Low Back Pain
Conditions
Keywords
Chronic low back pain, Chronic pain
Brief summary
This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
Detailed description
This is a randomized, double blind, placebo and active controlled, multicenter, parallel group Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800 subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and 600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16. At the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56; 2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week interval to Week 56. The study is designed with a total duration (post randomization) of up to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days; includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and Efficacy Phase), and a Follow up Period (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must have a documented history of previous inadequate treatment response to medications in 3 different categories of agents commonly used to treat and generally considered effective for the treatment of chronic low back pain.
Interventions
BIOLOGICALPlacebo to Week 16; tanezumab 5mg SC
Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections
BIOLOGICALPlacebo to Week 16, tanezumab 10 mg SC
Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections
BIOLOGICALTanezumab 5 mg SC
Tanezumab 5 mg SC
BIOLOGICALTanezumab 10 mg SC
Tanezumab 10 mg SC
BIOLOGICALTramadol PR oral
Tramadol PR oral
Sponsors
Eli Lilly and Company
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Chronic low back pain ≥3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.
Exclusion criteria
--Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria. * Subjects who have Kellgren Lawrence Grade \> or =2 radiographic evidence of hip or Grade \> or=3 radiographic evidence of knee osteoarthritis will be excluded; * History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., rheumatoid arthritis). * History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study. * Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study * History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol * Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | Baseline, Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 | Baseline, Week 16 | 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. |
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Baseline, Week 64 | 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. |
| 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 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Baseline, Weeks 64 and 80 | 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. |
| 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 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Baseline, Week 64 | 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. |
| 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) | Baseline, Weeks 16, 24 and 56 | 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. |
| 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) | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | 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. |
| 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) | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56 | Baseline, Weeks 16, 24 and 56 | 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. |
| 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 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Baseline, Week 64 | 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. |
| 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 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Baseline, Week 64 | 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. |
| 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 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Baseline, Week 64 | 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. |
| 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 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data | Baseline, Week 64 | 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. |
| 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 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data | Baseline, Week 64 | 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. |
| 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 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data | Baseline, Week 64 | 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. |
| 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 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data | Baseline, Week 64 | 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. |
| Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| 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) | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 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. |
| European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline, Weeks 8, 16, 24, 40 and 56 | 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. |
| European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Baseline, Weeks 8, 16, 24, 40, 56 and 64 | 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. |
| Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Baseline | 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. |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64 | Baseline, Weeks 16, 56 and 64 | 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. |
| Number of Participants Who Withdrew Due to Lack of Efficacy | Baseline up to Week 56 | Number of participants who withdrew from treatment due to lack of efficacy have been reported here. |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 56 | 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. |
| Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | 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. |
| Number of Participants Who Took Rescue Medication During Week 64: Observed Data | Week 64 | 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. |
| Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | 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. |
| Number of Days of Rescue Medication Used at Week 64 | Week 64 | 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. |
| Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Weeks 2, 4, 8, 12 and 16 | 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. |
| Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline, Weeks 64 and 80 | 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. |
| Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Baseline, Weeks 64 and 80 | 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. |
| Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Baseline, Weeks 64 and 80 | 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. |
| Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Baseline, Weeks 64 and 80 | 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. |
| Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain | Baseline, Weeks 64 and 80 | 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. |
| Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline, Weeks 64 and 80 | 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. |
| Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Baseline, Weeks 64 and 80 | 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. |
| Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Baseline, Weeks 64 and 80 | 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. |
| Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Weeks 16 and 56 | 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. |
| 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? | Weeks 16 and 56 | 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. |
| 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? | Weeks 16 and 56 | 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. |
| 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? | Weeks 16 and 56 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 80 | 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. |
| Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56 | Baseline up to Week 56 | 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. |
| Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | Baseline up to Week 80 | 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. |
| Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | Baseline up to Week 80 | 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. |
| Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | 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. |
| Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms. |
| Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | Baseline, Week 16 | 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. |
| Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Baseline, Weeks 16, 56 and 80 | Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms. |
| Percentage of Participants With Total Joint Replacements | Baseline up to Week 80 | Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery. |
| Number of Participants With Confirmed Orthostatic Hypotension | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | 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. |
| Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Screening (up to maximum of 37 days prior to Baseline), Weeks 24, 56 and 80 | 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. |
| Percentage of Participants With Adjudicated Joint Safety Outcomes | Baseline up to Week 80 | 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. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | 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. |
| Number of Participants With Anti Tanezumab Antibodies | Baseline, Weeks 8, 16, 32, 40, 48, 56, 64 and 80 | 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. |
| Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | Baseline, Weeks 16, 56 and 80 | 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. |
Countries
Canada, Denmark, France, Hungary, Japan, South Korea, Spain, Sweden, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Followed by Tanezumab 5 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 \>=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. | 205 |
| 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. | 204 |
| 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. | 407 |
| 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. | 407 |
| 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. | 602 |
| Total | 1,825 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| 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 | Protocol Violation | 1 | 2 | 4 | 0 | 4 |
| Overall Study | Withdrawal by Subject | 25 | 20 | 29 | 48 | 73 |
| Overall Study | Withdrawn Due to Pregnancy | 0 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo Followed by Tanezumab 5 mg | Placebo Followed by Tanezumab 10 mg | Pooled Tanezumab 5 mg | Pooled Tanezumab 10 mg | Tramadol | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 49.01 years STANDARD_DEVIATION 13.76 | 48.97 years STANDARD_DEVIATION 12 | 48.66 years STANDARD_DEVIATION 12.36 | 49.15 years STANDARD_DEVIATION 12.36 | 48.42 years STANDARD_DEVIATION 13.08 | 48.77 years STANDARD_DEVIATION 12.72 |
| Race/Ethnicity, Customized Asian | 13 Participants | 25 Participants | 39 Participants | 28 Participants | 65 Participants | 170 Participants |
| Race/Ethnicity, Customized Black or African American | 35 Participants | 35 Participants | 65 Participants | 66 Participants | 102 Participants | 303 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 2 Participants | 8 Participants | 10 Participants | 7 Participants | 30 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 154 Participants | 142 Participants | 295 Participants | 303 Participants | 428 Participants | 1322 Participants |
| Sex: Female, Male Female | 123 Participants | 113 Participants | 248 Participants | 218 Participants | 339 Participants | 1041 Participants |
| Sex: Female, Male Male | 82 Participants | 91 Participants | 159 Participants | 189 Participants | 263 Participants | 784 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 215 | 2 / 506 | 2 / 502 | 1 / 602 |
| other Total, other adverse events | 65 / 215 | 201 / 506 | 203 / 502 | 275 / 602 |
| serious Total, serious adverse events | 7 / 215 | 21 / 506 | 37 / 502 | 25 / 602 |
Outcome results
Primary
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16
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.
Time frame: Baseline, Week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | -2.98 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | -3.08 units on a scale | Standard Error 0.14 |
| Tramadol | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | -2.81 units on a scale | Standard Error 0.12 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.p-value: 0.111795% CI: [-0.66, 0.07]ANCOVA
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.p-value: 0.028195% CI: [-0.76, -0.04]ANCOVA
Secondary
Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16
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.
Time frame: Weeks 2, 4, 8, 12 and 16
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 8 | 1757.9 milligrams | Standard Error 354.02 |
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 2 | 2420.1 milligrams | Standard Error 392.67 |
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 16 | 1385.0 milligrams | Standard Error 340.93 |
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 4 | 2084.6 milligrams | Standard Error 374.33 |
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 12 | 1707.2 milligrams | Standard Error 379.3 |
| Pooled Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 2 | 2663.2 milligrams | Standard Error 431.26 |
| Pooled Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 8 | 1682.3 milligrams | Standard Error 338.34 |
| Pooled Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 16 | 1537.8 milligrams | Standard Error 377.76 |
| Pooled Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 12 | 1491.6 milligrams | Standard Error 330.87 |
| Pooled Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 4 | 1967.2 milligrams | Standard Error 352.25 |
| Pooled Tanezumab 10 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 16 | 1359.0 milligrams | Standard Error 333.62 |
| Pooled Tanezumab 10 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 2 | 2465.7 milligrams | Standard Error 398.76 |
| Pooled Tanezumab 10 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 4 | 1847.9 milligrams | Standard Error 330.64 |
| Pooled Tanezumab 10 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 8 | 1612.5 milligrams | Standard Error 323.86 |
| Pooled Tanezumab 10 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 12 | 1345.3 milligrams | Standard Error 297.82 |
| Tramadol | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 8 | 1512.4 milligrams | Standard Error 248.85 |
| Tramadol | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 12 | 1464.2 milligrams | Standard Error 265.85 |
| Tramadol | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 2 | 2340.4 milligrams | Standard Error 310.28 |
| Tramadol | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 16 | 1296.8 milligrams | Standard Error 260.75 |
| Tramadol | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 | Week 4 | 1852.2 milligrams | Standard Error 271.7 |
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.676495% CI: [0.7, 1.73]Negative binomial model
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.935195% CI: [0.65, 1.6]Negative binomial model
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.873195% CI: [0.64, 1.46]Negative binomial model
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.53795% CI: [0.75, 1.72]Negative binomial model
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.803195% CI: [0.7, 1.59]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.819295% CI: [0.57, 1.55]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.634595% CI: [0.54, 1.46]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.610395% CI: [0.56, 1.4]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.794995% CI: [0.67, 1.67]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.99295% CI: [0.63, 1.57]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.877295% CI: [0.55, 1.67]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.761495% CI: [0.53, 1.6]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.562995% CI: [0.52, 1.43]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.682195% CI: [0.67, 1.85]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.804995% CI: [0.64, 1.77]Negative binomial model
Comparison: Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.667395% CI: [0.47, 1.62]Negative binomial model
Comparison: Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.447595% CI: [0.43, 1.46]Negative binomial model
Comparison: Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.592595% CI: [0.49, 1.5]Negative binomial model
Comparison: Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.948695% CI: [0.58, 1.79]Negative binomial model
Comparison: Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.767395% CI: [0.52, 1.61]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.763595% CI: [0.56, 2.2]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.956495% CI: [0.5, 1.94]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.835995% CI: [0.5, 1.75]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.591495% CI: [0.64, 2.21]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.882695% CI: [0.56, 1.95]Negative binomial model
Secondary
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
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.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.64 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | 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 | -1.54 units on a scale | Standard Error 0.09 |
| Pooled Tanezumab 5 mg | 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 | -2.92 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.24 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -2.75 units on a scale | Standard Error 0.16 |
| Pooled Tanezumab 10 mg | 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 | -3.12 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 10 mg | 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 | -2.67 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.62 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.62 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.43 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | 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 | -2.79 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 10 mg | 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 | -2.92 units on a scale | Standard Error 0.16 |
| Pooled Tanezumab 10 mg | 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 | -1.59 units on a scale | Standard Error 0.09 |
| Tramadol | 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 | -2.40 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -1.36 units on a scale | Standard Error 0.08 |
| Tramadol | 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 | -1.99 units on a scale | Standard Error 0.1 |
| Tramadol | 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 | -2.43 units on a scale | Standard Error 0.11 |
| Tramadol | 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 | -2.74 units on a scale | Standard Error 0.11 |
| Tramadol | 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 | -2.64 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.52 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.49 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.43 units on a scale | Standard Error 0.15 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.001595% CI: [-0.6, -0.14]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.000495% CI: [-0.65, -0.19]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.095995% CI: [-0.39, 0.03]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.03795% CI: [-0.44, -0.01]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.000895% CI: [-0.76, -0.2]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.96, -0.39]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.071195% CI: [-0.5, 0.02]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.066195% CI: [-0.5, 0.02]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.000995% CI: [-0.7, -0.18]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.000895% CI: [-0.84, -0.22]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: <0.000195% CI: [-1, -0.38]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.027495% CI: [-0.61, -0.04]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.149595% CI: [-0.5, 0.08]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.012395% CI: [-0.65, -0.08]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.030795% CI: [-0.71, -0.03]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.000995% CI: [-0.91, -0.24]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.210395% CI: [-0.51, 0.11]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.265695% CI: [-0.48, 0.13]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.015295% CI: [-0.68, -0.07]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.516495% CI: [-0.5, 0.25]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.148895% CI: [-0.66, 0.1]ANCOVA
Comparison: Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.243195% CI: [-0.6, 0.15]ANCOVA
Comparison: Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.242895% CI: [-0.62, 0.16]ANCOVA
Comparison: Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.456195% CI: [-0.54, 0.24]ANCOVA
Comparison: Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.352395% CI: [-0.56, 0.2]ANCOVA
Comparison: Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.440395% CI: [-0.53, 0.23]ANCOVA
Comparison: Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.320595% CI: [-0.58, 0.19]ANCOVA
Comparison: Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.576395% CI: [-0.51, 0.28]ANCOVA
Comparison: Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.288795% CI: [-0.61, 0.18]ANCOVA
Secondary
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16
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.
Time frame: Baseline, Week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 | -2.98 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 | -3.08 units on a scale | Standard Error 0.14 |
| Tramadol | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 | -2.81 units on a scale | Standard Error 0.12 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.311895% CI: [-0.5, 0.16]ANCOVA
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.p-value: 0.095895% CI: [-0.6, 0.05]ANCOVA
Secondary
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 12.2 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 9.1 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 10.5 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | SBP: Baseline | 123.8 millimeters of mercury (mmHg) | Standard Deviation 13.25 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | DBP: Baseline | 78.6 millimeters of mercury (mmHg) | Standard Deviation 8.98 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 11.46 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 11.05 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -1.5 millimeters of mercury (mmHg) | Standard Deviation 7.75 |
| Pooled Tanezumab 5 mg | 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 7.8 |
| Pooled Tanezumab 5 mg | 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 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 8.04 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 8.21 |
| Pooled Tanezumab 5 mg | 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 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 11.38 |
| Pooled Tanezumab 5 mg | 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 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 10.75 |
| Pooled Tanezumab 5 mg | 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 | -1.1 millimeters of mercury (mmHg) | Standard Deviation 7.49 |
| Pooled Tanezumab 10 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | DBP: Baseline | 77.4 millimeters of mercury (mmHg) | Standard Deviation 8.48 |
| Pooled Tanezumab 10 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | SBP: Baseline | 122.6 millimeters of mercury (mmHg) | Standard Deviation 12.36 |
| Pooled Tanezumab 10 mg | 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 | -1.4 millimeters of mercury (mmHg) | Standard Deviation 10.62 |
| Pooled Tanezumab 10 mg | 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 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 10.65 |
| Pooled Tanezumab 10 mg | 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 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 11.02 |
| Pooled Tanezumab 10 mg | 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 | -1.4 millimeters of mercury (mmHg) | Standard Deviation 11.1 |
| Pooled Tanezumab 10 mg | 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 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 11.53 |
| Pooled Tanezumab 10 mg | 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 | -1.4 millimeters of mercury (mmHg) | Standard Deviation 11.53 |
| Pooled Tanezumab 10 mg | 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 | -1.6 millimeters of mercury (mmHg) | Standard Deviation 11.91 |
| Pooled Tanezumab 10 mg | 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 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 11.51 |
| Pooled Tanezumab 10 mg | 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 | -1.5 millimeters of mercury (mmHg) | Standard Deviation 7.91 |
| Pooled Tanezumab 10 mg | 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 | -1.1 millimeters of mercury (mmHg) | Standard Deviation 7.59 |
| Pooled Tanezumab 10 mg | 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 | -1.5 millimeters of mercury (mmHg) | Standard Deviation 8.26 |
| Pooled Tanezumab 10 mg | 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 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 8.39 |
| Pooled Tanezumab 10 mg | 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 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 8.13 |
| Pooled Tanezumab 10 mg | 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 | -0.5 millimeters of mercury (mmHg) | Standard Deviation 8.1 |
| Pooled Tanezumab 10 mg | 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 | -1.1 millimeters of mercury (mmHg) | Standard Deviation 8.13 |
| Pooled Tanezumab 10 mg | 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 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 8.23 |
| Pooled Tanezumab 10 mg | 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 8.05 |
| Pooled Tanezumab 10 mg | 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 | -0.0 millimeters of mercury (mmHg) | Standard Deviation 9.13 |
| Pooled Tanezumab 10 mg | 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 | 0.5 millimeters of mercury (mmHg) | Standard Deviation 9.07 |
| Pooled Tanezumab 10 mg | 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 | -3.0 millimeters of mercury (mmHg) | Standard Deviation 12.03 |
| Pooled Tanezumab 10 mg | 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 | -1.9 millimeters of mercury (mmHg) | Standard Deviation 12.28 |
| Pooled Tanezumab 10 mg | 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 | 0.1 millimeters of mercury (mmHg) | Standard Deviation 12.62 |
| Tramadol | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | DBP: Baseline | 78.2 millimeters of mercury (mmHg) | Standard Deviation 9.01 |
| Tramadol | 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 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 11.59 |
| Tramadol | 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 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 7.93 |
| Tramadol | 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 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 12.46 |
| Tramadol | 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 | -1.6 millimeters of mercury (mmHg) | Standard Deviation 11.96 |
| Tramadol | 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 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 7.75 |
| Tramadol | 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 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 11.99 |
| Tramadol | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | SBP: Baseline | 123.7 millimeters of mercury (mmHg) | Standard Deviation 13.77 |
| Tramadol | 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 | -0.6 millimeters of mercury (mmHg) | Standard Deviation 8.95 |
| Tramadol | 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 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 12.54 |
| Tramadol | 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 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 11.77 |
| Tramadol | 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 | -0.1 millimeters of mercury (mmHg) | Standard Deviation 8.55 |
| Tramadol | 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 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 11.99 |
| Tramadol | 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 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 11.81 |
| Tramadol | 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 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 8.15 |
| Tramadol | 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 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 8.13 |
| Tramadol | 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 | -1.1 millimeters of mercury (mmHg) | Standard Deviation 12.03 |
| Tramadol | 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 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 7.76 |
| Tramadol | 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 | -0.9 millimeters of mercury (mmHg) | Standard Deviation 7.94 |
| Tramadol | 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 | -1.9 millimeters of mercury (mmHg) | Standard Deviation 12.67 |
| Tramadol | 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 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 8.39 |
| Tramadol | 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 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 8.21 |
| Tramadol | 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 | -1.4 millimeters of mercury (mmHg) | Standard Deviation 11.37 |
| Tramadol | 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 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 8.36 |
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data
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.
Time frame: Baseline, Week 64
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'number analyzed' = participants evaluable for this OM at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 1.2 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Change at Week 64 | -4.09 units on a scale | Standard Deviation 1.82 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Baseline | 7.02 units on a scale | Standard Deviation 1.15 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Baseline | 7.00 units on a scale | Standard Deviation 1.18 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Change at Week 64 | -3.84 units on a scale | Standard Deviation 2.23 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Baseline | 6.88 units on a scale | Standard Deviation 1.21 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Change at Week 64 | -3.39 units on a scale | Standard Deviation 2.38 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Change at Week 64 | -4.04 units on a scale | Standard Deviation 2.06 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Baseline | 6.97 units on a scale | Standard Deviation 1.21 |
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data
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.
Time frame: Baseline, Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 1.9 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Change at Week 64 | -4.21 units on a scale | Standard Deviation 1.98 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Baseline | 6.20 units on a scale | Standard Deviation 1.88 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Change at Week 64 | -4.00 units on a scale | Standard Deviation 2.44 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Baseline | 6.28 units on a scale | Standard Deviation 1.81 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Baseline | 6.16 units on a scale | Standard Deviation 1.93 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Change at Week 64 | -3.60 units on a scale | Standard Deviation 2.3 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Change at Week 64 | -3.98 units on a scale | Standard Deviation 2.1 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Baseline | 6.21 units on a scale | Standard Deviation 1.88 |
Secondary
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
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.50 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | 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 | -3.06 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 5 mg | 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 | -2.70 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -1.88 units on a scale | Standard Error 0.11 |
| Pooled Tanezumab 10 mg | 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 | -2.75 units on a scale | Standard Error 0.16 |
| Pooled Tanezumab 10 mg | 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 | -2.83 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 10 mg | 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 | -2.48 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -3.23 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | 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 | -2.44 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -2.68 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -1.97 units on a scale | Standard Error 0.11 |
| Tramadol | 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 | -2.21 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -1.57 units on a scale | Standard Error 0.1 |
| Tramadol | 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 | -2.14 units on a scale | Standard Error 0.11 |
| Tramadol | 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 | -2.44 units on a scale | Standard Error 0.11 |
| Tramadol | 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 | -2.80 units on a scale | Standard Error 0.12 |
| Tramadol | 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 | -2.44 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.37 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.24 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.18 units on a scale | Standard Error 0.14 |
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001395% CI: [-0.77, -0.19]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000195% CI: [-0.87, -0.28]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.227295% CI: [-0.43, -0.1]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.020995% CI: [-0.58, -0.05]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.002995% CI: [-0.67, -0.14]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000295% CI: [-0.92, -0.28]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.1, -0.46]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.119895% CI: [-0.53, 0.06]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.01695% CI: [-0.66, -0.07]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000395% CI: [-0.85, -0.25]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.009195% CI: [-0.77, -0.11]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000795% CI: [-0.9, -0.24]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.226495% CI: [-0.48, 0.11]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.096195% CI: [-0.56, 0.05]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.012195% CI: [-0.69, -0.08]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.02795% CI: [-0.77, -0.05]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001995% CI: [-0.94, -0.21]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.390695% CI: [-0.48, 0.19]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.120995% CI: [-0.59, 0.07]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.010795% CI: [-0.76, -0.1]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.239695% CI: [-0.61, 0.15]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.108895% CI: [-0.69, 0.07]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.167395% CI: [-0.65, 0.11]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.175195% CI: [-0.66, 0.12]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.316495% CI: [-0.59, 0.19]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.225395% CI: [-0.62, 0.15]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.340895% CI: [-0.58, 0.2]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.339195% CI: [-0.58, 0.2]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.581895% CI: [-0.5, 0.28]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.256295% CI: [-0.62, 0.16]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data
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.
Time frame: Baseline, Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 | -4.46 units on a scale | Standard Deviation 2.19 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data | Baseline | 6.69 units on a scale | Standard Deviation 1.75 |
| Pooled Tanezumab 10 mg | 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 | -4.03 units on a scale | Standard Deviation 2.74 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data | Baseline | 6.69 units on a scale | Standard Deviation 1.7 |
| Tramadol | 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 | -3.72 units on a scale | Standard Deviation 2.57 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data | Baseline | 6.66 units on a scale | Standard Deviation 1.82 |
| Tramadol | 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 | -4.16 units on a scale | Standard Deviation 2.33 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data | Baseline | 6.67 units on a scale | Standard Deviation 1.75 |
Secondary
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
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.68 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 5 mg | 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 | -1.84 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.45 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -3.20 units on a scale | Standard Error 0.15 |
| Pooled Tanezumab 10 mg | 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 | -1.91 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | 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 | -2.76 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.53 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 | -2.71 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 10 mg | 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 | -2.86 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | 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 | -3.35 units on a scale | Standard Error 0.15 |
| Pooled Tanezumab 10 mg | 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 | -2.87 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.58 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 |
| Tramadol | 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 | -2.52 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.54 units on a scale | Standard Error 0.12 |
| Tramadol | 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 | -1.53 units on a scale | Standard Error 0.1 |
| Tramadol | 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 | -2.40 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.14 units on a scale | Standard Error 0.12 |
| Tramadol | 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 | -2.39 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.33 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.60 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.89 units on a scale | Standard Error 0.13 |
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.013795% CI: [-0.69, -0.08]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.004495% CI: [-0.76, -0.14]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.619495% CI: [-0.35, 0.21]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.027195% CI: [-0.59, -0.04]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.008595% CI: [-0.66, -0.1]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.002795% CI: [-0.87, -0.18]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.13, -0.44]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.185995% CI: [-0.54, 0.1]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.057395% CI: [-0.63, 0.01]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000595% CI: [-0.88, -0.25]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.084195% CI: [-0.66, 0.04]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.007495% CI: [-0.85, -0.13]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.31695% CI: [-0.49, 0.16]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.376395% CI: [-0.47, 0.18]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.050595% CI: [-0.65, 0]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.011895% CI: [-0.88, -0.11]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001295% CI: [-1.03, -0.25]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.296695% CI: [-0.54, 0.17]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.095695% CI: [-0.66, 0.05]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.011795% CI: [-0.81, -0.1]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.373295% CI: [-0.57, 0.21]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.192295% CI: [-0.66, 0.13]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.298695% CI: [-0.63, 0.19]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.258495% CI: [-0.65, 0.17]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.519595% CI: [-0.57, 0.29]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.375295% CI: [-0.6, 0.22]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.515795% CI: [-0.56, 0.28]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.506595% CI: [-0.56, 0.28]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.837395% CI: [-0.47, 0.38]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.514695% CI: [-0.56, 0.28]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data
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.
Time frame: Baseline, Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data | Baseline | 6.62 units on a scale | Standard Deviation 2.03 |
| Pooled Tanezumab 5 mg | 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 | -4.60 units on a scale | Standard Deviation 2.46 |
| Pooled Tanezumab 10 mg | 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 | -4.15 units on a scale | Standard Deviation 2.86 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data | Baseline | 6.65 units on a scale | Standard Deviation 1.91 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data | Baseline | 6.65 units on a scale | Standard Deviation 1.9 |
| Tramadol | 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 | -3.80 units on a scale | Standard Deviation 2.71 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data | Baseline | 6.56 units on a scale | Standard Deviation 2.07 |
| Tramadol | 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 | -4.08 units on a scale | Standard Deviation 2.39 |
Secondary
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
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 | -1.86 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 5 mg | 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 | -2.70 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 5 mg | 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 | -2.43 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 5 mg | 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 | -3.15 units on a scale | Standard Error 0.15 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -2.81 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | 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 | -2.01 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | 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 | -2.96 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | 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 | -3.33 units on a scale | Standard Error 0.16 |
| Pooled Tanezumab 10 mg | 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 | -2.58 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 | -2.49 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 | -2.75 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 | -2.89 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.60 units on a scale | Standard Error 0.18 |
| Tramadol | 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 | -2.87 units on a scale | Standard Error 0.13 |
| Tramadol | 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 | -2.14 units on a scale | Standard Error 0.12 |
| Tramadol | 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 | -2.33 units on a scale | Standard Error 0.16 |
| Tramadol | 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 | -1.53 units on a scale | Standard Error 0.1 |
| Tramadol | 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 | -2.51 units on a scale | Standard Error 0.12 |
| Tramadol | 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 | -2.37 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.53 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.52 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.33 units on a scale | Standard Error 0.15 |
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000795% CI: [-0.88, -0.24]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.03, -0.38]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.129195% CI: [-0.53, 0.07]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.02995% CI: [-0.63, -0.03]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001595% CI: [-0.77, -0.18]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.004195% CI: [-0.87, -0.17]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.25, -0.54]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.179995% CI: [-0.55, 0.1]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.069695% CI: [-0.62, 0.02]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.99, -0.35]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.038795% CI: [-0.74, -0.02]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000595% CI: [-1, -0.28]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.276895% CI: [-0.51, 0.15]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.240895% CI: [-0.53, 0.13]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.006495% CI: [-0.78, -0.13]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.011595% CI: [-0.9, -0.11]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000695% CI: [-1.08, -0.29]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.202895% CI: [-0.59, 0.13]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.135195% CI: [-0.64, 0.09]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.013395% CI: [-0.82, -0.09]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.215795% CI: [-0.65, 0.15]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.078195% CI: [-0.76, 0.04]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.352795% CI: [-0.62, 0.22]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.299495% CI: [-0.65, 0.2]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.332695% CI: [-0.63, 0.21]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.282295% CI: [-0.65, 0.19]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.493295% CI: [-0.57, 0.28]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.457195% CI: [-0.58, 0.26]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.558695% CI: [-0.56, 0.3]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.266495% CI: [-0.67, 0.19]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data
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.
Time frame: Baseline, Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 | -4.54 units on a scale | Standard Deviation 2.8 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data | Baseline | 6.73 units on a scale | Standard Deviation 2.37 |
| Pooled Tanezumab 10 mg | 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 | -4.19 units on a scale | Standard Deviation 2.95 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data | Baseline | 6.88 units on a scale | Standard Deviation 2.31 |
| Tramadol | 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 | -4.05 units on a scale | Standard Deviation 2.7 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data | Baseline | 6.67 units on a scale | Standard Deviation 2.39 |
| Tramadol | 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 | -4.11 units on a scale | Standard Deviation 2.78 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data | Baseline | 6.82 units on a scale | Standard Deviation 2.38 |
Secondary
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
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.09 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.79 units on a scale | Standard Error 0.15 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.94 units on a scale | Standard Error 0.15 |
| Pooled Tanezumab 5 mg | 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 | -3.38 units on a scale | Standard Error 0.16 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -2.98 units on a scale | Standard Error 0.15 |
| Pooled Tanezumab 10 mg | 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 | -2.15 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | 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 | -3.13 units on a scale | Standard Error 0.15 |
| Pooled Tanezumab 10 mg | 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 | -3.44 units on a scale | Standard Error 0.16 |
| Pooled Tanezumab 10 mg | 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 | -3.09 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 | -2.94 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 | -2.81 units on a scale | Standard Error 0.19 |
| Pooled Tanezumab 10 mg | 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 | -2.73 units on a scale | Standard Error 0.19 |
| Pooled Tanezumab 10 mg | 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 | -2.74 units on a scale | Standard Error 0.18 |
| Tramadol | 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 | -2.54 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -1.80 units on a scale | Standard Error 0.11 |
| Tramadol | 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 | -2.59 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.70 units on a scale | Standard Error 0.13 |
| Tramadol | 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 | -2.41 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -3.00 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.34 units on a scale | Standard Error 0.13 |
| Tramadol | 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 | -2.37 units on a scale | Standard Error 0.16 |
| Tramadol | 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 | -2.34 units on a scale | Standard Error 0.16 |
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.003795% CI: [-0.85, -0.17]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001395% CI: [-0.91, -0.22]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.171295% CI: [-0.53, 0.09]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.068695% CI: [-0.6, 0.02]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.028995% CI: [-0.66, -0.04]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000395% CI: [-1.02, -0.3]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.22, -0.49]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.205695% CI: [-0.55, 0.12]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.008495% CI: [-0.78, -0.11]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000295% CI: [-0.98, -0.31]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.006395% CI: [-0.9, -0.15]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000295% CI: [-1.09, -0.34]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.115595% CI: [-0.63, 0.07]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.165295% CI: [-0.59, 0.1]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.012995% CI: [-0.78, -0.09]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.023695% CI: [-0.87, -0.06]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.013695% CI: [-0.93, -0.11]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.662495% CI: [-0.47, 0.3]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.046895% CI: [-0.75, -0.01]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.02595% CI: [-0.81, -0.05]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.153995% CI: [-0.72, 0.11]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.016995% CI: [-0.91, -0.09]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.104995% CI: [-0.77, 0.07]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.059995% CI: [-0.82, 0.02]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.304195% CI: [-0.65, 0.2]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.073795% CI: [-0.83, 0.04]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.229395% CI: [-0.71, 0.17]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.080695% CI: [-0.82, 0.05]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.36895% CI: [-0.62, 0.23]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.089395% CI: [-0.79, 0.06]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data
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.
Time frame: Baseline, Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 | -4.14 units on a scale | Standard Deviation 2.37 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data | Baseline | 6.07 units on a scale | Standard Deviation 2.14 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data | Baseline | 5.95 units on a scale | Standard Deviation 2.22 |
| Pooled Tanezumab 10 mg | 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 | -3.65 units on a scale | Standard Deviation 2.79 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data | Baseline | 6.01 units on a scale | Standard Deviation 2.24 |
| Tramadol | 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 | -3.61 units on a scale | Standard Deviation 2.65 |
| Tramadol | 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 2.37 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data | Baseline | 6.04 units on a scale | Standard Deviation 2.03 |
Secondary
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
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.60 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -1.72 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 5 mg | 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 | -2.38 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | 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 | -2.90 units on a scale | Standard Error 0.15 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -2.55 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 10 mg | 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 | -2.73 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 10 mg | 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 | -2.46 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.73 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.45 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.59 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -1.89 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | 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 | -2.34 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -3.15 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.07 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.04 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.03 units on a scale | Standard Error 0.12 |
| Tramadol | 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 | -2.30 units on a scale | Standard Error 0.11 |
| Tramadol | 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 | -2.68 units on a scale | Standard Error 0.13 |
| Tramadol | 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 | -2.30 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.24 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.09 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -1.54 units on a scale | Standard Error 0.1 |
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.005995% CI: [-0.76, -0.13]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000295% CI: [-0.93, -0.29]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.075695% CI: [-0.56, 0.03]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.219795% CI: [-0.47, 0.11]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.020895% CI: [-0.63, -0.05]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001395% CI: [-0.91, -0.22]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.08, -0.39]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.187395% CI: [-0.53, 0.1]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.030595% CI: [-0.66, -0.03]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001395% CI: [-0.84, -0.2]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.015895% CI: [-0.78, -0.08]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001595% CI: [-0.91, -0.21]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.417395% CI: [-0.45, 0.19]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.065995% CI: [-0.62, 0.02]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.007895% CI: [-0.74, -0.11]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.073795% CI: [-0.72, 0.03]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.002195% CI: [-0.97, -0.22]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.453595% CI: [-0.48, 0.21]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.227195% CI: [-0.56, 0.13]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.008695% CI: [-0.81, -0.12]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.224395% CI: [-0.63, 0.15]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.033195% CI: [-0.81, -0.03]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.183895% CI: [-0.66, 0.13]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.079595% CI: [-0.75, 0.04]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.284795% CI: [-0.63, 0.18]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.074595% CI: [-0.76, 0.04]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.31195% CI: [-0.59, 0.19]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.137595% CI: [-0.7, 0.1]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.403695% CI: [-0.58, 0.23]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.064195% CI: [-0.79, 0.02]ANCOVA
Secondary
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
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 0.1 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 | -1.40 units on a scale | Standard Error 0.1 |
| Pooled Tanezumab 5 mg | 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 | -2.84 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.04 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.36 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -2.60 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | 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 | -2.93 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | 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 | -1.47 units on a scale | Standard Error 0.1 |
| Pooled Tanezumab 10 mg | 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 | -2.22 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | 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 | -2.72 units on a scale | Standard Error 0.16 |
| Pooled Tanezumab 10 mg | 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 | -2.67 units on a scale | Standard Error 0.16 |
| Pooled Tanezumab 10 mg | 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 | -2.53 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.44 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -2.51 units on a scale | Standard Error 0.17 |
| Tramadol | 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 | -2.29 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.43 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.32 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.29 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.20 units on a scale | Standard Error 0.1 |
| Tramadol | 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 | -2.64 units on a scale | Standard Error 0.12 |
| Tramadol | 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 | -1.76 units on a scale | Standard Error 0.1 |
| Tramadol | 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 | -2.45 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -1.20 units on a scale | Standard Error 0.08 |
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000295% CI: [-0.72, -0.22]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.79, -0.29]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.019395% CI: [-0.5, -0.04]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.084595% CI: [-0.42, 0.03]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.021295% CI: [-0.49, -0.04]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000395% CI: [-0.81, -0.24]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.99, -0.41]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.07995% CI: [-0.5, 0.03]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.033695% CI: [-0.55, -0.02]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000895% CI: [-0.73, -0.19]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.003495% CI: [-0.77, -0.15]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.01, -0.39]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.036195% CI: [-0.59, -0.02]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.278695% CI: [-0.44, 0.13]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.005895% CI: [-0.68, -0.11]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.036595% CI: [-0.71, -0.02]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.009295% CI: [-0.8, -0.11]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.292395% CI: [-0.49, 0.15]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.223195% CI: [-0.51, 0.12]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.072495% CI: [-0.6, 0.03]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.477695% CI: [-0.5, 0.23]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.148295% CI: [-0.64, 0.1]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.324995% CI: [-0.56, 0.18]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.199795% CI: [-0.62, 0.13]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.482395% CI: [-0.53, 0.25]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.275495% CI: [-0.6, 0.17]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.586195% CI: [-0.5, 0.29]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.434695% CI: [-0.54, 0.23]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.875295% CI: [-0.42, 0.36]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.266395% CI: [-0.6, 0.17]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data
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.
Time frame: Baseline, Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Baseline | 7.91 units on a scale | Standard Deviation 1.09 |
| Pooled Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Change at Week 64 | -4.28 units on a scale | Standard Deviation 2.37 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Change at Week 64 | -4.01 units on a scale | Standard Deviation 2.68 |
| Pooled Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Baseline | 7.95 units on a scale | Standard Deviation 1.11 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Baseline | 7.92 units on a scale | Standard Deviation 1.19 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Change at Week 64 | -3.61 units on a scale | Standard Deviation 2.52 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Change at Week 64 | -4.23 units on a scale | Standard Deviation 2.39 |
