3	2943.5 picogram per mL Standard Deviation 1334	3950.9 picogram per mL Standard Deviation 1479	4929.1 picogram per mL Standard Deviation 1775	69.74 picogram per mL Standard Deviation 241.8
Total Nerve Growth Factor (NGF) Concentration Week 16	41.96 picogram per mL Standard Deviation 23.56	3263.0 picogram per mL Standard Deviation 1539	4490.5 picogram per mL Standard Deviation 1953	5842.2 picogram per mL Standard Deviation 2377	135.17 picogram per mL Standard Deviation 810.2
Total Nerve Growth Factor (NGF) Concentration Week 24	226.61 picogram per mL Standard Deviation 916.4	2602.0 picogram per mL Standard Deviation 1486	3549.5 picogram per mL Standard Deviation 1747	4420.3 picogram per mL Standard Deviation 1776	38.77 picogram per mL Standard Deviation 15.66

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication.

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

Outcome measures

Outcome measures
Measure	Placebo n=230 Participants Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 Participants Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 Participants Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 Participants Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 Participants Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	120 Participants	141 Participants	171 Participants	190 Participants	142 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	5 Participants	4 Participants	3 Participants	3 Participants	5 Participants

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 74 other events

Deaths: 0 deaths

Tanezumab 5 mg

Serious events: 4 serious events

Other events: 80 other events

Deaths: 0 deaths

Tanezumab 10 mg

Serious events: 3 serious events

Other events: 114 other events

Deaths: 0 deaths

Tanezumab 20 mg

Serious events: 3 serious events

Other events: 134 other events

Deaths: 0 deaths

Naproxen 500 mg

Serious events: 5 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=230 participants at risk Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 participants at risk Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 participants at risk Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 participants at risk Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 participants at risk Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Infections and infestations Pneumonia	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.43% 1/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Eye injury	0.43% 1/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.43% 1/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.43% 1/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Burning sensation	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsion	0.43% 1/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.43% 1/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicide attempt	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Calculus ureteric	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.43% 1/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Deep vein thrombosis	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.43% 1/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure congestive	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.43% 1/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Non-cardiac chest pain	0.87% 2/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.43% 1/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Placebo n=230 participants at risk Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 5 mg n=232 participants at risk Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 10 mg n=295 participants at risk Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Tanezumab 20 mg n=295 participants at risk Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.	Naproxen 500 mg n=295 participants at risk Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
Gastrointestinal disorders Diarrhoea	2.6% 6/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 5/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 8/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 8/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 4/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.87% 2/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.6% 6/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 6/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 12/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 9/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	0.87% 2/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 4/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 7/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 10/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	2.6% 6/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 5/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.68% 2/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 4/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	2.2% 5/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.6% 6/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 4/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	0.87% 2/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 4/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 10/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 13/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 9/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	2.2% 5/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 5/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 7/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 4/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	4.3% 10/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.3% 10/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 10/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 10/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 12/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	3.5% 8/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 5/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 6/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 11/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 5/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	1.3% 3/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 3/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 6/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 5/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 7/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 4/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.9% 9/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.8% 26/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.5% 31/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 4/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint swelling	0.87% 2/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.86% 2/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 7/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.87% 2/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 9/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 7/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.68% 2/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.0% 7/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.86% 2/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 4/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.86% 2/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 7/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 6/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 3/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.6% 6/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 20/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.4% 19/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.68% 2/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	3.0% 7/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 5/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.68% 2/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 4/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 4/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysaesthesia	0.87% 2/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.86% 2/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 8/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	3.9% 9/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.2% 12/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 7/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 13/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 11/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hyperaesthesia	0.87% 2/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.86% 2/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 7/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 12/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypoaesthesia	2.6% 6/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 5/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 9/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 10/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 8/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	2.2% 5/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.7% 11/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 21/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.9% 38/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 5/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	0.43% 1/230 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.43% 1/232 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 3/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.34% 1/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 8/295 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER