Trial Outcomes & Findings for A Phase 3 Study of Tanezumab for Chronic Low Back Pain (NCT NCT02528253)
NCT ID: NCT02528253
Last Updated: 2020-02-21
Results Overview
Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1832 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2020-02-21
Participant Flow
A total of 1832 participants were enrolled in the study, however, only those participants were included in participant flow section who received at least 1 dose of study drug.
Treatment period was up to Week 56. Safety follow up period started at Week 64, thus Weeks 64 and 80 time points were during safety follow up period. Percentage (%) reduction in low back pain intensity (LBPI) and participants global assessment (PGA) 2-point reduction are efficacy measures and not applicable during safety follow up.
Participant milestones
| Measure |
Placebo Followed by Tanezumab 5 mg
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously (SC) once every 8 weeks and placebo tablets matched to tramadol prolonged release (PR), orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria (greater than equal to \[\>=\] 30 percent \[%\] reduction in average LBPI score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 milligram (mg), SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Placebo Followed by Tanezumab 10 mg
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria, then received tanezumab 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
205
|
204
|
407
|
407
|
602
|
|
Overall Study
Intent to Treat Population
|
202
|
204
|
407
|
407
|
605
|
|
Overall Study
Treated at Week 16
|
99
|
95
|
236
|
242
|
307
|
|
Overall Study
COMPLETED
|
130
|
134
|
267
|
271
|
379
|
|
Overall Study
NOT COMPLETED
|
75
|
70
|
140
|
136
|
223
|
Reasons for withdrawal
| Measure |
Placebo Followed by Tanezumab 5 mg
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously (SC) once every 8 weeks and placebo tablets matched to tramadol prolonged release (PR), orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria (greater than equal to \[\>=\] 30 percent \[%\] reduction in average LBPI score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 milligram (mg), SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Placebo Followed by Tanezumab 10 mg
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria, then received tanezumab 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
4
|
8
|
18
|
|
Overall Study
Death
|
2
|
2
|
1
|
0
|
1
|
|
Overall Study
Insufficient clinical response
|
7
|
10
|
13
|
12
|
16
|
|
Overall Study
Lost to Follow-up
|
16
|
9
|
31
|
16
|
34
|
|
Overall Study
Other
|
21
|
22
|
58
|
52
|
76
|
|
Overall Study
Withdrawal by Subject
|
25
|
20
|
29
|
48
|
73
|
|
Overall Study
Protocol Violation
|
1
|
2
|
4
|
0
|
4
|
|
Overall Study
Withdrawn Due to Pregnancy
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 3 Study of Tanezumab for Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Placebo Followed by Tanezumab 5 mg
n=205 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria \>=30 percent \[%\] reduction in average LBPI score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 milligram (mg), SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Placebo Followed by Tanezumab 10 mg
n=204 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria, then received tanezumab 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Total
n=1825 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Age, Continuous
|
49.01 years
STANDARD_DEVIATION 13.76 • n=39 Participants
|
48.97 years
STANDARD_DEVIATION 12.00 • n=41 Participants
|
48.66 years
STANDARD_DEVIATION 12.36 • n=35 Participants
|
49.15 years
STANDARD_DEVIATION 12.36 • n=31 Participants
|
48.42 years
STANDARD_DEVIATION 13.08 • n=146 Participants
|
48.77 years
STANDARD_DEVIATION 12.72 • n=19 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=39 Participants
|
113 Participants
n=41 Participants
|
248 Participants
n=35 Participants
|
218 Participants
n=31 Participants
|
339 Participants
n=146 Participants
|
1041 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=39 Participants
|
91 Participants
n=41 Participants
|
159 Participants
n=35 Participants
|
189 Participants
n=31 Participants
|
263 Participants
n=146 Participants
|
784 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
White
|
154 Participants
n=39 Participants
|
142 Participants
n=41 Participants
|
295 Participants
n=35 Participants
|
303 Participants
n=31 Participants
|
428 Participants
n=146 Participants
|
1322 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
35 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
66 Participants
n=31 Participants
|
102 Participants
n=146 Participants
|
303 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
28 Participants
n=31 Participants
|
65 Participants
n=146 Participants
|
170 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
30 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: ITT population:randomized participants who received at least 1 dose of SC study medication(either tanezumab or matching placebo).Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16
|
-2.68 units on a scale
Standard Error 0.15
|
-2.98 units on a scale
Standard Error 0.14
|
-3.08 units on a scale
Standard Error 0.14
|
-2.81 units on a scale
Standard Error 0.12
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population:randomized participants who received at least 1 dose of SC study medication(either tanezumab or matching placebo).Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ from the total number of items checked ranged from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo
|
-4.95 units on a scale
Standard Error 0.36
|
-6.27 units on a scale
Standard Error 0.35
|
-6.69 units on a scale
Standard Error 0.35
|
-5.21 units on a scale
Standard Error 0.30
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population:randomized participants who received at least 1 dose of SC study medication(either tanezumab or matching placebo).Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Average LBP was assessed on an 11-point NRS captured through an IRT. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16
|
-2.68 units on a scale
Standard Error 0.15
|
-2.98 units on a scale
Standard Error 0.14
|
-3.08 units on a scale
Standard Error 0.14
|
-2.81 units on a scale
Standard Error 0.12
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once daily from baseline up to week 16, and once weekly from week 16 to week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change at Week 2
|
-1.17 units on a scale
Standard Error 0.09
|
-1.54 units on a scale
Standard Error 0.09
|
-1.59 units on a scale
Standard Error 0.09
|
-1.36 units on a scale
Standard Error 0.08
|
—
|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change at Week 4
|
-1.75 units on a scale
Standard Error 0.12
|
-2.24 units on a scale
Standard Error 0.12
|
-2.43 units on a scale
Standard Error 0.12
|
-1.99 units on a scale
Standard Error 0.10
|
—
|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change at Week 8
|
-2.10 units on a scale
Standard Error 0.13
|
-2.64 units on a scale
Standard Error 0.13
|
-2.79 units on a scale
Standard Error 0.13
|
-2.43 units on a scale
Standard Error 0.11
|
—
|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change at Week 12
|
-2.54 units on a scale
Standard Error 0.13
|
-2.92 units on a scale
Standard Error 0.13
|
-3.12 units on a scale
Standard Error 0.13
|
-2.74 units on a scale
Standard Error 0.11
|
—
|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change at Week 24
|
—
|
-2.76 units on a scale
Standard Error 0.16
|
-2.92 units on a scale
Standard Error 0.16
|
-2.64 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change at Week 32
|
—
|
-2.74 units on a scale
Standard Error 0.17
|
-2.75 units on a scale
Standard Error 0.16
|
-2.52 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change at Week 40
|
—
|
-2.64 units on a scale
Standard Error 0.17
|
-2.67 units on a scale
Standard Error 0.17
|
-2.49 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change at Week 48
|
—
|
-2.58 units on a scale
Standard Error 0.17
|
-2.62 units on a scale
Standard Error 0.17
|
-2.43 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change at Week 56
|
—
|
-2.52 units on a scale
Standard Error 0.17
|
-2.62 units on a scale
Standard Error 0.17
|
-2.40 units on a scale
Standard Error 0.15
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). 'Number analyzed' (n)= participants evaluable for this outcome measure (OM) at specified time point.
Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64
Change at Week 64
|
-4.36 units on a scale
Standard Deviation 2.28
|
-4.32 units on a scale
Standard Deviation 2.01
|
-4.04 units on a scale
Standard Deviation 2.15
|
-3.71 units on a scale
Standard Deviation 2.39
|
-4.08 units on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64
Baseline
|
7.16 units on a scale
Standard Deviation 1.15
|
7.23 units on a scale
Standard Deviation 1.09
|
7.25 units on a scale
Standard Deviation 1.08
|
7.18 units on a scale
Standard Deviation 1.13
|
7.17 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Change at Week 24
|
—
|
-5.57 units on a scale
Standard Error 0.41
|
-5.92 units on a scale
Standard Error 0.41
|
-4.59 units on a scale
Standard Error 0.35
|
—
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Change at Week 32
|
—
|
-5.46 units on a scale
Standard Error 0.42
|
-5.71 units on a scale
Standard Error 0.42
|
-4.74 units on a scale
Standard Error 0.35
|
—
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Change at Week 40
|
—
|
-5.12 units on a scale
Standard Error 0.43
|
-5.24 units on a scale
Standard Error 0.44
|
-4.53 units on a scale
Standard Error 0.36
|
—
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Change at Week 48
|
—
|
-4.92 units on a scale
Standard Error 0.43
|
-5.14 units on a scale
Standard Error 0.43
|
-4.44 units on a scale
Standard Error 0.37
|
—
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Change at Week 56
|
—
|
-4.85 units on a scale
Standard Error 0.45
|
-5.23 units on a scale
Standard Error 0.44
|
-4.41 units on a scale
Standard Error 0.36
|
—
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Change at Week 4
|
-3.37 units on a scale
Standard Error 0.29
|
-4.58 units on a scale
Standard Error 0.29
|
-5.32 units on a scale
Standard Error 0.29
|
-3.67 units on a scale
Standard Error 0.25
|
—
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Change at Week 2
|
-2.46 units on a scale
Standard Error 0.26
|
-3.30 units on a scale
Standard Error 0.25
|
-3.84 units on a scale
Standard Error 0.26
|
-2.74 units on a scale
Standard Error 0.21
|
—
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Change at Week 8
|
-3.90 units on a scale
Standard Error 0.31
|
-5.27 units on a scale
Standard Error 0.31
|
-5.85 units on a scale
Standard Error 0.31
|
-4.51 units on a scale
Standard Error 0.27
|
—
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Change at Week 16
|
-4.95 units on a scale
Standard Error 0.36
|
-6.27 units on a scale
Standard Error 0.35
|
-6.69 units on a scale
Standard Error 0.35
|
-5.21 units on a scale
Standard Error 0.30
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 64 and 80Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'number analyzed' = participants evaluable for this outcome measure at specified time points.
The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data
Baseline
|
14.64 units on a scale
Standard Deviation 5.26
|
14.98 units on a scale
Standard Deviation 5.03
|
15.02 units on a scale
Standard Deviation 5.21
|
15.06 units on a scale
Standard Deviation 4.92
|
15.10 units on a scale
Standard Deviation 5.11
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data
Change at Week 64
|
-8.35 units on a scale
Standard Deviation 6.72
|
-8.71 units on a scale
Standard Deviation 5.78
|
-8.72 units on a scale
Standard Deviation 6.32
|
-7.64 units on a scale
Standard Deviation 5.96
|
-8.87 units on a scale
Standard Deviation 5.88
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data
Change at Week 80
|
-8.03 units on a scale
Standard Deviation 7.00
|
-7.27 units on a scale
Standard Deviation 6.79
|
-8.80 units on a scale
Standard Deviation 6.68
|
-7.13 units on a scale
Standard Deviation 5.99
|
-8.35 units on a scale
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 2
|
-0.54 units on a scale
Standard Error 0.04
|
-0.62 units on a scale
Standard Error 0.04
|
-0.67 units on a scale
Standard Error 0.04
|
-0.54 units on a scale
Standard Error 0.03
|
—
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 4
|
-0.64 units on a scale
Standard Error 0.04
|
-0.82 units on a scale
Standard Error 0.04
|
-0.86 units on a scale
Standard Error 0.04
|
-0.66 units on a scale
Standard Error 0.04
|
—
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 8
|
-0.69 units on a scale
Standard Error 0.05
|
-0.82 units on a scale
Standard Error 0.05
|
-0.89 units on a scale
Standard Error 0.05
|
-0.76 units on a scale
Standard Error 0.04
|
—
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 16
|
-0.86 units on a scale
Standard Error 0.05
|
-0.98 units on a scale
Standard Error 0.05
|
-1.02 units on a scale
Standard Error 0.05
|
-0.85 units on a scale
Standard Error 0.04
|
—
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 24
|
—
|
-0.83 units on a scale
Standard Error 0.06
|
-0.82 units on a scale
Standard Error 0.06
|
-0.74 units on a scale
Standard Error 0.05
|
—
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 32
|
—
|
-0.80 units on a scale
Standard Error 0.06
|
-0.79 units on a scale
Standard Error 0.06
|
-0.74 units on a scale
Standard Error 0.05
|
—
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 40
|
—
|
-0.80 units on a scale
Standard Error 0.06
|
-0.75 units on a scale
Standard Error 0.06
|
-0.70 units on a scale
Standard Error 0.05
|
—
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 48
|
—
|
-0.74 units on a scale
Standard Error 0.07
|
-0.72 units on a scale
Standard Error 0.07
|
-0.66 units on a scale
Standard Error 0.06
|
—
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 56
|
—
|
-0.76 units on a scale
Standard Error 0.06
|
-0.74 units on a scale
Standard Error 0.07
|
-0.66 units on a scale
Standard Error 0.06
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'Number analyzed' = participants evaluable for this outcome measure at specified time point.
PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data
Baseline
|
3.47 units on a scale
Standard Deviation 0.65
|
3.49 units on a scale
Standard Deviation 0.60
|
3.47 units on a scale
Standard Deviation 0.61
|
3.53 units on a scale
Standard Deviation 0.63
|
3.50 units on a scale
Standard Deviation 0.63
|
|
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data
Change at Week 64
|
-1.21 units on a scale
Standard Deviation 1.02
|
-1.16 units on a scale
Standard Deviation 0.86
|
-1.03 units on a scale
Standard Deviation 0.98
|
-1.01 units on a scale
Standard Deviation 0.92
|
-1.14 units on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 24 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. Overall Number of Participants analyzed(N)=participants evaluable for this outcome measure (OM).
Average LBP was assessed on an 11-point NRS captured through an IRT. LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.Percentage of participants with cumulative reduction (as percent) (greater than \[\>\] 0%; \>= 10, 20, 30, 40, 50, 60, 70, 80, 90 and equals to \[=\] 100 %) in LBPI from baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Missing data was imputed using mixed BOCF/LOCF.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.Also, intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
Outcome measures
| Measure |
Placebo
n=404 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=406 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=406 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >0%
|
80.8 percentage of participants
|
85.3 percentage of participants
|
87.2 percentage of participants
|
80.8 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >=10%
|
73.6 percentage of participants
|
79.1 percentage of participants
|
82.1 percentage of participants
|
74.5 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >=20%
|
64.8 percentage of participants
|
72.5 percentage of participants
|
73.2 percentage of participants
|
64.8 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >=30%
|
55.7 percentage of participants
|
64.6 percentage of participants
|
65.4 percentage of participants
|
57.9 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >=40%
|
46.8 percentage of participants
|
52.1 percentage of participants
|
56.3 percentage of participants
|
49.9 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >=50%
|
37.2 percentage of participants
|
43.2 percentage of participants
|
46.2 percentage of participants
|
42.8 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >=60%
|
29.3 percentage of participants
|
33.4 percentage of participants
|
36.9 percentage of participants
|
32.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >=70%
|
18.5 percentage of participants
|
21.6 percentage of participants
|
25.1 percentage of participants
|
20.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >=80%
|
10.3 percentage of participants
|
13.3 percentage of participants
|
15.7 percentage of participants
|
13.4 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: >=90%
|
5.4 percentage of participants
|
7.4 percentage of participants
|
6.6 percentage of participants
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: =100%
|
2.7 percentage of participants
|
3.9 percentage of participants
|
2.7 percentage of participants
|
4.1 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >0%
|
—
|
71.9 percentage of participants
|
72.4 percentage of participants
|
66.4 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >=10%
|
—
|
68.5 percentage of participants
|
69.2 percentage of participants
|
63.1 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >=20%
|
—
|
61.8 percentage of participants
|
64.8 percentage of participants
|
58.0 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >=30%
|
—
|
57.6 percentage of participants
|
62.1 percentage of participants
|
53.6 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >=40%
|
—
|
51.5 percentage of participants
|
55.9 percentage of participants
|
47.8 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >=50%
|
—
|
44.1 percentage of participants
|
48.8 percentage of participants
|
41.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >=60%
|
—
|
33.7 percentage of participants
|
37.4 percentage of participants
|
32.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >=70%
|
—
|
24.4 percentage of participants
|
27.6 percentage of participants
|
23.8 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >=80%
|
—
|
16.5 percentage of participants
|
15.3 percentage of participants
|
14.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: >=90%
|
—
|
6.2 percentage of participants
|
7.1 percentage of participants
|
6.6 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: =100%
|
—
|
3.4 percentage of participants
|
5.2 percentage of participants
|
3.8 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=0%
|
—
|
59.9 percentage of participants
|
61.1 percentage of participants
|
58.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=10%
|
—
|
57.6 percentage of participants
|
58.9 percentage of participants
|
55.7 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=20%
|
—
|
53.2 percentage of participants
|
55.7 percentage of participants
|
51.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=30%
|
—
|
50.7 percentage of participants
|
53.9 percentage of participants
|
46.8 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=40%
|
—
|
46.1 percentage of participants
|
50.7 percentage of participants
|
42.1 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=50%
|
—
|
41.6 percentage of participants
|
45.3 percentage of participants
|
38.7 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=60%
|
—
|
34.5 percentage of participants
|
36.0 percentage of participants
|
31.1 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=70%
|
—
|
27.1 percentage of participants
|
27.6 percentage of participants
|
23.3 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=80%
|
—
|
17.2 percentage of participants
|
19.0 percentage of participants
|
15.5 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: >=90%
|
—
|
8.9 percentage of participants
|
10.3 percentage of participants
|
9.3 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: =100%
|
—
|
6.7 percentage of participants
|
7.9 percentage of participants
|
6.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. N=participants evaluable for this OM.
Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with reduction in LBPI of at least (\>=) 30%, 50%, 70% and 90% at weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 compared to baseline were classified as responders to LBPI and are reported here, participants (%) are reported more than once in categories specified.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.Also, intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
Outcome measures
| Measure |
Placebo
n=404 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=406 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=406 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 2: At least 30% reduction
|
20.8 percentage of participants
|
31.3 percentage of participants
|
31.8 percentage of participants
|
28.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 2: At least 50% reduction
|
8.9 percentage of participants
|
13.1 percentage of participants
|
14.8 percentage of participants
|
11.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 2: At least 70% reduction
|
2.7 percentage of participants
|
5.2 percentage of participants
|
5.7 percentage of participants
|
3.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 2: At least 90% reduction
|
1.0 percentage of participants
|
1.0 percentage of participants
|
1.7 percentage of participants
|
0.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 4: At least 30% reduction
|
35.6 percentage of participants
|
47.5 percentage of participants
|
53.2 percentage of participants
|
42.1 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 4: At least 50% reduction
|
19.1 percentage of participants
|
26.1 percentage of participants
|
30.8 percentage of participants
|
23.0 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 4: At least 70% reduction
|
7.4 percentage of participants
|
12.8 percentage of participants
|
17.7 percentage of participants
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 4: At least 90% reduction
|
2.7 percentage of participants
|
2.7 percentage of participants
|
3.7 percentage of participants
|
2.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 8: At least 30% reduction
|
42.6 percentage of participants
|
56.2 percentage of participants
|
59.4 percentage of participants
|
51.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 8: At least 50% reduction
|
24.0 percentage of participants
|
35.7 percentage of participants
|
40.1 percentage of participants
|
31.9 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 8: At least 70% reduction
|
10.9 percentage of participants
|
15.3 percentage of participants
|
21.7 percentage of participants
|
14.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 8: At least 90% reduction
|
4.0 percentage of participants
|
4.4 percentage of participants
|
4.4 percentage of participants
|
3.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 12: At least 30% reduction
|
53.5 percentage of participants
|
61.3 percentage of participants
|
66.5 percentage of participants
|
56.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 12: At least 50% reduction
|
34.7 percentage of participants
|
41.9 percentage of participants
|
47.3 percentage of participants
|
38.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 12: At least 70% reduction
|
14.9 percentage of participants
|
19.7 percentage of participants
|
26.4 percentage of participants
|
19.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 12: At least 90% reduction
|
5.0 percentage of participants
|
7.6 percentage of participants
|
7.9 percentage of participants
|
6.1 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: At least 30% reduction
|
55.9 percentage of participants
|
64.8 percentage of participants
|
65.5 percentage of participants
|
57.9 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: At least 50% reduction
|
37.4 percentage of participants
|
43.3 percentage of participants
|
46.3 percentage of participants
|
42.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: At least 70% reduction
|
18.6 percentage of participants
|
21.7 percentage of participants
|
25.1 percentage of participants
|
20.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: At least 90% reduction
|
5.4 percentage of participants
|
7.4 percentage of participants
|
6.7 percentage of participants
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: At least 30% reduction
|
—
|
57.6 percentage of participants
|
62.1 percentage of participants
|
53.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: At least 50% reduction
|
—
|
44.1 percentage of participants
|
48.8 percentage of participants
|
41.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: At least 70% reduction
|
—
|
24.4 percentage of participants
|
27.6 percentage of participants
|
23.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: At least 90% reduction
|
—
|
6.2 percentage of participants
|
7.1 percentage of participants
|
6.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 32: At least 30% reduction
|
—
|
56.7 percentage of participants
|
57.6 percentage of participants
|
50.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 32: At least 50% reduction
|
—
|
44.6 percentage of participants
|
46.3 percentage of participants
|
39.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 32: At least 70% reduction
|
—
|
27.1 percentage of participants
|
25.6 percentage of participants
|
22.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 32: At least 90% reduction
|
—
|
7.6 percentage of participants
|
9.6 percentage of participants
|
7.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 40: At least 30% reduction
|
—
|
53.0 percentage of participants
|
53.9 percentage of participants
|
49.4 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 40: At least 50% reduction
|
—
|
43.1 percentage of participants
|
44.8 percentage of participants
|
39.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 40: At least 70% reduction
|
—
|
26.4 percentage of participants
|
28.1 percentage of participants
|
24.1 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 40: At least 90% reduction
|
—
|
9.6 percentage of participants
|
11.3 percentage of participants
|
7.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 48: At least 30% reduction
|
—
|
52.2 percentage of participants
|
53.0 percentage of participants
|
48.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 48: At least 50% reduction
|
—
|
43.1 percentage of participants
|
44.6 percentage of participants
|
38.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 48: At least 70% reduction
|
—
|
27.1 percentage of participants
|
26.6 percentage of participants
|
23.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 48: At least 90% reduction
|
—
|
9.4 percentage of participants
|
11.1 percentage of participants
|
8.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: At least 30% reduction
|
—
|
50.7 percentage of participants
|
53.9 percentage of participants
|
46.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: At least 50% reduction
|
—
|
41.6 percentage of participants
|
45.3 percentage of participants
|
38.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: At least 70% reduction
|
—
|
27.1 percentage of participants
|
27.6 percentage of participants
|
23.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: At least 90% reduction
|
—
|
8.9 percentage of participants
|
10.3 percentage of participants
|
9.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. N =participants evaluable for this OM.
RMDQ: health status measure index of how well participants with LBP are able to function with regard to daily activities. Measures pain and function using 24 items describing limitations to everyday life. Total score of RMDQ is total number of items checked ranging from 0=no disability to 24=maximum disability, higher scores=greater disability. Percentage of participants with reduction in LBPI of at least (\>=) 30, 50, 70 and 90% at specified weeks compared to baseline were classified as responders to LBPI and are reported here. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms. Also, intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=405 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 2: At least 30% reduction
|
24.1 percentage of participants
|
32.3 percentage of participants
|
38.3 percentage of participants
|
29.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 2: At least 50% reduction
|
13.5 percentage of participants
|
20.0 percentage of participants
|
21.4 percentage of participants
|
16.9 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 2: At least 70% reduction
|
5.7 percentage of participants
|
10.6 percentage of participants
|
10.3 percentage of participants
|
6.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 2: At least 90% reduction
|
1.7 percentage of participants
|
4.2 percentage of participants
|
5.4 percentage of participants
|
2.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 4: At least 30% reduction
|
34.5 percentage of participants
|
46.2 percentage of participants
|
50.4 percentage of participants
|
39.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 4: At least 50% reduction
|
19.2 percentage of participants
|
30.9 percentage of participants
|
34.2 percentage of participants
|
25.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 4: At least 70% reduction
|
10.1 percentage of participants
|
17.5 percentage of participants
|
21.1 percentage of participants
|
10.9 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 4: At least 90% reduction
|
4.2 percentage of participants
|
7.9 percentage of participants
|
9.6 percentage of participants
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 8: At least 30% reduction
|
41.1 percentage of participants
|
52.8 percentage of participants
|
56.8 percentage of participants
|
48.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 8: At least 50% reduction
|
26.4 percentage of participants
|
36.8 percentage of participants
|
40.8 percentage of participants
|
33.4 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 8: At least 70% reduction
|
12.8 percentage of participants
|
23.2 percentage of participants
|
24.8 percentage of participants
|
16.4 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 8: At least 90% reduction
|
4.9 percentage of participants
|
12.1 percentage of participants
|
13.8 percentage of participants
|
6.4 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: At least 30% reduction
|
48.5 percentage of participants
|
58.3 percentage of participants
|
62.2 percentage of participants
|
52.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: At least 50% reduction
|
34.7 percentage of participants
|
46.7 percentage of participants
|
48.2 percentage of participants
|
38.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: At least 70% reduction
|
20.7 percentage of participants
|
32.1 percentage of participants
|
34.6 percentage of participants
|
22.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 16: At least 90% reduction
|
9.1 percentage of participants
|
17.0 percentage of participants
|
15.5 percentage of participants
|
8.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: At least 30% reduction
|
—
|
50.1 percentage of participants
|
53.3 percentage of participants
|
44.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: At least 50% reduction
|
—
|
42.5 percentage of participants
|
45.0 percentage of participants
|
34.0 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: At least 70% reduction
|
—
|
29.4 percentage of participants
|
31.7 percentage of participants
|
20.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 24: At least 90% reduction
|
—
|
16.5 percentage of participants
|
18.4 percentage of participants
|
8.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 32: At least 30% reduction
|
—
|
48.6 percentage of participants
|
49.4 percentage of participants
|
43.0 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 32: At least 50% reduction
|
—
|
42.0 percentage of participants
|
44.7 percentage of participants
|
35.9 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 32: At least 70% reduction
|
—
|
29.1 percentage of participants
|
31.9 percentage of participants
|
22.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 32: At least 90% reduction
|
—
|
17.8 percentage of participants
|
17.9 percentage of participants
|
11.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 40: At least 30% reduction
|
—
|
44.9 percentage of participants
|
48.2 percentage of participants
|
41.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 40: At least 50% reduction
|
—
|
38.5 percentage of participants
|
40.8 percentage of participants
|
34.4 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 40: At least 70% reduction
|
—
|
29.9 percentage of participants
|
29.5 percentage of participants
|
23.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 40: At least 90% reduction
|
—
|
17.3 percentage of participants
|
17.2 percentage of participants
|
11.4 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 48: At least 30% reduction
|
—
|
43.0 percentage of participants
|
45.2 percentage of participants
|
40.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 48: At least 50% reduction
|
—
|
38.0 percentage of participants
|
37.8 percentage of participants
|
33.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 48: At least 70% reduction
|
—
|
28.4 percentage of participants
|
29.5 percentage of participants
|
22.0 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 48: At least 90% reduction
|
—
|
16.3 percentage of participants
|
17.7 percentage of participants
|
11.4 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: At least 30% reduction
|
—
|
41.2 percentage of participants
|
46.4 percentage of participants
|
41.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: At least 50% reduction
|
—
|
36.5 percentage of participants
|
38.8 percentage of participants
|
32.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: At least 70% reduction
|
—
|
27.9 percentage of participants
|
28.5 percentage of participants
|
22.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Week 56: At least 90% reduction
|
—
|
17.8 percentage of participants
|
18.7 percentage of participants
|
11.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 24 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this OM,as those who met criteria to continue,switched to active treatment with tanezumab(tan) after W16.N=participants evaluable for this OM.Intent of study was to compare tan V placebo for data up to \& including W16 \& comparisons of tan Vs tramadol for data up to \& including W56.
The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. Percentage of participants with cumulative reduction (as percent) (\>0 %; \>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 %, 90% and =100 %) in RMDQ from Baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=405 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=0%
|
71.2 percentage of participants
|
76.8 percentage of participants
|
83.5 percentage of participants
|
71.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=10%
|
68.2 percentage of participants
|
72.6 percentage of participants
|
78.4 percentage of participants
|
66.3 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=20%
|
60.6 percentage of participants
|
65.4 percentage of participants
|
70.3 percentage of participants
|
59.3 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=30%
|
48.5 percentage of participants
|
58.3 percentage of participants
|
62.2 percentage of participants
|
52.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=40%
|
42.1 percentage of participants
|
53.1 percentage of participants
|
53.3 percentage of participants
|
44.3 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=50%
|
34.7 percentage of participants
|
46.7 percentage of participants
|
48.2 percentage of participants
|
38.7 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=60%
|
26.1 percentage of participants
|
38.0 percentage of participants
|
41.0 percentage of participants
|
30.9 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=70%
|
20.7 percentage of participants
|
32.1 percentage of participants
|
34.6 percentage of participants
|
22.3 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=80%
|
14.8 percentage of participants
|
23.2 percentage of participants
|
26.5 percentage of participants
|
15.5 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: >=90%
|
9.1 percentage of participants
|
17.0 percentage of participants
|
15.5 percentage of participants
|
8.6 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 16: =100%
|
6.4 percentage of participants
|
13.3 percentage of participants
|
9.3 percentage of participants
|
4.8 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=0%
|
—
|
60.5 percentage of participants
|
64.6 percentage of participants
|
57.7 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=10%
|
—
|
58.3 percentage of participants
|
61.9 percentage of participants
|
55.7 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=20%
|
—
|
54.6 percentage of participants
|
56.5 percentage of participants
|
51.1 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=30%
|
—
|
50.1 percentage of participants
|
53.3 percentage of participants
|
44.8 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=40%
|
—
|
46.7 percentage of participants
|
48.2 percentage of participants
|
39.5 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=50%
|
—
|
42.5 percentage of participants
|
45.0 percentage of participants
|
34.0 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=60%
|
—
|
35.8 percentage of participants
|
38.6 percentage of participants
|
26.1 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=70%
|
—
|
29.4 percentage of participants
|
31.7 percentage of participants
|
20.7 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=80%
|
—
|
22.2 percentage of participants
|
25.3 percentage of participants
|
14.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: >=90%
|
—
|
16.5 percentage of participants
|
18.4 percentage of participants
|
8.3 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 24: =100%
|
—
|
11.6 percentage of participants
|
11.5 percentage of participants
|
5.6 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >0%
|
—
|
51.6 percentage of participants
|
56.5 percentage of participants
|
52.6 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >=10%
|
—
|
50.1 percentage of participants
|
54.8 percentage of participants
|
49.9 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >=20%
|
—
|
46.2 percentage of participants
|
50.9 percentage of participants
|
46.0 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >=30%
|
—
|
41.2 percentage of participants
|
46.4 percentage of participants
|
41.5 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >=40%
|
—
|
38.0 percentage of participants
|
42.5 percentage of participants
|
36.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >=50%
|
—
|
36.5 percentage of participants
|
38.8 percentage of participants
|
32.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >=60%
|
—
|
31.9 percentage of participants
|
33.2 percentage of participants
|
27.1 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >=70%
|
—
|
27.9 percentage of participants
|
28.5 percentage of participants
|
22.3 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >=80%
|
—
|
22.7 percentage of participants
|
24.3 percentage of participants
|
17.2 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: >=90%
|
—
|
17.8 percentage of participants
|
18.7 percentage of participants
|
11.7 percentage of participants
|
—
|
|
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Week 56: =100%
|
—
|
13.8 percentage of participants
|
14.0 percentage of participants
|
7.4 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Worst Pain item of the BPI-sf scale (11 point NRS scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain at its worst, during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 2
|
-1.17 units on a scale
Standard Error 0.10
|
-1.66 units on a scale
Standard Error 0.10
|
-1.76 units on a scale
Standard Error 0.10
|
-1.40 units on a scale
Standard Error 0.09
|
—
|
|
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 4
|
-1.73 units on a scale
Standard Error 0.12
|
-2.30 units on a scale
Standard Error 0.12
|
-2.50 units on a scale
Standard Error 0.12
|
-1.98 units on a scale
Standard Error 0.11
|
—
|
|
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 8
|
-2.11 units on a scale
Standard Error 0.13
|
-2.57 units on a scale
Standard Error 0.13
|
-2.86 units on a scale
Standard Error 0.13
|
-2.37 units on a scale
Standard Error 0.11
|
—
|
|
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 16
|
-2.67 units on a scale
Standard Error 0.15
|
-3.18 units on a scale
Standard Error 0.14
|
-3.21 units on a scale
Standard Error 0.14
|
-2.90 units on a scale
Standard Error 0.12
|
—
|
|
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 24
|
—
|
-2.81 units on a scale
Standard Error 0.17
|
-3.01 units on a scale
Standard Error 0.17
|
-2.66 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 32
|
—
|
-2.88 units on a scale
Standard Error 0.17
|
-2.95 units on a scale
Standard Error 0.17
|
-2.63 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 40
|
—
|
-2.70 units on a scale
Standard Error 0.18
|
-2.78 units on a scale
Standard Error 0.18
|
-2.51 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 48
|
—
|
-2.66 units on a scale
Standard Error 0.19
|
-2.73 units on a scale
Standard Error 0.18
|
-2.44 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change at Week 56
|
—
|
-2.66 units on a scale
Standard Error 0.19
|
-2.74 units on a scale
Standard Error 0.18
|
-2.45 units on a scale
Standard Error 0.15
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = participants evaluable for this OM at specified time points.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Worst Pain item of the BPI-sf scale (11 point NRS scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain at its worst, during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data
Baseline
|
7.93 units on a scale
Standard Deviation 1.18
|
7.91 units on a scale
Standard Deviation 1.09
|
7.95 units on a scale
Standard Deviation 1.11
|
7.92 units on a scale
Standard Deviation 1.19
|
7.92 units on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data
Change at Week 64
|
-3.90 units on a scale
Standard Deviation 2.69
|
-4.28 units on a scale
Standard Deviation 2.37
|
-4.01 units on a scale
Standard Deviation 2.68
|
-3.61 units on a scale
Standard Deviation 2.52
|
-4.23 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Average Pain item of the BPI-sf scale (11 point NRS scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 2
|
-0.93 units on a scale
Standard Error 0.10
|
-1.40 units on a scale
Standard Error 0.10
|
-1.47 units on a scale
Standard Error 0.10
|
-1.20 units on a scale
Standard Error 0.08
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 4
|
-1.52 units on a scale
Standard Error 0.12
|
-2.04 units on a scale
Standard Error 0.12
|
-2.22 units on a scale
Standard Error 0.12
|
-1.76 units on a scale
Standard Error 0.10
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 8
|
-1.90 units on a scale
Standard Error 0.12
|
-2.36 units on a scale
Standard Error 0.12
|
-2.60 units on a scale
Standard Error 0.12
|
-2.20 units on a scale
Standard Error 0.10
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 16
|
-2.47 units on a scale
Standard Error 0.14
|
-2.84 units on a scale
Standard Error 0.14
|
-2.93 units on a scale
Standard Error 0.14
|
-2.64 units on a scale
Standard Error 0.12
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 24
|
—
|
-2.58 units on a scale
Standard Error 0.16
|
-2.72 units on a scale
Standard Error 0.16
|
-2.45 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 32
|
—
|
-2.61 units on a scale
Standard Error 0.16
|
-2.67 units on a scale
Standard Error 0.16
|
-2.43 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 40
|
—
|
-2.46 units on a scale
Standard Error 0.17
|
-2.53 units on a scale
Standard Error 0.17
|
-2.32 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 48
|
—
|
-2.40 units on a scale
Standard Error 0.17
|
-2.44 units on a scale
Standard Error 0.17
|
-2.29 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 56
|
—
|
-2.32 units on a scale
Standard Error 0.17
|
-2.51 units on a scale
Standard Error 0.17
|
-2.29 units on a scale
Standard Error 0.14
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'number analyzed' = participants evaluable for this OM at specified time point.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Average Pain item of the BPI-sf scale (11 point NRS scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data
Baseline
|
6.87 units on a scale
Standard Deviation 1.20
|
7.02 units on a scale
Standard Deviation 1.15
|
7.00 units on a scale
Standard Deviation 1.18
|
6.88 units on a scale
Standard Deviation 1.21
|
6.97 units on a scale
Standard Deviation 1.21
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data
Change at Week 64
|
-3.75 units on a scale
Standard Deviation 2.37
|
-4.09 units on a scale
Standard Deviation 1.82
|
-3.84 units on a scale
Standard Deviation 2.23
|
-3.39 units on a scale
Standard Deviation 2.38
|
-4.04 units on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 2
|
-1.40 units on a scale
Standard Error 0.11
|
-1.88 units on a scale
Standard Error 0.11
|
-1.97 units on a scale
Standard Error 0.11
|
-1.57 units on a scale
Standard Error 0.10
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 4
|
-1.90 units on a scale
Standard Error 0.13
|
-2.50 units on a scale
Standard Error 0.13
|
-2.68 units on a scale
Standard Error 0.13
|
-2.14 units on a scale
Standard Error 0.11
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 8
|
-2.26 units on a scale
Standard Error 0.13
|
-2.70 units on a scale
Standard Error 0.13
|
-2.83 units on a scale
Standard Error 0.13
|
-2.44 units on a scale
Standard Error 0.11
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 16
|
-2.65 units on a scale
Standard Error 0.14
|
-3.06 units on a scale
Standard Error 0.14
|
-3.23 units on a scale
Standard Error 0.14
|
-2.80 units on a scale
Standard Error 0.12
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 24
|
—
|
-2.67 units on a scale
Standard Error 0.17
|
-2.75 units on a scale
Standard Error 0.16
|
-2.44 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 32
|
—
|
-2.64 units on a scale
Standard Error 0.16
|
-2.64 units on a scale
Standard Error 0.16
|
-2.37 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 40
|
—
|
-2.44 units on a scale
Standard Error 0.17
|
-2.48 units on a scale
Standard Error 0.17
|
-2.24 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 48
|
—
|
-2.37 units on a scale
Standard Error 0.17
|
-2.37 units on a scale
Standard Error 0.17
|
-2.18 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 56
|
—
|
-2.32 units on a scale
Standard Error 0.17
|
-2.44 units on a scale
Standard Error 0.17
|
-2.21 units on a scale
Standard Error 0.15
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = participants evaluable for this OM at specified time point.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data
Change at Week 64
|
-3.87 units on a scale
Standard Deviation 2.63
|
-4.21 units on a scale
Standard Deviation 1.98
|
-4.00 units on a scale
Standard Deviation 2.44
|
-3.60 units on a scale
Standard Deviation 2.30
|
-3.98 units on a scale
Standard Deviation 2.10
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data
Baseline
|
5.85 units on a scale
Standard Deviation 1.90
|
6.20 units on a scale
Standard Deviation 1.88
|
6.28 units on a scale
Standard Deviation 1.81
|
6.16 units on a scale
Standard Deviation 1.93
|
6.21 units on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 2
|
-1.46 units on a scale
Standard Error 0.12
|
-1.84 units on a scale
Standard Error 0.12
|
-1.91 units on a scale
Standard Error 0.12
|
-1.53 units on a scale
Standard Error 0.10
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 4
|
-1.92 units on a scale
Standard Error 0.13
|
-2.45 units on a scale
Standard Error 0.13
|
-2.71 units on a scale
Standard Error 0.13
|
-2.14 units on a scale
Standard Error 0.12
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 8
|
-2.37 units on a scale
Standard Error 0.14
|
-2.68 units on a scale
Standard Error 0.14
|
-2.86 units on a scale
Standard Error 0.14
|
-2.54 units on a scale
Standard Error 0.12
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 16
|
-2.70 units on a scale
Standard Error 0.15
|
-3.20 units on a scale
Standard Error 0.15
|
-3.35 units on a scale
Standard Error 0.15
|
-2.89 units on a scale
Standard Error 0.13
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 24
|
—
|
-2.78 units on a scale
Standard Error 0.17
|
-2.87 units on a scale
Standard Error 0.17
|
-2.60 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 32
|
—
|
-2.74 units on a scale
Standard Error 0.18
|
-2.76 units on a scale
Standard Error 0.17
|
-2.52 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 40
|
—
|
-2.54 units on a scale
Standard Error 0.18
|
-2.58 units on a scale
Standard Error 0.18
|
-2.40 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 48
|
—
|
-2.47 units on a scale
Standard Error 0.18
|
-2.47 units on a scale
Standard Error 0.18
|
-2.33 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 56
|
—
|
-2.44 units on a scale
Standard Error 0.18
|
-2.53 units on a scale
Standard Error 0.18
|
-2.39 units on a scale
Standard Error 0.15
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = participants evaluable for this OM at specified time point.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data
Change at Week 64
|
-3.87 units on a scale
Standard Deviation 2.79
|
-4.46 units on a scale
Standard Deviation 2.19
|
-4.03 units on a scale
Standard Deviation 2.74
|
-3.72 units on a scale
Standard Deviation 2.57
|
-4.16 units on a scale
Standard Deviation 2.33
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data
Baseline
|
6.40 units on a scale
Standard Deviation 1.81
|
6.69 units on a scale
Standard Deviation 1.75
|
6.69 units on a scale
Standard Deviation 1.70
|
6.66 units on a scale
Standard Deviation 1.82
|
6.67 units on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 2
|
-1.28 units on a scale
Standard Error 0.12
|
-1.72 units on a scale
Standard Error 0.12
|
-1.89 units on a scale
Standard Error 0.12
|
-1.54 units on a scale
Standard Error 0.10
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 4
|
-1.81 units on a scale
Standard Error 0.13
|
-2.38 units on a scale
Standard Error 0.13
|
-2.55 units on a scale
Standard Error 0.13
|
-2.03 units on a scale
Standard Error 0.12
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 8
|
-2.17 units on a scale
Standard Error 0.14
|
-2.60 units on a scale
Standard Error 0.13
|
-2.73 units on a scale
Standard Error 0.13
|
-2.30 units on a scale
Standard Error 0.11
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 16
|
-2.55 units on a scale
Standard Error 0.15
|
-2.90 units on a scale
Standard Error 0.15
|
-3.15 units on a scale
Standard Error 0.15
|
-2.68 units on a scale
Standard Error 0.13
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 24
|
—
|
-2.54 units on a scale
Standard Error 0.17
|
-2.73 units on a scale
Standard Error 0.17
|
-2.30 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 32
|
—
|
-2.50 units on a scale
Standard Error 0.17
|
-2.59 units on a scale
Standard Error 0.17
|
-2.24 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 40
|
—
|
-2.31 units on a scale
Standard Error 0.17
|
-2.46 units on a scale
Standard Error 0.17
|
-2.09 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 48
|
—
|
-2.24 units on a scale
Standard Error 0.17
|
-2.34 units on a scale
Standard Error 0.17
|
-2.04 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 56
|
—
|
-2.24 units on a scale
Standard Error 0.17
|
-2.45 units on a scale
Standard Error 0.17
|
-2.07 units on a scale
Standard Error 0.14
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = participants evaluable for this OM at specified time point.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data
Change at Week 64
|
-3.78 units on a scale
Standard Deviation 2.91
|
-4.14 units on a scale
Standard Deviation 2.37
|
-3.65 units on a scale
Standard Deviation 2.79
|
-3.61 units on a scale
Standard Deviation 2.65
|
-3.78 units on a scale
Standard Deviation 2.37
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data
Baseline
|
5.66 units on a scale
Standard Deviation 2.28
|
6.07 units on a scale
Standard Deviation 2.14
|
5.95 units on a scale
Standard Deviation 2.22
|
6.01 units on a scale
Standard Deviation 2.24
|
6.04 units on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 2
|
-1.58 units on a scale
Standard Error 0.14
|
-2.09 units on a scale
Standard Error 0.13
|
-2.15 units on a scale
Standard Error 0.14
|
-1.80 units on a scale
Standard Error 0.11
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 4
|
-2.13 units on a scale
Standard Error 0.15
|
-2.79 units on a scale
Standard Error 0.15
|
-2.98 units on a scale
Standard Error 0.15
|
-2.34 units on a scale
Standard Error 0.13
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 8
|
-2.42 units on a scale
Standard Error 0.15
|
-2.94 units on a scale
Standard Error 0.15
|
-3.13 units on a scale
Standard Error 0.15
|
-2.70 units on a scale
Standard Error 0.13
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 16
|
-2.92 units on a scale
Standard Error 0.16
|
-3.38 units on a scale
Standard Error 0.16
|
-3.44 units on a scale
Standard Error 0.16
|
-3.00 units on a scale
Standard Error 0.14
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 24
|
—
|
-2.89 units on a scale
Standard Error 0.18
|
-3.09 units on a scale
Standard Error 0.18
|
-2.59 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 32
|
—
|
-2.88 units on a scale
Standard Error 0.18
|
-2.94 units on a scale
Standard Error 0.18
|
-2.54 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 40
|
—
|
-2.64 units on a scale
Standard Error 0.18
|
-2.81 units on a scale
Standard Error 0.19
|
-2.41 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 48
|
—
|
-2.61 units on a scale
Standard Error 0.19
|
-2.73 units on a scale
Standard Error 0.19
|
-2.34 units on a scale
Standard Error 0.16
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 56
|
—
|
-2.57 units on a scale
Standard Error 0.18
|
-2.74 units on a scale
Standard Error 0.18
|
-2.37 units on a scale
Standard Error 0.16
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = participants evaluable for this OM at specified time point.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data
Baseline
|
6.45 units on a scale
Standard Deviation 2.49
|
6.73 units on a scale
Standard Deviation 2.37
|
6.88 units on a scale
Standard Deviation 2.31
|
6.67 units on a scale
Standard Deviation 2.39
|
6.82 units on a scale
Standard Deviation 2.38
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data
Change at Week 64
|
-4.29 units on a scale
Standard Deviation 3.17
|
-4.54 units on a scale
Standard Deviation 2.80
|
-4.19 units on a scale
Standard Deviation 2.95
|
-4.05 units on a scale
Standard Deviation 2.70
|
-4.11 units on a scale
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 2
|
-1.30 units on a scale
Standard Error 0.12
|
-1.86 units on a scale
Standard Error 0.12
|
-2.01 units on a scale
Standard Error 0.12
|
-1.53 units on a scale
Standard Error 0.10
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 4
|
-1.92 units on a scale
Standard Error 0.14
|
-2.43 units on a scale
Standard Error 0.14
|
-2.81 units on a scale
Standard Error 0.14
|
-2.14 units on a scale
Standard Error 0.12
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 8
|
-2.32 units on a scale
Standard Error 0.14
|
-2.70 units on a scale
Standard Error 0.14
|
-2.96 units on a scale
Standard Error 0.14
|
-2.51 units on a scale
Standard Error 0.12
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 16
|
-2.64 units on a scale
Standard Error 0.15
|
-3.15 units on a scale
Standard Error 0.15
|
-3.33 units on a scale
Standard Error 0.16
|
-2.87 units on a scale
Standard Error 0.13
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 24
|
—
|
-2.78 units on a scale
Standard Error 0.17
|
-2.89 units on a scale
Standard Error 0.17
|
-2.53 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 32
|
—
|
-2.72 units on a scale
Standard Error 0.18
|
-2.75 units on a scale
Standard Error 0.18
|
-2.52 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 40
|
—
|
-2.57 units on a scale
Standard Error 0.18
|
-2.60 units on a scale
Standard Error 0.18
|
-2.37 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 48
|
—
|
-2.48 units on a scale
Standard Error 0.18
|
-2.49 units on a scale
Standard Error 0.18
|
-2.33 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Change at Week 56
|
—
|
-2.46 units on a scale
Standard Error 0.18
|
-2.58 units on a scale
Standard Error 0.18
|
-2.33 units on a scale
Standard Error 0.16
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = participants evaluable for this OM at specified time point.
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data
Baseline
|
6.31 units on a scale
Standard Deviation 2.12
|
6.62 units on a scale
Standard Deviation 2.03
|
6.65 units on a scale
Standard Deviation 1.91
|
6.65 units on a scale
Standard Deviation 1.90
|
6.56 units on a scale
Standard Deviation 2.07
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data
Change at Week 64
|
-3.95 units on a scale
Standard Deviation 2.99
|
-4.60 units on a scale
Standard Deviation 2.46
|
-4.15 units on a scale
Standard Deviation 2.86
|
-3.80 units on a scale
Standard Deviation 2.71
|
-4.08 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. N =participants evaluable for this OM.
Chronic Low Back Pain Responder Index analysis is a composite endpoint of average low back pain intensity (aLBPI) score, PGA of Low Back Pain, and RMDQ total score. Participants were successful responders if they had: \>=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of \>=30 percent in PGA of low back pain from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms. Also, intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
Outcome measures
| Measure |
Placebo
n=404 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=404 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=406 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Week 48
|
—
|
148 Participants
|
140 Participants
|
197 Participants
|
—
|
|
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Week 2
|
32 Participants
|
62 Participants
|
76 Participants
|
74 Participants
|
—
|
|
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Week 4
|
67 Participants
|
115 Participants
|
130 Participants
|
134 Participants
|
—
|
|
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Week 8
|
86 Participants
|
131 Participants
|
151 Participants
|
178 Participants
|
—
|
|
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Week 16
|
136 Participants
|
168 Participants
|
179 Participants
|
211 Participants
|
—
|
|
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Week 24
|
—
|
166 Participants
|
158 Participants
|
207 Participants
|
—
|
|
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Week 32
|
—
|
158 Participants
|
160 Participants
|
204 Participants
|
—
|
|
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Week 40
|
—
|
158 Participants
|
149 Participants
|
202 Participants
|
—
|
|
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Week 56
|
—
|
140 Participants
|
144 Participants
|
192 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56Population: ITT population.Data were not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tan after W16. N =participants evaluable for this OM. intent of study was to compare tan Vs placebo for data up to \& including W16 \& comparisons of tan Vs tramadol for data up to \& including W56.
PGA of LBP assessed by asking question to participants:Considering all ways your low back pain affects you,how are you doing today? They responded on 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic \& no limitation of normal activities);2=good (mild symptoms and no limitation of normal activities);3=fair (moderate symptoms and limitation of some normal activities);4=poor (severe symptoms \& inability to carry out most normal activities); \& 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. % of participants with improvement of at least 2 points from baseline in PGA of LBP were reported. Missing data was imputed using BOCF/LOCF. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=405 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Week 2
|
9.4 percentage of participants
|
11.1 percentage of participants
|
14.7 percentage of participants
|
10.1 percentage of participants
|
—
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Week 4
|
13.8 percentage of participants
|
20.5 percentage of participants
|
21.4 percentage of participants
|
15.0 percentage of participants
|
—
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Week 8
|
15.3 percentage of participants
|
20.2 percentage of participants
|
24.1 percentage of participants
|
18.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Week 16
|
22.7 percentage of participants
|
27.4 percentage of participants
|
30.0 percentage of participants
|
22.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Week 24
|
—
|
25.9 percentage of participants
|
25.1 percentage of participants
|
21.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Week 32
|
—
|
25.2 percentage of participants
|
23.1 percentage of participants
|
20.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Week 40
|
—
|
25.9 percentage of participants
|
22.9 percentage of participants
|
20.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Week 48
|
—
|
23.2 percentage of participants
|
22.4 percentage of participants
|
20.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Week 56
|
—
|
24.2 percentage of participants
|
21.1 percentage of participants
|
20.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, 40 and 56Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants evaluable for this OM for specified categories.
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Individual dimension scores ranged from 1.0 (least impairment of health state) to 5.0 (most impairment of health state). Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Mobility
|
2.5 units on a scale
Standard Deviation 0.84
|
2.6 units on a scale
Standard Deviation 0.88
|
2.5 units on a scale
Standard Deviation 0.83
|
2.6 units on a scale
Standard Deviation 0.82
|
2.6 units on a scale
Standard Deviation 0.86
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Self-care
|
2.0 units on a scale
Standard Deviation 0.95
|
2.1 units on a scale
Standard Deviation 0.97
|
2.0 units on a scale
Standard Deviation 0.95
|
2.0 units on a scale
Standard Deviation 0.92
|
2.0 units on a scale
Standard Deviation 0.95
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Usual activities
|
2.8 units on a scale
Standard Deviation 0.90
|
2.8 units on a scale
Standard Deviation 0.83
|
2.8 units on a scale
Standard Deviation 0.82
|
2.8 units on a scale
Standard Deviation 0.80
|
2.8 units on a scale
Standard Deviation 0.84
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Pain/Discomfort
|
3.3 units on a scale
Standard Deviation 0.73
|
3.4 units on a scale
Standard Deviation 0.71
|
3.4 units on a scale
Standard Deviation 0.68
|
3.3 units on a scale
Standard Deviation 0.69
|
3.3 units on a scale
Standard Deviation 0.70
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Baseline: Anxiety/Depression
|
1.8 units on a scale
Standard Deviation 0.99
|
1.9 units on a scale
Standard Deviation 1.03
|
1.9 units on a scale
Standard Deviation 1.01
|
1.9 units on a scale
Standard Deviation 0.98
|
1.9 units on a scale
Standard Deviation 1.00
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Mobility
|
1.9 units on a scale
Standard Deviation 0.78
|
2.0 units on a scale
Standard Deviation 0.90
|
1.8 units on a scale
Standard Deviation 0.85
|
1.8 units on a scale
Standard Deviation 0.81
|
1.9 units on a scale
Standard Deviation 0.87
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Self-care
|
1.5 units on a scale
Standard Deviation 0.71
|
1.7 units on a scale
Standard Deviation 0.79
|
1.4 units on a scale
Standard Deviation 0.66
|
1.4 units on a scale
Standard Deviation 0.65
|
1.5 units on a scale
Standard Deviation 0.73
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Usual activities
|
2.2 units on a scale
Standard Deviation 0.81
|
2.2 units on a scale
Standard Deviation 0.89
|
2.0 units on a scale
Standard Deviation 0.85
|
2.0 units on a scale
Standard Deviation 0.82
|
2.1 units on a scale
Standard Deviation 0.91
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 40: Self-care
|
1.2 units on a scale
Standard Deviation 0.62
|
1.3 units on a scale
Standard Deviation 0.53
|
1.2 units on a scale
Standard Deviation 0.46
|
1.2 units on a scale
Standard Deviation 0.45
|
1.3 units on a scale
Standard Deviation 0.62
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Pain/Discomfort
|
2.7 units on a scale
Standard Deviation 0.82
|
2.6 units on a scale
Standard Deviation 0.84
|
2.5 units on a scale
Standard Deviation 0.80
|
2.4 units on a scale
Standard Deviation 0.80
|
2.5 units on a scale
Standard Deviation 0.79
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 8: Anxiety/Depression
|
1.5 units on a scale
Standard Deviation 0.81
|
1.6 units on a scale
Standard Deviation 0.92
|
1.5 units on a scale
Standard Deviation 0.83
|
1.5 units on a scale
Standard Deviation 0.78
|
1.6 units on a scale
Standard Deviation 0.84
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Mobility
|
1.7 units on a scale
Standard Deviation 0.82
|
1.8 units on a scale
Standard Deviation 0.85
|
1.7 units on a scale
Standard Deviation 0.78
|
1.6 units on a scale
Standard Deviation 0.75
|
1.8 units on a scale
Standard Deviation 0.79
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Self-care
|
1.4 units on a scale
Standard Deviation 0.64
|
1.5 units on a scale
Standard Deviation 0.72
|
1.3 units on a scale
Standard Deviation 0.62
|
1.3 units on a scale
Standard Deviation 0.61
|
1.5 units on a scale
Standard Deviation 0.69
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Usual activities
|
1.9 units on a scale
Standard Deviation 0.81
|
2.0 units on a scale
Standard Deviation 0.85
|
1.8 units on a scale
Standard Deviation 0.84
|
1.8 units on a scale
Standard Deviation 0.80
|
1.9 units on a scale
Standard Deviation 0.82
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Pain/Discomfort
|
2.3 units on a scale
Standard Deviation 0.90
|
2.4 units on a scale
Standard Deviation 0.86
|
2.2 units on a scale
Standard Deviation 0.83
|
2.2 units on a scale
Standard Deviation 0.75
|
2.3 units on a scale
Standard Deviation 0.76
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 16: Anxiety/Depression
|
1.4 units on a scale
Standard Deviation 0.68
|
1.5 units on a scale
Standard Deviation 0.82
|
1.5 units on a scale
Standard Deviation 0.83
|
1.4 units on a scale
Standard Deviation 0.77
|
1.5 units on a scale
Standard Deviation 0.79
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 24: Mobility
|
1.5 units on a scale
Standard Deviation 0.63
|
1.6 units on a scale
Standard Deviation 0.79
|
1.6 units on a scale
Standard Deviation 0.75
|
1.5 units on a scale
Standard Deviation 0.66
|
1.7 units on a scale
Standard Deviation 0.75
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 24: Self-care
|
1.3 units on a scale
Standard Deviation 0.47
|
1.4 units on a scale
Standard Deviation 0.75
|
1.3 units on a scale
Standard Deviation 0.58
|
1.2 units on a scale
Standard Deviation 0.51
|
1.3 units on a scale
Standard Deviation 0.59
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 24: Usual activities
|
1.6 units on a scale
Standard Deviation 0.68
|
1.7 units on a scale
Standard Deviation 0.71
|
1.6 units on a scale
Standard Deviation 0.71
|
1.7 units on a scale
Standard Deviation 0.67
|
1.7 units on a scale
Standard Deviation 0.72
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 24: Pain/Discomfort
|
2.0 units on a scale
Standard Deviation 0.64
|
1.9 units on a scale
Standard Deviation 0.70
|
2.1 units on a scale
Standard Deviation 0.76
|
2.0 units on a scale
Standard Deviation 0.74
|
2.1 units on a scale
Standard Deviation 0.75
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 24: Anxiety/Depression
|
1.2 units on a scale
Standard Deviation 0.44
|
1.3 units on a scale
Standard Deviation 0.64
|
1.4 units on a scale
Standard Deviation 0.73
|
1.3 units on a scale
Standard Deviation 0.65
|
1.3 units on a scale
Standard Deviation 0.66
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 40: Mobility
|
1.5 units on a scale
Standard Deviation 0.76
|
1.5 units on a scale
Standard Deviation 0.62
|
1.5 units on a scale
Standard Deviation 0.75
|
1.5 units on a scale
Standard Deviation 0.70
|
1.6 units on a scale
Standard Deviation 0.73
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 40: Usual activities
|
1.6 units on a scale
Standard Deviation 0.69
|
1.6 units on a scale
Standard Deviation 0.73
|
1.6 units on a scale
Standard Deviation 0.72
|
1.7 units on a scale
Standard Deviation 0.68
|
1.7 units on a scale
Standard Deviation 0.76
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 40: Pain/Discomfort
|
1.9 units on a scale
Standard Deviation 0.62
|
1.9 units on a scale
Standard Deviation 0.64
|
2.0 units on a scale
Standard Deviation 0.73
|
1.9 units on a scale
Standard Deviation 0.75
|
2.0 units on a scale
Standard Deviation 0.72
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 40: Anxiety/Depression
|
1.2 units on a scale
Standard Deviation 0.49
|
1.3 units on a scale
Standard Deviation 0.60
|
1.3 units on a scale
Standard Deviation 0.64
|
1.3 units on a scale
Standard Deviation 0.68
|
1.4 units on a scale
Standard Deviation 0.63
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 56: Self-care
|
1.1 units on a scale
Standard Deviation 0.44
|
1.3 units on a scale
Standard Deviation 0.52
|
1.2 units on a scale
Standard Deviation 0.55
|
1.2 units on a scale
Standard Deviation 0.43
|
1.4 units on a scale
Standard Deviation 0.66
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 56: Mobility
|
1.4 units on a scale
Standard Deviation 0.61
|
1.5 units on a scale
Standard Deviation 0.72
|
1.5 units on a scale
Standard Deviation 0.69
|
1.4 units on a scale
Standard Deviation 0.67
|
1.6 units on a scale
Standard Deviation 0.83
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 56: Usual activities
|
1.6 units on a scale
Standard Deviation 0.82
|
1.6 units on a scale
Standard Deviation 0.69
|
1.6 units on a scale
Standard Deviation 0.78
|
1.6 units on a scale
Standard Deviation 0.73
|
1.7 units on a scale
Standard Deviation 0.82
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 56: Pain/Discomfort
|
2.0 units on a scale
Standard Deviation 0.77
|
1.9 units on a scale
Standard Deviation 0.66
|
2.0 units on a scale
Standard Deviation 0.72
|
1.9 units on a scale
Standard Deviation 0.72
|
2.0 units on a scale
Standard Deviation 0.74
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Week 56: Anxiety/Depression
|
1.3 units on a scale
Standard Deviation 0.54
|
1.3 units on a scale
Standard Deviation 0.55
|
1.4 units on a scale
Standard Deviation 0.77
|
1.3 units on a scale
Standard Deviation 0.70
|
1.3 units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants evaluable for this OM at specified time points.
EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score.EQ-5D-5L consists of 2 components: a health state profile and an optional VAS.EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.Individual dimension scores ranged from 1.0(least impairment of health state) to 5.0(most impairment of health state). Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems.Responses from five domains were used to calculate a single utility index (Overall health utility score) where values are less than equal to (\<=) 1.Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and reduced where participant reports greater levels of problems across five dimensions.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
Baseline
|
0.62 units on a scale
Standard Deviation 0.16
|
0.61 units on a scale
Standard Deviation 0.15
|
0.61 units on a scale
Standard Deviation 0.16
|
0.62 units on a scale
Standard Deviation 0.16
|
0.61 units on a scale
Standard Deviation 0.16
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
Week 8
|
0.74 units on a scale
Standard Deviation 0.13
|
0.71 units on a scale
Standard Deviation 0.14
|
0.75 units on a scale
Standard Deviation 0.13
|
0.76 units on a scale
Standard Deviation 0.14
|
0.74 units on a scale
Standard Deviation 0.14
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
Week 16
|
0.77 units on a scale
Standard Deviation 0.14
|
0.75 units on a scale
Standard Deviation 0.14
|
0.78 units on a scale
Standard Deviation 0.14
|
0.79 units on a scale
Standard Deviation 0.13
|
0.77 units on a scale
Standard Deviation 0.13
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
Week 24
|
0.82 units on a scale
Standard Deviation 0.10
|
0.81 units on a scale
Standard Deviation 0.13
|
0.80 units on a scale
Standard Deviation 0.13
|
0.82 units on a scale
Standard Deviation 0.12
|
0.80 units on a scale
Standard Deviation 0.12
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
Week 40
|
0.83 units on a scale
Standard Deviation 0.11
|
0.82 units on a scale
Standard Deviation 0.12
|
0.82 units on a scale
Standard Deviation 0.12
|
0.83 units on a scale
Standard Deviation 0.12
|
0.80 units on a scale
Standard Deviation 0.14
|
|
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
Week 56
|
0.85 units on a scale
Standard Deviation 0.11
|
0.82 units on a scale
Standard Deviation 0.13
|
0.82 units on a scale
Standard Deviation 0.14
|
0.84 units on a scale
Standard Deviation 0.12
|
0.81 units on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT population was analyzed.'n' = Participants evaluable for this OM for specified categories. Pre-specified intent of study was w compare tanezumab Vs placebo for data up to and including week 16 and comparisons of tanezumab Vs tramadol for data up to and including week 56. Number analyzed is 0 for placebo arm for week 16 and onwards.
WPAI: LBP is 6-question participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. It yields 4 sub-scores: work time missed due to pain (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Pre-specified intent of study for efficacy data up to Week 16 was to analyze, participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16 in placebo arm, in pooled manner. Hence data have been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data
Percent Work Time Missed
|
8.2 units on a scale
Standard Deviation 17.43
|
11.1 units on a scale
Standard Deviation 21.03
|
10.8 units on a scale
Standard Deviation 19.89
|
10.7 units on a scale
Standard Deviation 20.12
|
—
|
|
Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data
Percent Impairment While Working
|
57.9 units on a scale
Standard Deviation 21.25
|
60.8 units on a scale
Standard Deviation 19.68
|
60.6 units on a scale
Standard Deviation 20.56
|
61.2 units on a scale
Standard Deviation 19.83
|
—
|
|
Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data
Percent Overall Work Impairment
|
60.2 units on a scale
Standard Deviation 22.11
|
63.2 units on a scale
Standard Deviation 20.34
|
63.1 units on a scale
Standard Deviation 21.69
|
63.6 units on a scale
Standard Deviation 20.93
|
—
|
|
Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data
Percent Activity Impairment
|
65.7 units on a scale
Standard Deviation 18.13
|
66.6 units on a scale
Standard Deviation 17.57
|
65.1 units on a scale
Standard Deviation 18.33
|
65.4 units on a scale
Standard Deviation 18.31
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 56 and 64Population: ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
WPAI: LBP is 6-question participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. It yields 4 sub-scores: work time missed due to pain (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
Change at Week 16: Percent Work Time Missed
|
-5.82 units on a scale
Standard Error 1.18
|
-5.07 units on a scale
Standard Error 1.15
|
-5.89 units on a scale
Standard Error 1.16
|
-5.68 units on a scale
Standard Error 1.07
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
Change at Week 16:Percent Impairment While Working
|
-25.46 units on a scale
Standard Error 1.75
|
-29.49 units on a scale
Standard Error 1.71
|
-30.22 units on a scale
Standard Error 1.72
|
-27.11 units on a scale
Standard Error 1.58
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
Change at Week 16: Percent Overall Work Impairment
|
-26.54 units on a scale
Standard Error 1.80
|
-30.49 units on a scale
Standard Error 1.75
|
-31.95 units on a scale
Standard Error 1.77
|
-28.29 units on a scale
Standard Error 1.62
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
Change at Week 16: Percent Activity Impairment
|
-28.07 units on a scale
Standard Error 1.39
|
-32.25 units on a scale
Standard Error 1.38
|
-32.25 units on a scale
Standard Error 1.38
|
-30.83 units on a scale
Standard Error 1.23
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
Change at Week 56: Percent Work Time Missed
|
—
|
-8.06 units on a scale
Standard Error 1.11
|
-7.48 units on a scale
Standard Error 1.11
|
-7.19 units on a scale
Standard Error 1.05
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
Change at Week 56:Percent Impairment While Working
|
—
|
-39.38 units on a scale
Standard Error 2.03
|
-41.32 units on a scale
Standard Error 2.02
|
-38.51 units on a scale
Standard Error 1.89
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
Change at Week 56: Percent Overall Work Impairment
|
—
|
-41.18 units on a scale
Standard Error 2.18
|
-42.63 units on a scale
Standard Error 2.18
|
-39.25 units on a scale
Standard Error 2.04
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
Change at Week 56: Percent Activity Impairment
|
—
|
-43.53 units on a scale
Standard Error 1.75
|
-44.16 units on a scale
Standard Error 1.63
|
-43.00 units on a scale
Standard Error 1.47
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 56Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
Number of participants who withdrew from treatment due to lack of efficacy have been reported here.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants Who Withdrew Due to Lack of Efficacy
|
25 Participants
|
41 Participants
|
41 Participants
|
46 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 56Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Time to Discontinuation Due to Lack of Efficacy
|
NA days
Interval 14.0 to 123.0
Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to insufficient clinical response, lack of efficacy, median could not be calculated.
|
NA days
Interval 8.0 to 122.0
Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to insufficient clinical response, lack of efficacy, median could not be calculated.
|
NA days
Interval 14.0 to 252.0
Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to insufficient clinical response, lack of efficacy, median could not be calculated.
|
NA days
Interval 2.0 to 175.0
Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to insufficient clinical response, lack of efficacy, median could not be calculated.
|
NA days
Interval 2.0 to 314.0
Due to the Kaplan-Meier estimate not reaching the level for discontinuation due to insufficient clinical response, lack of efficacy, median could not be calculated.
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here,"N"=participants evaluable for this OM and "n" participants evaluable for OM at specified time points.
In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. Number of participants with any use of rescue medication during the particular study week were summarized. As pre specified intent of study, for analyses after week 16 where multiple imputation was used, data was reported per 3 arms. This is because participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16, received placebo for the first 16 weeks, and their data before week 16 were not be imputed into analyses after week 16.
Outcome measures
| Measure |
Placebo
n=407 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=604 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 2
|
226 Participants
|
208 Participants
|
318 Participants
|
—
|
—
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 4
|
205 Participants
|
175 Participants
|
285 Participants
|
—
|
—
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 8
|
176 Participants
|
158 Participants
|
250 Participants
|
—
|
—
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 12
|
150 Participants
|
147 Participants
|
216 Participants
|
—
|
—
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 16
|
134 Participants
|
125 Participants
|
193 Participants
|
—
|
—
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 24
|
145 Participants
|
150 Participants
|
211 Participants
|
—
|
—
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 32
|
146 Participants
|
152 Participants
|
210 Participants
|
—
|
—
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 40
|
145 Participants
|
144 Participants
|
209 Participants
|
—
|
—
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 48
|
141 Participants
|
144 Participants
|
210 Participants
|
—
|
—
|
|
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Week 56
|
142 Participants
|
142 Participants
|
215 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.
In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during the 4 weeks up to and including the particular study week were summarized.
Outcome measures
| Measure |
Placebo
n=61 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=60 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=136 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=151 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=193 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants Who Took Rescue Medication During Week 64: Observed Data
|
35 Participants
|
26 Participants
|
59 Participants
|
70 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.
In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. Number of days the participants used the rescue medication during the particular study weeks were summarized. As pre specified intent of study, for analyses after week 16 where multiple imputation was used, data was reported per 3 arms. This is because participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16, received placebo for the first 16 weeks, and their data before week 16 were not be imputed into analyses after week 16.
Outcome measures
| Measure |
Placebo
n=407 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=605 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 2
|
2.05 days
Standard Error 0.15
|
1.85 days
Standard Error 0.14
|
1.76 days
Standard Error 0.11
|
—
|
—
|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 4
|
1.62 days
Standard Error 0.13
|
1.40 days
Standard Error 0.12
|
1.46 days
Standard Error 0.10
|
—
|
—
|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 8
|
1.40 days
Standard Error 0.13
|
1.15 days
Standard Error 0.11
|
1.23 days
Standard Error 0.09
|
—
|
—
|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 12
|
1.25 days
Standard Error 0.13
|
1.02 days
Standard Error 0.11
|
1.11 days
Standard Error 0.09
|
—
|
—
|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 16
|
1.18 days
Standard Error 0.13
|
0.96 days
Standard Error 0.11
|
0.99 days
Standard Error 0.09
|
—
|
—
|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 24
|
1.36 days
Standard Error 0.15
|
1.35 days
Standard Error 0.14
|
1.32 days
Standard Error 0.12
|
—
|
—
|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 32
|
1.35 days
Standard Error 0.15
|
1.36 days
Standard Error 0.15
|
1.38 days
Standard Error 0.12
|
—
|
—
|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 40
|
1.39 days
Standard Error 0.15
|
1.24 days
Standard Error 0.14
|
1.37 days
Standard Error 0.12
|
—
|
—
|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 48
|
1.32 days
Standard Error 0.14
|
1.25 days
Standard Error 0.14
|
1.37 days
Standard Error 0.12
|
—
|
—
|
|
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Week 56
|
1.32 days
Standard Error 0.14
|
1.22 days
Standard Error 0.13
|
1.42 days
Standard Error 0.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'Overall number of participants analyzed' signifies participants who took rescue medication.
In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. Number of days per week the participants used the rescue medication during the 4 weeks up to and including the particular study week were summarized.
Outcome measures
| Measure |
Placebo
n=61 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=60 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=136 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=151 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=193 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Days of Rescue Medication Used at Week 64
|
1.3 days
Standard Deviation 1.59
|
1.3 days
Standard Deviation 2.02
|
1.3 days
Standard Deviation 1.99
|
1.4 days
Standard Deviation 2.16
|
1.8 days
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12 and 16Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. The total dosage of acetaminophen in milligrams used during the specified week were summarized. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16
Week 16
|
1385.0 milligrams
Standard Error 340.93
|
1537.8 milligrams
Standard Error 377.76
|
1359.0 milligrams
Standard Error 333.62
|
1296.8 milligrams
Standard Error 260.75
|
—
|
|
Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16
Week 12
|
1707.2 milligrams
Standard Error 379.30
|
1491.6 milligrams
Standard Error 330.87
|
1345.3 milligrams
Standard Error 297.82
|
1464.2 milligrams
Standard Error 265.85
|
—
|
|
Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16
Week 2
|
2420.1 milligrams
Standard Error 392.67
|
2663.2 milligrams
Standard Error 431.26
|
2465.7 milligrams
Standard Error 398.76
|
2340.4 milligrams
Standard Error 310.28
|
—
|
|
Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16
Week 4
|
2084.6 milligrams
Standard Error 374.33
|
1967.2 milligrams
Standard Error 352.25
|
1847.9 milligrams
Standard Error 330.64
|
1852.2 milligrams
Standard Error 271.70
|
—
|
|
Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16
Week 8
|
1757.9 milligrams
Standard Error 354.02
|
1682.3 milligrams
Standard Error 338.34
|
1612.5 milligrams
Standard Error 323.86
|
1512.4 milligrams
Standard Error 248.85
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 64 and 80Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants evaluable for this OM for specified categories.
Low back pain HCRU assessed utilization of healthcare resources usage during last 3 months (for Baseline during the last 3 months for baseline, weeks 64 and 80, via IRT). Visits of services directly related to low back pain evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner. Participants might have been counted more than once under various categories.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Primary Care Physician
|
1.0 visits
Interval 1.0 to 8.0
|
2.0 visits
Interval 1.0 to 114.0
|
2.0 visits
Interval 1.0 to 111.0
|
2.0 visits
Interval 1.0 to 14.0
|
2.0 visits
Interval 1.0 to 562.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Neurologist
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 4.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Rheumatologist
|
2.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 3.0
|
2.0 visits
Interval 1.0 to 5.0
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 6.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline:Physician assistant or nurse Practitioner
|
1.0 visits
Interval 1.0 to 6.0
|
2.0 visits
Interval 1.0 to 10.0
|
1.0 visits
Interval 1.0 to 5.0
|
1.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 6.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Pain specialist
|
2.0 visits
Interval 1.0 to 22.0
|
2.0 visits
Interval 1.0 to 25.0
|
2.0 visits
Interval 1.0 to 30.0
|
2.0 visits
Interval 1.0 to 222.0
|
2.0 visits
Interval 1.0 to 11.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Orthopedist
|
3.0 visits
Interval 1.0 to 8.0
|
3.0 visits
Interval 1.0 to 36.0
|
3.0 visits
Interval 1.0 to 15.0
|
2.0 visits
Interval 1.0 to 12.0
|
3.0 visits
Interval 1.0 to 16.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Physical therapist
|
6.5 visits
Interval 1.0 to 24.0
|
8.0 visits
Interval 1.0 to 36.0
|
4.5 visits
Interval 1.0 to 20.0
|
5.5 visits
Interval 1.0 to 111.0
|
3.5 visits
Interval 1.0 to 90.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Chiropractor
|
3.0 visits
Interval 1.0 to 10.0
|
3.0 visits
Interval 1.0 to 36.0
|
3.5 visits
Interval 1.0 to 30.0
|
3.0 visits
Interval 1.0 to 24.0
|
3.0 visits
Interval 1.0 to 121.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Rheumatologist
|
2.0 visits
Interval 1.0 to 14.0
|
1.0 visits
Interval 1.0 to 27.0
|
1.0 visits
Interval 1.0 to 100.0
|
1.0 visits
Interval 1.0 to 101.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Alternative medicine or therapy
|
2.0 visits
Interval 1.0 to 10.0
|
2.0 visits
Interval 1.0 to 121.0
|
3.0 visits
Interval 1.0 to 111.0
|
2.0 visits
Interval 1.0 to 45.0
|
2.0 visits
Interval 1.0 to 211.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Podiatrist
|
2.0 visits
Interval 1.0 to 3.0
|
—
|
2.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Nutritionist/dietitian
|
—
|
3.0 visits
Interval 1.0 to 100.0
|
1.5 visits
Interval 1.0 to 6.0
|
2.0 visits
Interval 1.0 to 4.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Radiologist
|
1.0 visits
Interval 1.0 to 3.0
|
1.5 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 10.0
|
1.0 visits
Interval 1.0 to 4.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Home healthcare services
|
7.5 visits
Interval 3.0 to 12.0
|
6.0 visits
Interval 1.0 to 11.0
|
—
|
1.0 visits
Interval 1.0 to 3.0
|
6.5 visits
Interval 1.0 to 36.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Baseline: Other practitioner
|
1.0 visits
Interval 1.0 to 6.0
|
2.0 visits
Interval 1.0 to 90.0
|
1.0 visits
Interval 1.0 to 8.0
|
2.0 visits
Interval 1.0 to 111.0
|
1.0 visits
Interval 1.0 to 36.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Primary Care Physician
|
1.0 visits
Interval 1.0 to 5.0
|
1.0 visits
Interval 1.0 to 299.0
|
1.0 visits
Interval 1.0 to 211.0
|
1.0 visits
Interval 1.0 to 201.0
|
1.0 visits
Interval 1.0 to 200.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Neurologist
|
1.0 visits
Interval 1.0 to 18.0
|
1.5 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 4.0
|
1.5 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 101.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Physician assistant or nurse Practitioner
|
1.0 visits
Interval 1.0 to 201.0
|
1.0 visits
Interval 1.0 to 8.0
|
2.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 3.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Pain specialist
|
1.0 visits
Interval 1.0 to 16.0
|
2.0 visits
Interval 1.0 to 100.0
|
2.0 visits
Interval 1.0 to 10.0
|
1.0 visits
Interval 1.0 to 201.0
|
1.0 visits
Interval 1.0 to 4.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Podiatrist
|
1.5 visits
Interval 1.0 to 2.0
|
2.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Orthopedist
|
2.0 visits
Interval 1.0 to 9.0
|
1.5 visits
Interval 1.0 to 27.0
|
1.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 201.0
|
2.0 visits
Interval 1.0 to 100.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Physical therapist
|
10.0 visits
Interval 1.0 to 18.0
|
8.0 visits
Interval 1.0 to 36.0
|
4.5 visits
Interval 1.0 to 20.0
|
4.0 visits
Interval 1.0 to 30.0
|
3.0 visits
Interval 1.0 to 999.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Chiropractor
|
6.0 visits
Interval 1.0 to 36.0
|
2.5 visits
Interval 1.0 to 100.0
|
2.0 visits
Interval 1.0 to 25.0
|
3.5 visits
Interval 1.0 to 92.0
|
2.0 visits
Interval 1.0 to 999.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Alternative medicine or therapy
|
6.0 visits
Interval 1.0 to 300.0
|
1.0 visits
Interval 1.0 to 2.0
|
2.0 visits
Interval 1.0 to 24.0
|
1.0 visits
Interval 1.0 to 5.0
|
1.0 visits
Interval 1.0 to 111.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Nutritionist/dietitian
|
—
|
1.0 visits
Interval 1.0 to 100.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 9.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Radiologist
|
1.0 visits
Interval 1.0 to 3.0
|
1.5 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Home healthcare services
|
8.0 visits
Interval 8.0 to 8.0
|
3.0 visits
Interval 1.0 to 5.0
|
1.0 visits
Interval 1.0 to 1.0
|
2.0 visits
Interval 1.0 to 3.0
|
16.5 visits
Interval 1.0 to 401.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 64: Other practitioner
|
1.0 visits
Interval 1.0 to 18.0
|
2.0 visits
Interval 1.0 to 100.0
|
1.0 visits
Interval 1.0 to 111.0
|
1.0 visits
Interval 1.0 to 16.0
|
1.0 visits
Interval 1.0 to 6.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Primary Care Physician
|
2.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 36.0
|
1.0 visits
Interval 1.0 to 101.0
|
1.0 visits
Interval 1.0 to 4.0
|
1.0 visits
Interval 1.0 to 12.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Neurologist
|
1.0 visits
Interval 1.0 to 1.0
|
2.0 visits
Interval 2.0 to 2.0
|
2.5 visits
Interval 2.0 to 3.0
|
2.0 visits
Interval 2.0 to 2.0
|
2.0 visits
Interval 1.0 to 3.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Rheumatologist
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Physician assistant or nurse Practitioner
|
5.0 visits
Interval 1.0 to 9.0
|
50.5 visits
Interval 1.0 to 100.0
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 1.0
|
2.0 visits
Interval 2.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Pain specialist
|
2.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 11.0
|
2.5 visits
Interval 1.0 to 4.0
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 3.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Orthopedist
|
1.0 visits
Interval 1.0 to 2.0
|
2.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 3.0
|
1.5 visits
Interval 1.0 to 2.0
|
1.5 visits
Interval 1.0 to 7.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Physical therapist
|
5.0 visits
Interval 1.0 to 8.0
|
12.0 visits
Interval 1.0 to 20.0
|
4.0 visits
Interval 1.0 to 16.0
|
5.0 visits
Interval 1.0 to 20.0
|
6.0 visits
Interval 6.0 to 14.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Chiropractor
|
401.0 visits
Interval 1.0 to 801.0
|
3.5 visits
Interval 1.0 to 9.0
|
4.0 visits
Interval 1.0 to 10.0
|
4.0 visits
Interval 1.0 to 20.0
|
3.0 visits
Interval 1.0 to 14.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Alternative medicine or therapy
|
9.0 visits
Interval 3.0 to 15.0
|
2.5 visits
Interval 1.0 to 30.0
|
3.0 visits
Interval 1.0 to 4.0
|
2.5 visits
Interval 2.0 to 3.0
|
2.0 visits
Interval 1.0 to 5.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Podiatrist
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.0 visits
Interval 1.0 to 1.0
|
1.5 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Nutritionist/dietitian
|
1.0 visits
Interval 1.0 to 1.0
|
10.0 visits
Interval 10.0 to 10.0
|
1.0 visits
Interval 1.0 to 1.0
|
4.0 visits
Interval 2.0 to 6.0
|
—
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Radiologist
|
1.0 visits
Interval 1.0 to 1.0
|
—
|
1.5 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Home healthcare services
|
1.0 visits
Interval 1.0 to 1.0
|
—
|
4.0 visits
Interval 4.0 to 4.0
|
—
|
24.5 visits
Interval 13.0 to 36.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Week 80: Other practitioner
|
1.0 visits
Interval 1.0 to 11.0
|
1.0 visits
Interval 1.0 to 2.0
|
1.0 visits
Interval 1.0 to 4.0
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 64 and 80Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' signifies the number of participants who had visited the emergency room at specified time points.
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who visited the emergency room due to low back pain.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain
Week 64
|
4 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain
Week 80
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain
Baseline
|
10 Participants
|
14 Participants
|
27 Participants
|
17 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 64 and 80Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Not all participants of the ITT population had data collected at each of the time points for this outcome measure. Hence, "N" signifies only those participants who were evaluable for this OM.
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of visits to the emergency room due to low back pain.
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=14 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=27 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=17 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=26 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain
Baseline
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 4.0
|
1.0 visits
Interval 1.0 to 5.0
|
1.0 visits
Interval 1.0 to 7.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain
Week 64
|
1.0 visits
Interval 1.0 to 1.0
|
2.0 visits
Interval 2.0 to 2.0
|
1.0 visits
Interval 1.0 to 3.0
|
1.0 visits
Interval 1.0 to 6.0
|
1.0 visits
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain
Week 80
|
—
|
1.0 visits
Interval 1.0 to 11.0
|
1.0 visits
Interval 1.0 to 2.0
|
—
|
1.5 visits
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 64 and 80Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n'= Participants who were evaluable for hospitalization due to low back pain at specified time points.
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who were hospitalized due to low back pain.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain
Baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain
Week 64
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain
Week 80
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 64 and 80Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Not all participants of the ITT population had data collected at each of the time points for this outcome measure. Hence, "N" signifies only those participants who were evaluable for this OM.
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of nights stayed in the hospital due to low back pain.
Outcome measures
| Measure |
Placebo
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=1 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=1 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=1 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=4 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain
Baseline
|
—
|
—
|
9.0 nights
Interval 9.0 to 9.0
|
—
|
1.0 nights
Interval 1.0 to 2.0
|
|
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain
Week 64
|
—
|
—
|
—
|
1.0 nights
Interval 1.0 to 1.0
|
1.0 nights
Interval 1.0 to 1.0
|
|
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain
Week 80
|
—
|
3.0 nights
Interval 3.0 to 3.0
|
2.0 nights
Interval 2.0 to 2.0
|
—
|
2.0 nights
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 64 and 80Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants who were evaluable for usage of any aids/devices for doing things.
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking aid use · Always
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline: Wheelchair use · Never
|
199 Participants
|
204 Participants
|
403 Participants
|
405 Participants
|
601 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to dress bathe eat · Rarely
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Walking aid use · Often
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Walking aid use · Always
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Wheelchair use · Never
|
61 Participants
|
59 Participants
|
134 Participants
|
142 Participants
|
190 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Wheelchair use · Rarely
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Wheelchair use · Sometimes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Wheelchair use · Often
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Wheelchair use · Always
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Device/Utensil to dress bathe eat · Never
|
60 Participants
|
57 Participants
|
132 Participants
|
142 Participants
|
190 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Device/Utensil to dress bathe eat · Rarely
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Device/Utensil to dress bathe eat · Sometimes
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Device/Utensil to dress bathe eat · Often
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Device/Utensil to dress bathe eat · Always
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Other aids or devices · Never
|
57 Participants
|
58 Participants
|
128 Participants
|
139 Participants
|
184 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Other aids or devices · Rarely
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Other aids or devices · Sometimes
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Other aids or devices · Often
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Other aids or devices · Always
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking aid use · Never
|
186 Participants
|
190 Participants
|
376 Participants
|
371 Participants
|
569 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking aid use · Rarely
|
2 Participants
|
2 Participants
|
11 Participants
|
9 Participants
|
7 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking aid use · Sometimes
|
6 Participants
|
4 Participants
|
12 Participants
|
16 Participants
|
15 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Walking aid use · Often
|
6 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
9 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline: Wheelchair use · Rarely
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline: Wheelchair use · Sometimes
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline: Wheelchair use · Often
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline: Wheelchair use · Always
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to dress bathe eat · Never
|
192 Participants
|
196 Participants
|
390 Participants
|
396 Participants
|
596 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to dress bathe eat · Sometimes
|
4 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to dress bathe eat · Often
|
5 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Device/Utensil to dress bathe eat · Always
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other aids or devices · Never
|
188 Participants
|
188 Participants
|
387 Participants
|
382 Participants
|
550 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other aids or devices · Rarely
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other aids or devices · Sometimes
|
2 Participants
|
5 Participants
|
10 Participants
|
11 Participants
|
27 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other aids or devices · Often
|
10 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
17 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Baseline:Other aids or devices · Always
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Walking aid use · Never
|
125 Participants
|
131 Participants
|
277 Participants
|
273 Participants
|
397 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Walking aid use · Rarely
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Walking aid use · Sometimes
|
5 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
9 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Walking aid use · Often
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Walking aid use · Always
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Device/Utensil to dress bathe eat · Always
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Wheelchair use · Never
|
135 Participants
|
138 Participants
|
283 Participants
|
283 Participants
|
412 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Wheelchair use · Rarely
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Wheelchair use · Sometimes
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Wheelchair use · Often
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Wheelchair use · Always
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Device/Utensil to dress bathe eat · Never
|
134 Participants
|
137 Participants
|
283 Participants
|
280 Participants
|
410 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Device/Utensil to dress bathe eat · Rarely
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Device/Utensil to dress bathe eat · Sometimes
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Device/Utensil to dress bathe eat · Often
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Other aids or devices · Never
|
125 Participants
|
135 Participants
|
277 Participants
|
273 Participants
|
387 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Other aids or devices · Rarely
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Other aids or devices · Sometimes
|
5 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Other aids or devices · Often
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 64: Other aids or devices · Always
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Walking aid use · Never
|
55 Participants
|
56 Participants
|
130 Participants
|
141 Participants
|
182 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Walking aid use · Rarely
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Week 80: Walking aid use · Sometimes
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 64 and 80Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants who were evaluable for quiting job due to low back pain.
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who quit job due to low back pain.
Outcome measures
| Measure |
Placebo
n=202 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=204 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=407 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=605 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain
Baseline
|
17 Participants
|
14 Participants
|
28 Participants
|
31 Participants
|
47 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain
Week 64
|
6 Participants
|
2 Participants
|
11 Participants
|
8 Participants
|
14 Participants
|
|
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain
Week 80
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 64 and 80Population: ITT population. Not all participants of the ITT population had data collected at each of the time points for this outcome measure. Hence, "N" signifies only those participants who were evaluable for this OM. Additional participants apart from the ones who had responded for quitting job responded to duration since quitting job.
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was duration since quitting job due to low back pain.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=15 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=28 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=31 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
n=47 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain
Week 80
|
8.6 years
Interval 5.8 to 99.1
|
4.7 years
Interval 1.0 to 8.3
|
0.2 years
Interval 0.0 to 3.3
|
3.5 years
Interval 0.8 to 17.1
|
3.5 years
Interval 3.0 to 5.0
|
|
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain
Baseline
|
2.0 years
Interval 0.2 to 15.0
|
2.0 years
Interval 0.3 to 15.6
|
1.0 years
Interval 0.1 to 20.5
|
3.8 years
Interval 0.1 to 16.0
|
2.3 years
Interval 0.1 to 90.3
|
|
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain
Week 64
|
1.1 years
Interval 0.1 to 13.2
|
5.2 years
Interval 2.5 to 7.1
|
2.2 years
Interval 0.2 to 32.0
|
2.0 years
Interval 0.1 to 17.0
|
2.5 years
Interval 0.2 to 25.2
|
SECONDARY outcome
Timeframe: Weeks 16 and 56Population: ITT population. Here, "N" signifies participants evaluable for this outcome measure. Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.
TSQM v.II: self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (7 questions scored on 7-point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied\]), effectiveness and side effects/tolerability (3 questions scored on 5 point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied\], 1 question on 2 point scale \[0 =No, 1=Yes\]). 11 questions of TSQM were used to calculate 4 endpoints of effectiveness, side effects, convenience and global satisfaction, each scored on a 0-100 scale with 100=best level of satisfaction. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
Outcome measures
| Measure |
Placebo
n=329 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=338 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=343 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=456 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
Week 16: Effectiveness
|
56.67 units on a scale
Standard Error 1.50
|
63.69 units on a scale
Standard Error 1.48
|
62.87 units on a scale
Standard Error 1.48
|
61.39 units on a scale
Standard Error 1.30
|
—
|
|
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
Week 16: Side Effects
|
66.95 units on a scale
Standard Error 3.76
|
79.26 units on a scale
Standard Error 3.31
|
79.51 units on a scale
Standard Error 3.31
|
70.83 units on a scale
Standard Error 2.15
|
—
|
|
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
Week 16: Convenience
|
73.11 units on a scale
Standard Error 1.16
|
75.68 units on a scale
Standard Error 1.16
|
76.37 units on a scale
Standard Error 1.15
|
74.63 units on a scale
Standard Error 1.04
|
—
|
|
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
Week 16: Global Satisfaction
|
64.90 units on a scale
Standard Error 1.41
|
70.32 units on a scale
Standard Error 1.39
|
68.64 units on a scale
Standard Error 1.38
|
67.12 units on a scale
Standard Error 1.22
|
—
|
|
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
Week 56: Effectiveness
|
—
|
72.66 units on a scale
Standard Error 2.12
|
72.51 units on a scale
Standard Error 2.01
|
71.21 units on a scale
Standard Error 1.79
|
—
|
|
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
Week 56: Side Effects
|
—
|
78.92 units on a scale
Standard Error 6.32
|
89.37 units on a scale
Standard Error 4.76
|
76.20 units on a scale
Standard Error 3.09
|
—
|
|
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
Week 56: Convenience
|
—
|
78.72 units on a scale
Standard Error 1.69
|
80.52 units on a scale
Standard Error 1.60
|
78.42 units on a scale
Standard Error 1.45
|
—
|
|
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
Week 56: Global Satisfaction
|
—
|
78.11 units on a scale
Standard Error 1.83
|
78.49 units on a scale
Standard Error 1.73
|
74.57 units on a scale
Standard Error 1.55
|
—
|
SECONDARY outcome
Timeframe: Weeks 16 and 56Population: ITT population. Here, "N" signifies participants evaluable for this outcome measure. Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.
The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess previous treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
Outcome measures
| Measure |
Placebo
n=322 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=333 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=340 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=450 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 56 · Prescription medicines and surgery
|
—
|
7 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 16 · Injectable prescription medicines
|
20 Participants
|
21 Participants
|
22 Participants
|
39 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 16 · Prescription medicines taken by mouth
|
213 Participants
|
211 Participants
|
229 Participants
|
287 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 16 · Surgery
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 16 · Prescription medicines and surgery
|
7 Participants
|
9 Participants
|
10 Participants
|
14 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 16 · No treatment
|
80 Participants
|
90 Participants
|
78 Participants
|
109 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 56 · Injectable prescription medicines
|
—
|
6 Participants
|
13 Participants
|
9 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 56 · Prescription medicines taken by mouth
|
—
|
91 Participants
|
102 Participants
|
147 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 56 · Surgery
|
—
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Week 56 · No treatment
|
—
|
35 Participants
|
40 Participants
|
44 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 16 and 56Population: ITT population. Here, "N" signifies participants evaluable for this outcome measure. Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.
mPRTI : self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction),participant global preference assessment (to assess previous treatment \& preference to continue using investigational product) \& participant willingness to use drug again assessment. To assess preference to continue using investigational product, participants responded using IRT on 5 point likert scale from 1-5, where, 1= yes, I definitely prefer drug that I am receiving now, 2= I have a slight preference for drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use investigational product. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
Outcome measures
| Measure |
Placebo
n=322 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=333 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=340 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=450 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 16 · Yes, definitely prefer the study drug
|
150 Participants
|
172 Participants
|
191 Participants
|
232 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 16 · Slight preference for the study drug
|
57 Participants
|
62 Participants
|
50 Participants
|
89 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 16 · No preference either way
|
62 Participants
|
66 Participants
|
55 Participants
|
82 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 16 · Slight preference for my previous treatment
|
24 Participants
|
14 Participants
|
23 Participants
|
17 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 16 · No, definitely prefer my previous treatment
|
29 Participants
|
19 Participants
|
21 Participants
|
30 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 56 · Yes, definitely prefer the study drug
|
—
|
90 Participants
|
104 Participants
|
129 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 56 · Slight preference for the study drug
|
—
|
30 Participants
|
36 Participants
|
42 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 56 · No preference either way
|
—
|
15 Participants
|
12 Participants
|
22 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 56 · Slight preference for my previous treatment
|
—
|
2 Participants
|
4 Participants
|
7 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Week 56 · No, definitely prefer my previous treatment
|
—
|
4 Participants
|
3 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 16 and 56Population: ITT population. Here, "N" signifies participants evaluable for this outcome measure. Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.
mPRTI: self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction),participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) \& participant willingness to use drug again assessment. To assess participants willingness to use drug again, participants responded using IRT on 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56.
Outcome measures
| Measure |
Placebo
n=322 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=333 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=340 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=450 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 16 · Yes, definitely want to use the same drug again
|
167 Participants
|
191 Participants
|
210 Participants
|
251 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 16 · Might want to use the same drug again
|
61 Participants
|
80 Participants
|
58 Participants
|
98 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 16 · I am not sure
|
51 Participants
|
36 Participants
|
38 Participants
|
64 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 16 · Might not want to use the same drug again
|
11 Participants
|
10 Participants
|
13 Participants
|
13 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 16 · No:definitely wouldn't want to use same drug again
|
32 Participants
|
16 Participants
|
21 Participants
|
24 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 56 · Yes, definitely want to use the same drug again
|
—
|
99 Participants
|
114 Participants
|
133 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 56 · Might want to use the same drug again
|
—
|
23 Participants
|
31 Participants
|
41 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 56 · I am not sure
|
—
|
15 Participants
|
10 Participants
|
26 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 56 · Might not want to use the same drug again
|
—
|
0 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Week 56 · No:definitely wouldn't want to use same drug again
|
—
|
4 Participants
|
2 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 80Population: Safety population analyzed.Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.'N' in placebo arm=number of participants who received only placebo for entire study.Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10 mg arm. 'N'=participants evaluable for this OM.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to week 80 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=506 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
7 Participants
|
21 Participants
|
37 Participants
|
25 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
125 Participants
|
319 Participants
|
347 Participants
|
421 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 56Population: The safety population was defined as all participants treated with tanezumab or placebo SC. Here, "Overall number of participants analyzed"=participants evaluable for this outcome measure.
Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to W56 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. Pre-specified intent of study for summaries for the entire treatment period (up to week 56), data was summarized by 3 arms.
Outcome measures
| Measure |
Placebo
n=506 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=602 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56
SAEs
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56
AEs
|
105 Participants
|
119 Participants
|
200 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 80Population: Safety population was analyzed."N"=participants evaluable for this OM. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Primary Abnormality criteria: HGB, hematocrit, RBC count \<0.8\* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width \<0.9\*LLN, \>1.1\*upper limit of normal(ULN); platelets \<0.5\*LLN,\>1.75\*ULN; WBC count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes,Leukocytes,Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils,Eosinophils,Monocytes\>1.2\*ULN; Prothrombin time/Intl. normalized ratio\>1.1\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides \>1.3\*ULN; Urate\>1.2\*ULN; sodium\<0.95\*LLN,\>1.05\*ULN; potassium,chloride,calcium,magnesium,bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate\<0.8\*LLN, \>1.2\*ULN; glucose\<0.6\*LLN, \>1.5\*ULN; HGB A1C \>1.3\*ULN; creatine kinase\>2.0\*ULN, specific gravity\<1.003, \>1.030; pH\<4.5, \>8; Urine Glucose, protein,HGB,bilirubin \>=1; Ketones\>=1;Urine erythrocytes,Leukocytes\>=20.
Outcome measures
| Measure |
Placebo
n=129 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=434 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=433 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=488 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
|
16 Participants
|
56 Participants
|
61 Participants
|
59 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 80Population: Safety population was analyzed."N"=participants evaluable for this OM. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Primary Abnormality criteria: hemoglobin; hematocrit; RBC count \< 0.8\*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*ULN; platelets \<0.5\*LLN,\>1.75\*upper limit of normal (ULN); white blood cell count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes, Leukocytes, Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils, Eosinophils, Monocytes \>1.2\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides \>1.3\*ULN; Urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN; Nitrite \>=1.
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=332 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=308 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=373 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
|
11 Participants
|
40 Participants
|
39 Participants
|
45 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80Population: Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. 'N' in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.
Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP). Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=506 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP: Baseline
|
122.3 millimeters of mercury (mmHg)
Standard Deviation 12.20
|
123.8 millimeters of mercury (mmHg)
Standard Deviation 13.25
|
122.6 millimeters of mercury (mmHg)
Standard Deviation 12.36
|
123.7 millimeters of mercury (mmHg)
Standard Deviation 13.77
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 2
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 10.50
|
-2.0 millimeters of mercury (mmHg)
Standard Deviation 11.05
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 10.62
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 11.37
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 4
|
-2.1 millimeters of mercury (mmHg)
Standard Deviation 11.36
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 11.46
|
-1.7 millimeters of mercury (mmHg)
Standard Deviation 10.65
|
-1.8 millimeters of mercury (mmHg)
Standard Deviation 11.81
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 8
|
-1.1 millimeters of mercury (mmHg)
Standard Deviation 11.37
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 11.38
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 11.02
|
-1.7 millimeters of mercury (mmHg)
Standard Deviation 11.99
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 16
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 10.56
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 10.75
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 11.10
|
-1.6 millimeters of mercury (mmHg)
Standard Deviation 11.96
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 24
|
—
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 10.51
|
-1.8 millimeters of mercury (mmHg)
Standard Deviation 11.53
|
-1.9 millimeters of mercury (mmHg)
Standard Deviation 12.67
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 32
|
—
|
-0.6 millimeters of mercury (mmHg)
Standard Deviation 11.36
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 11.53
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 12.54
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 40
|
—
|
-2.0 millimeters of mercury (mmHg)
Standard Deviation 11.27
|
-1.6 millimeters of mercury (mmHg)
Standard Deviation 11.91
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 11.99
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 48
|
—
|
-2.0 millimeters of mercury (mmHg)
Standard Deviation 12.12
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 11.51
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 12.46
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 56
|
—
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 11.18
|
-3.0 millimeters of mercury (mmHg)
Standard Deviation 12.03
|
-1.1 millimeters of mercury (mmHg)
Standard Deviation 12.03
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 64
|
—
|
-0.9 millimeters of mercury (mmHg)
Standard Deviation 11.51
|
-1.9 millimeters of mercury (mmHg)
Standard Deviation 12.28
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 11.59
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
SBP:Change at Week 80
|
—
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 10.82
|
0.1 millimeters of mercury (mmHg)
Standard Deviation 12.62
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 11.77
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP: Baseline
|
77.9 millimeters of mercury (mmHg)
Standard Deviation 9.10
|
78.6 millimeters of mercury (mmHg)
Standard Deviation 8.98
|
77.4 millimeters of mercury (mmHg)
Standard Deviation 8.48
|
78.2 millimeters of mercury (mmHg)
Standard Deviation 9.01
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 2
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 7.63
|
-1.1 millimeters of mercury (mmHg)
Standard Deviation 7.49
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 7.91
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 8.21
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 4
|
-1.7 millimeters of mercury (mmHg)
Standard Deviation 7.59
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 7.75
|
-1.1 millimeters of mercury (mmHg)
Standard Deviation 7.59
|
-0.9 millimeters of mercury (mmHg)
Standard Deviation 7.94
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 8
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 7.24
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 8.04
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 8.26
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 8.13
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 16
|
-0.6 millimeters of mercury (mmHg)
Standard Deviation 5.63
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 8.21
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 8.39
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 8.15
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 24
|
—
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 8.04
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 8.13
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 7.76
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 32
|
—
|
-0.6 millimeters of mercury (mmHg)
Standard Deviation 7.80
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 8.10
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 8.39
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 40
|
—
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 8.56
|
-1.1 millimeters of mercury (mmHg)
Standard Deviation 8.13
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 8.36
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 48
|
—
|
-2.1 millimeters of mercury (mmHg)
Standard Deviation 9.05
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 8.23
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 7.93
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 56
|
—
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 8.92
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 8.05
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 7.75
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 64
|
—
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 8.03
|
-0.0 millimeters of mercury (mmHg)
Standard Deviation 9.13
|
-0.6 millimeters of mercury (mmHg)
Standard Deviation 8.95
|
—
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
DBP:Change at Week 80
|
—
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 8.13
|
0.5 millimeters of mercury (mmHg)
Standard Deviation 9.07
|
-0.1 millimeters of mercury (mmHg)
Standard Deviation 8.55
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80Population: Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. 'N' in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.
Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=506 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Baseline
|
73.3 beats per minute
Standard Deviation 10.86
|
73.1 beats per minute
Standard Deviation 10.23
|
72.5 beats per minute
Standard Deviation 10.10
|
73.2 beats per minute
Standard Deviation 10.61
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 2
|
0.8 beats per minute
Standard Deviation 9.14
|
0.5 beats per minute
Standard Deviation 9.09
|
0.3 beats per minute
Standard Deviation 9.23
|
-0.2 beats per minute
Standard Deviation 9.24
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 4
|
1.6 beats per minute
Standard Deviation 9.32
|
0.6 beats per minute
Standard Deviation 8.82
|
0.4 beats per minute
Standard Deviation 9.47
|
0.2 beats per minute
Standard Deviation 9.57
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 8
|
1.2 beats per minute
Standard Deviation 8.88
|
0.1 beats per minute
Standard Deviation 9.41
|
-0.1 beats per minute
Standard Deviation 9.87
|
0.0 beats per minute
Standard Deviation 9.89
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 16
|
5.1 beats per minute
Standard Deviation 10.66
|
-0.6 beats per minute
Standard Deviation 9.99
|
-1.0 beats per minute
Standard Deviation 9.65
|
-0.8 beats per minute
Standard Deviation 10.13
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 24
|
—
|
0.0 beats per minute
Standard Deviation 9.32
|
-0.3 beats per minute
Standard Deviation 9.77
|
0.2 beats per minute
Standard Deviation 10.09
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 32
|
—
|
0.5 beats per minute
Standard Deviation 9.82
|
-0.3 beats per minute
Standard Deviation 9.94
|
0.6 beats per minute
Standard Deviation 9.72
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 40
|
—
|
1.2 beats per minute
Standard Deviation 10.14
|
-0.5 beats per minute
Standard Deviation 9.77
|
1.3 beats per minute
Standard Deviation 9.55
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 48
|
—
|
0.5 beats per minute
Standard Deviation 9.72
|
-0.5 beats per minute
Standard Deviation 10.79
|
0.9 beats per minute
Standard Deviation 10.33
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 56
|
—
|
0.4 beats per minute
Standard Deviation 10.31
|
0.2 beats per minute
Standard Deviation 10.50
|
0.7 beats per minute
Standard Deviation 11.10
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 64
|
—
|
1.1 beats per minute
Standard Deviation 10.66
|
0.8 beats per minute
Standard Deviation 10.08
|
0.7 beats per minute
Standard Deviation 10.22
|
—
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 80
|
—
|
1.1 beats per minute
Standard Deviation 10.93
|
1.2 beats per minute
Standard Deviation 9.83
|
0.9 beats per minute
Standard Deviation 11.48
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 56 and 80Population: Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. 'N' in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.
A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals {RR interval, PR interval, QRS interval, QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF)} were collected. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=506 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
RR Interval: Baseline
|
928.5 millisecond
Standard Deviation 150.40
|
911.4 millisecond
Standard Deviation 140.72
|
915.4 millisecond
Standard Deviation 138.41
|
918.9 millisecond
Standard Deviation 138.55
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
RR Interval:Change at Week 16
|
868.2 millisecond
Standard Deviation 235.72
|
897.1 millisecond
Standard Deviation 129.55
|
912.1 millisecond
Standard Deviation 142.81
|
894.9 millisecond
Standard Deviation 139.62
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
RR Interval:Change at Week 56
|
—
|
894.5 millisecond
Standard Deviation 138.03
|
893.0 millisecond
Standard Deviation 144.30
|
881.5 millisecond
Standard Deviation 136.11
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
RR Interval:Change at Week 80
|
—
|
870.5 millisecond
Standard Deviation 130.84
|
889.6 millisecond
Standard Deviation 143.10
|
876.5 millisecond
Standard Deviation 134.79
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
PR Interval: Baseline
|
156.2 millisecond
Standard Deviation 20.51
|
157.3 millisecond
Standard Deviation 23.32
|
158.1 millisecond
Standard Deviation 22.93
|
157.8 millisecond
Standard Deviation 23.44
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
PR Interval:Change at Week 16
|
158.8 millisecond
Standard Deviation 12.37
|
158.3 millisecond
Standard Deviation 21.99
|
159.6 millisecond
Standard Deviation 21.84
|
158.6 millisecond
Standard Deviation 23.37
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
PR Interval:Change at Week 56
|
—
|
158.5 millisecond
Standard Deviation 21.78
|
158.1 millisecond
Standard Deviation 20.85
|
159.2 millisecond
Standard Deviation 22.13
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
PR Interval:Change at Week 80
|
—
|
158.7 millisecond
Standard Deviation 22.15
|
157.7 millisecond
Standard Deviation 21.60
|
158.3 millisecond
Standard Deviation 21.46
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QRS Interval: Baseline
|
90.9 millisecond
Standard Deviation 8.72
|
92.5 millisecond
Standard Deviation 11.06
|
93.5 millisecond
Standard Deviation 12.30
|
93.1 millisecond
Standard Deviation 12.02
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QRS Interval:Change at Week 16
|
97.0 millisecond
Standard Deviation 8.29
|
93.4 millisecond
Standard Deviation 11.95
|
94.5 millisecond
Standard Deviation 13.27
|
93.9 millisecond
Standard Deviation 12.53
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QRS Interval:Change at Week 56
|
—
|
92.8 millisecond
Standard Deviation 12.71
|
95.4 millisecond
Standard Deviation 12.62
|
94.2 millisecond
Standard Deviation 13.73
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QRS Interval:Change at Week 80
|
—
|
93.0 millisecond
Standard Deviation 11.55
|
95.0 millisecond
Standard Deviation 12.53
|
94.4 millisecond
Standard Deviation 13.16
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QT Interval: Baseline
|
394.7 millisecond
Standard Deviation 29.67
|
393.1 millisecond
Standard Deviation 29.52
|
394.6 millisecond
Standard Deviation 27.54
|
393.7 millisecond
Standard Deviation 29.06
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QT Interval:Change at Week 16
|
379.8 millisecond
Standard Deviation 34.29
|
391.1 millisecond
Standard Deviation 28.13
|
393.5 millisecond
Standard Deviation 29.09
|
391.2 millisecond
Standard Deviation 30.30
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QT Interval:Change at Week 56
|
—
|
389.3 millisecond
Standard Deviation 27.11
|
392.8 millisecond
Standard Deviation 29.47
|
389.7 millisecond
Standard Deviation 29.44
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QT Interval:Change at Week 80
|
—
|
386.6 millisecond
Standard Deviation 27.67
|
393.0 millisecond
Standard Deviation 29.90
|
388.7 millisecond
Standard Deviation 29.33
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QTCB Interval: Baseline
|
411.7 millisecond
Standard Deviation 20.49
|
413.5 millisecond
Standard Deviation 20.19
|
414.4 millisecond
Standard Deviation 21.60
|
412.6 millisecond
Standard Deviation 22.39
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QTCB Interval:Change at Week 16
|
411.8 millisecond
Standard Deviation 17.50
|
414.5 millisecond
Standard Deviation 19.76
|
413.9 millisecond
Standard Deviation 22.67
|
415.3 millisecond
Standard Deviation 20.13
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QTCB Interval:Change at Week 56
|
—
|
413.5 millisecond
Standard Deviation 21.27
|
417.7 millisecond
Standard Deviation 22.02
|
416.8 millisecond
Standard Deviation 21.71
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QTCB Interval:Change at Week 80
|
—
|
416.1 millisecond
Standard Deviation 19.27
|
418.8 millisecond
Standard Deviation 22.13
|
417.0 millisecond
Standard Deviation 21.71
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QTCF Interval: Baseline
|
405.6 millisecond
Standard Deviation 18.22
|
406.3 millisecond
Standard Deviation 18.85
|
407.4 millisecond
Standard Deviation 18.93
|
405.9 millisecond
Standard Deviation 20.28
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QTCF Interval:Change at Week 16
|
400.3 millisecond
Standard Deviation 10.69
|
406.3 millisecond
Standard Deviation 18.45
|
406.7 millisecond
Standard Deviation 20.35
|
406.8 millisecond
Standard Deviation 19.04
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QTCF Interval:Change at Week 56
|
—
|
405.0 millisecond
Standard Deviation 18.46
|
408.9 millisecond
Standard Deviation 19.75
|
407.3 millisecond
Standard Deviation 19.74
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
QTCF Interval:Change at Week 80
|
—
|
405.7 millisecond
Standard Deviation 17.70
|
409.7 millisecond
Standard Deviation 19.74
|
407.1 millisecond
Standard Deviation 19.81
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 56 and 80Population: Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. 'N' in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.
Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=506 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80
Change at Week 56
|
—
|
68.6 beats per minute
Standard Deviation 10.29
|
68.9 beats per minute
Standard Deviation 11.02
|
69.7 beats per minute
Standard Deviation 11.26
|
—
|
|
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80
Baseline
|
66.4 beats per minute
Standard Deviation 11.34
|
67.4 beats per minute
Standard Deviation 10.34
|
67.1 beats per minute
Standard Deviation 10.31
|
66.9 beats per minute
Standard Deviation 10.64
|
—
|
|
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80
Change at Week 16
|
72.3 beats per minute
Standard Deviation 14.42
|
68.3 beats per minute
Standard Deviation 10.00
|
67.4 beats per minute
Standard Deviation 10.35
|
68.8 beats per minute
Standard Deviation 10.99
|
—
|
|
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80
Change at Week 80
|
—
|
70.5 beats per minute
Standard Deviation 10.57
|
69.3 beats per minute
Standard Deviation 11.61
|
70.1 beats per minute
Standard Deviation 10.98
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80Population: Safety population analyzed. 'N' in placebo arm=participants who received only placebo for entire study, those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm. Hence, N=participants evaluable for this OM.
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP \<=150 mmHg (mean supine): Reduction in systolic BP\>=20 mmHg or reduction in diastolic BP\>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP \>150 mmHg (mean supine): Reduction in systolic BP\>=30 mmHg or reduction in diastolic BP\>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=503 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=501 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=601 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants With Confirmed Orthostatic Hypotension
Baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 4
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 16
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 32
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 48
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 56
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 64
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Week 80
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Screening (up to maximum of 37 days prior to Baseline), Weeks 24, 56 and 80Population: Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. 'N' in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.
The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=506 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Number of symptoms reported: Screening
|
0.45 units on a scale
Standard Deviation 0.79
|
0.43 units on a scale
Standard Deviation 0.75
|
0.50 units on a scale
Standard Deviation 0.82
|
0.48 units on a scale
Standard Deviation 0.74
|
—
|
|
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Number of symptoms reported: Change at Week 24
|
—
|
0.32 units on a scale
Standard Deviation 1.45
|
0.28 units on a scale
Standard Deviation 1.37
|
0.51 units on a scale
Standard Deviation 1.34
|
—
|
|
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Number of symptoms reported: Change at Week 56
|
—
|
0.50 units on a scale
Standard Deviation 1.57
|
0.30 units on a scale
Standard Deviation 1.37
|
0.60 units on a scale
Standard Deviation 1.49
|
—
|
|
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Number of symptoms reported: Change at Week 80
|
—
|
0.41 units on a scale
Standard Deviation 1.38
|
0.42 units on a scale
Standard Deviation 1.45
|
0.45 units on a scale
Standard Deviation 1.47
|
—
|
|
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Total Symptom Impact Score: Screening
|
0.93 units on a scale
Standard Deviation 1.62
|
0.95 units on a scale
Standard Deviation 1.69
|
1.10 units on a scale
Standard Deviation 1.88
|
1.06 units on a scale
Standard Deviation 1.71
|
—
|
|
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Total Symptom Impact Score: Change at Week 24
|
—
|
1.03 units on a scale
Standard Deviation 4.05
|
0.76 units on a scale
Standard Deviation 3.55
|
1.37 units on a scale
Standard Deviation 3.68
|
—
|
|
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Total Symptom Impact Score: Change at Week 56
|
—
|
1.49 units on a scale
Standard Deviation 4.53
|
0.96 units on a scale
Standard Deviation 3.87
|
1.74 units on a scale
Standard Deviation 3.96
|
—
|
|
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Total Symptom Impact Score: Change at Week 80
|
—
|
1.47 units on a scale
Standard Deviation 4.26
|
1.28 units on a scale
Standard Deviation 4.10
|
1.43 units on a scale
Standard Deviation 3.94
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 80Population: Safety population was analyzed. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms. 'N' in placebo arm=participants who received only placebo for entire study, those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.
Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive OA (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=506 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Primary Osteonecrosis
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 0.7
|
0 percentage of participants
Interval 0.0 to 0.7
|
0 percentage of participants
Interval 0.0 to 0.6
|
—
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Composite Joint Safety Endpoint
|
0 percentage of participants
Interval 0.0 to 1.7
|
1.0 percentage of participants
Interval 0.3 to 2.3
|
2.6 percentage of participants
Interval 1.4 to 4.4
|
0.2 percentage of participants
Interval 0.0 to 0.9
|
—
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Rapidly Progressive OA
|
0 percentage of participants
Interval 0.0 to 1.7
|
1.0 percentage of participants
Interval 0.3 to 2.3
|
1.8 percentage of participants
Interval 0.8 to 3.4
|
0.2 percentage of participants
Interval 0.0 to 0.9
|
—
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Rapidly Progressive OA type 1
|
0 percentage of participants
Interval 0.0 to 1.7
|
1.0 percentage of participants
Interval 0.3 to 2.3
|
1.4 percentage of participants
Interval 0.6 to 2.9
|
0.2 percentage of participants
Interval 0.0 to 0.9
|
—
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Rapidly Progressive OA type 2
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 0.7
|
0.4 percentage of participants
Interval 0.0 to 1.4
|
0 percentage of participants
Interval 0.0 to 0.6
|
—
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Pathological Fracture
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 0.7
|
0 percentage of participants
Interval 0.0 to 0.7
|
0 percentage of participants
Interval 0.0 to 0.6
|
—
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Subchondral Insufficiency Fracture
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 0.7
|
0.8 percentage of participants
Interval 0.2 to 2.0
|
0 percentage of participants
Interval 0.0 to 0.6
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 80Population: Safety population. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms. N in placebo arm=number of participants who received only placebo for entire study, those who were there up to W16,but switched to tanezumab treatment after W16 are included in tanezumab 5/10 mg arm.
Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=506 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Total Joint Replacements
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 0.7
|
1.4 percentage of participants
Interval 0.6 to 2.9
|
0 percentage of participants
Interval 0.0 to 0.6
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80Population: Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. 'N' in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.
NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Outcome measures
| Measure |
Placebo
n=215 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=506 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=502 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Baseline
|
1.00 units on a scale
Standard Deviation 3.55
|
0.58 units on a scale
Standard Deviation 2.28
|
0.86 units on a scale
Standard Deviation 2.54
|
0.78 units on a scale
Standard Deviation 2.62
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 2
|
0.02 units on a scale
Standard Deviation 1.29
|
0.05 units on a scale
Standard Deviation 1.12
|
-0.08 units on a scale
Standard Deviation 1.34
|
-0.15 units on a scale
Standard Deviation 1.31
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 4
|
-0.14 units on a scale
Standard Deviation 1.35
|
-0.02 units on a scale
Standard Deviation 0.96
|
-0.17 units on a scale
Standard Deviation 1.57
|
-0.16 units on a scale
Standard Deviation 1.36
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 8
|
0.01 units on a scale
Standard Deviation 1.97
|
-0.09 units on a scale
Standard Deviation 1.41
|
-0.17 units on a scale
Standard Deviation 1.99
|
0.08 units on a scale
Standard Deviation 3.53
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 16
|
-0.02 units on a scale
Standard Deviation 1.91
|
-0.06 units on a scale
Standard Deviation 1.37
|
-0.06 units on a scale
Standard Deviation 1.94
|
0.02 units on a scale
Standard Deviation 1.84
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 24
|
—
|
-0.10 units on a scale
Standard Deviation 1.58
|
-0.09 units on a scale
Standard Deviation 1.77
|
0.03 units on a scale
Standard Deviation 2.32
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 32
|
—
|
-0.14 units on a scale
Standard Deviation 1.60
|
-0.12 units on a scale
Standard Deviation 1.73
|
0.03 units on a scale
Standard Deviation 1.90
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 40
|
—
|
-0.13 units on a scale
Standard Deviation 1.44
|
-0.13 units on a scale
Standard Deviation 1.81
|
-0.02 units on a scale
Standard Deviation 1.97
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 48
|
—
|
-0.14 units on a scale
Standard Deviation 1.33
|
-0.10 units on a scale
Standard Deviation 1.85
|
0.00 units on a scale
Standard Deviation 1.92
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 56
|
—
|
-0.16 units on a scale
Standard Deviation 1.38
|
-0.09 units on a scale
Standard Deviation 2.07
|
-0.03 units on a scale
Standard Deviation 1.97
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 64
|
—
|
-0.07 units on a scale
Standard Deviation 2.39
|
-0.09 units on a scale
Standard Deviation 2.06
|
-0.06 units on a scale
Standard Deviation 2.03
|
—
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change at Week 80
|
—
|
-0.09 units on a scale
Standard Deviation 1.94
|
-0.12 units on a scale
Standard Deviation 2.15
|
-0.07 units on a scale
Standard Deviation 2.06
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 32, 40, 48, 56, 64 and 80Population: The safety population was defined as all participants treated with tanezumab or placebo SC. Here, 'n' = participants who had at least one ADA sample for ADA assessment at specified timepoints. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16.
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level \>=3.32. Less than 3.32 was considered below the limit of quantitation. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Outcome measures
| Measure |
Placebo
n=409 Participants
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
|
Pooled Tanezumab 5 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Pooled Tanezumab 10 mg
n=407 Participants
Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 Participants
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
Tramadol
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|---|
|
Number of Participants With Anti Tanezumab Antibodies
Week 80
|
—
|
14 Participants
|
14 Participants
|
19 Participants
|
—
|
|
Number of Participants With Anti Tanezumab Antibodies
Baseline
|
45 Participants
|
38 Participants
|
39 Participants
|
68 Participants
|
—
|
|
Number of Participants With Anti Tanezumab Antibodies
Week 8
|
37 Participants
|
32 Participants
|
54 Participants
|
49 Participants
|
—
|
|
Number of Participants With Anti Tanezumab Antibodies
Week 16
|
27 Participants
|
36 Participants
|
46 Participants
|
32 Participants
|
—
|
|
Number of Participants With Anti Tanezumab Antibodies
Week 32
|
—
|
32 Participants
|
48 Participants
|
23 Participants
|
—
|
|
Number of Participants With Anti Tanezumab Antibodies
Week 48
|
—
|
31 Participants
|
49 Participants
|
23 Participants
|
—
|
|
Number of Participants With Anti Tanezumab Antibodies
Week 56
|
—
|
22 Participants
|
41 Participants
|
21 Participants
|
—
|
|
Number of Participants With Anti Tanezumab Antibodies
Week 64
|
—
|
15 Participants
|
32 Participants
|
19 Participants
|
—
|
Adverse Events
Placebo (Week 16)
Serious events: 7 serious events
Other events: 65 other events
Deaths: 1 deaths
Safety Evaluation: Tanezumab 5 mg
Serious events: 21 serious events
Other events: 201 other events
Deaths: 2 deaths
Safety Evaluation: Tanezumab 10 mg
Serious events: 37 serious events
Other events: 203 other events
Deaths: 2 deaths
Tramadol
Serious events: 25 serious events
Other events: 275 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo (Week 16)
n=215 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16, inclusive of those participants who were randomized to placebo but received tramadol.
|
Safety Evaluation: Tanezumab 5 mg
n=506 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (\>=30 % reduction in average LBPI score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Safety Evaluation: Tanezumab 10 mg
n=502 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (\>=30 % reduction in average LBPI score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 10 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 participants at risk
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Cardiac disorders
Cardiac failure
|
0.47%
1/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.33%
2/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Eye disorders
Pupils unequal
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Eye disorders
Uveitis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
General disorders
Chest pain
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Amoebic colitis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Influenza
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.47%
1/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.40%
2/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.60%
3/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Rapidly progressive osteoarthritis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
1.00%
5/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.60%
3/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Subchondral insufficiency fracture
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.40%
2/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Nervous system disorders
Seizure
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Nervous system disorders
Syncope
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Psychiatric disorders
Depression
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Vascular disorders
Aneurysm ruptured
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.20%
1/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.17%
1/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.47%
1/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.47%
1/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Psychiatric disorders
Depression suicidal
|
0.47%
1/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Vascular disorders
Aortic aneurysm
|
0.47%
1/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.47%
1/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.00%
0/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
Other adverse events
| Measure |
Placebo (Week 16)
n=215 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16, inclusive of those participants who were randomized to placebo but received tramadol.
|
Safety Evaluation: Tanezumab 5 mg
n=506 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (\>=30 % reduction in average LBPI score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Safety Evaluation: Tanezumab 10 mg
n=502 participants at risk
Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (\>=30 % reduction in average LBPI score and \>=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 10 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
|
Tramadol
n=602 participants at risk
Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.4%
3/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
1.8%
9/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
2.4%
12/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
8.6%
52/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
5/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
3.2%
16/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
3.2%
16/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
13.0%
78/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
11/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
6.1%
31/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
6.4%
32/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
6.1%
37/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
4/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
4.9%
25/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
6.8%
34/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
5.0%
30/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
4/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
5.1%
26/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
4.0%
20/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
3.0%
18/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
22/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
13.4%
68/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
14.1%
71/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
10.8%
65/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
15/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
7.7%
39/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
6.6%
33/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
5.5%
33/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
12/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
7.1%
36/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
5.4%
27/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
5.1%
31/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Nervous system disorders
Dizziness
|
1.9%
4/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
2.4%
12/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
2.2%
11/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
7.3%
44/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Nervous system disorders
Headache
|
6.0%
13/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
7.7%
39/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
7.2%
36/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
8.3%
50/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
|
Nervous system disorders
Somnolence
|
2.8%
6/215 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
0.99%
5/506 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
1.4%
7/502 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
5.5%
33/602 • Baseline up to Week 80
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. N in placebo arm=participants who received only placebo for entire study, those who were there upto W16,but switched to tanezumab after W16 included in tanezumab 5/10mg arm.
|
Additional Information
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