| Tramadol | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Baseline | 7.92 units on a scale | Standard Deviation 1.18 |
Secondary
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
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 0.1 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.57 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | 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 | -1.66 units on a scale | Standard Error 0.1 |
| Pooled Tanezumab 5 mg | 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 | -3.18 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -2.30 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -2.95 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -3.21 units on a scale | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | 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 | -2.78 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 | -2.74 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 | -2.73 units on a scale | Standard Error 0.18 |
| Pooled Tanezumab 10 mg | 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 | -2.50 units on a scale | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | 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 | -2.86 units on a scale | Standard Error 0.13 |
| Pooled Tanezumab 10 mg | 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 | -3.01 units on a scale | Standard Error 0.17 |
| Pooled Tanezumab 10 mg | 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 | -1.76 units on a scale | Standard Error 0.1 |
| Tramadol | 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 | -2.45 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -1.40 units on a scale | Standard Error 0.09 |
| Tramadol | 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 | -1.98 units on a scale | Standard Error 0.11 |
| Tramadol | 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 | -2.37 units on a scale | Standard Error 0.11 |
| Tramadol | 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 | -2.90 units on a scale | Standard Error 0.12 |
| Tramadol | 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 | -2.66 units on a scale | Standard Error 0.14 |
| Tramadol | 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 | -2.63 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.51 units on a scale | Standard Error 0.15 |
| Tramadol | 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 | -2.44 units on a scale | Standard Error 0.15 |
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000395% CI: [-0.75, -0.22]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.85, -0.33]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.061595% CI: [-0.47, 0.01]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.035695% CI: [-0.5, -0.02]ANCOVA
Comparison: Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.003295% CI: [-0.6, -0.12]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000395% CI: [-0.88, -0.27]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.08, -0.46]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.084495% CI: [-0.54, 0.03]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.025895% CI: [-0.6, -0.04]ANCOVA
Comparison: Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000495% CI: [-0.8, -0.23]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.007995% CI: [-0.78, -0.12]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.08, -0.41]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.097795% CI: [-0.57, 0.05]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.21595% CI: [-0.5, 0.11]ANCOVA
Comparison: Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001695% CI: [-0.79, -0.18]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.005895% CI: [-0.88, -0.15]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.003895% CI: [-0.91, -0.18]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.170795% CI: [-0.58, 0.1]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.108395% CI: [-0.62, 0.06]ANCOVA
Comparison: Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.073495% CI: [-0.64, 0.03]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.460395% CI: [-0.56, 0.25]ANCOVA
Comparison: Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.079995% CI: [-0.74, 0.04]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.233995% CI: [-0.66, 0.16]ANCOVA
Comparison: Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.119995% CI: [-0.73, 0.08]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.38495% CI: [-0.6, 0.23]ANCOVA
Comparison: Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.295% CI: [-0.68, 0.14]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.299795% CI: [-0.65, 0.2]ANCOVA
Comparison: Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.177895% CI: [-0.71, 0.13]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.343895% CI: [-0.65, 0.23]ANCOVA
Comparison: Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.187695% CI: [-0.71, 0.14]ANCOVA
Secondary
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64
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.
Time frame: Baseline, Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Change at Week 64 | -4.32 units on a scale | Standard Deviation 2.01 |
| Pooled Tanezumab 5 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Baseline | 7.23 units on a scale | Standard Deviation 1.09 |
| Pooled Tanezumab 10 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Change at Week 64 | -4.04 units on a scale | Standard Deviation 2.15 |
| Pooled Tanezumab 10 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Baseline | 7.25 units on a scale | Standard Deviation 1.08 |
| Tramadol | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Baseline | 7.18 units on a scale | Standard Deviation 1.13 |
| Tramadol | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Change at Week 64 | -3.71 units on a scale | Standard Deviation 2.39 |
| Tramadol | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Change at Week 64 | -4.08 units on a scale | Standard Deviation 2.12 |
| Tramadol | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Baseline | 7.17 units on a scale | Standard Deviation 1.16 |
Secondary
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
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.
Time frame: Baseline, Weeks 16, 56 and 80
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval: Baseline | 90.9 millisecond | Standard Deviation 8.72 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval: Baseline | 156.2 millisecond | Standard Deviation 20.51 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval: Baseline | 928.5 millisecond | Standard Deviation 150.4 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval:Change at Week 16 | 411.8 millisecond | Standard Deviation 17.5 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval: Baseline | 411.7 millisecond | Standard Deviation 20.49 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval: Baseline | 405.6 millisecond | Standard Deviation 18.22 |
| Placebo | 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 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval: Baseline | 394.7 millisecond | Standard Deviation 29.67 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval: Baseline | 911.4 millisecond | Standard Deviation 140.72 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval:Change at Week 16 | 897.1 millisecond | Standard Deviation 129.55 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval:Change at Week 16 | 158.3 millisecond | Standard Deviation 21.99 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval: Baseline | 92.5 millisecond | Standard Deviation 11.06 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval:Change at Week 16 | 93.4 millisecond | Standard Deviation 11.95 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval: Baseline | 393.1 millisecond | Standard Deviation 29.52 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval:Change at Week 16 | 391.1 millisecond | Standard Deviation 28.13 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval: Baseline | 413.5 millisecond | Standard Deviation 20.19 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval:Change at Week 16 | 414.5 millisecond | Standard Deviation 19.76 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval: Baseline | 406.3 millisecond | Standard Deviation 18.85 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval:Change at Week 16 | 406.3 millisecond | Standard Deviation 18.45 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval:Change at Week 80 | 405.7 millisecond | Standard Deviation 17.7 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval: Baseline | 157.3 millisecond | Standard Deviation 23.32 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval:Change at Week 56 | 408.9 millisecond | Standard Deviation 19.75 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval:Change at Week 80 | 95.0 millisecond | Standard Deviation 12.53 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval: Baseline | 407.4 millisecond | Standard Deviation 18.93 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval: Baseline | 394.6 millisecond | Standard Deviation 27.54 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval:Change at Week 56 | 893.0 millisecond | Standard Deviation 144.3 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval:Change at Week 16 | 393.5 millisecond | Standard Deviation 29.09 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval: Baseline | 915.4 millisecond | Standard Deviation 138.41 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval:Change at Week 56 | 392.8 millisecond | Standard Deviation 29.47 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval:Change at Week 80 | 393.0 millisecond | Standard Deviation 29.9 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval:Change at Week 16 | 406.7 millisecond | Standard Deviation 20.35 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval: Baseline | 414.4 millisecond | Standard Deviation 21.6 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval:Change at Week 16 | 912.1 millisecond | Standard Deviation 142.81 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval:Change at Week 16 | 413.9 millisecond | Standard Deviation 22.67 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval:Change at Week 80 | 409.7 millisecond | Standard Deviation 19.74 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval:Change at Week 56 | 417.7 millisecond | Standard Deviation 22.02 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval:Change at Week 16 | 159.6 millisecond | Standard Deviation 21.84 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval: Baseline | 158.1 millisecond | Standard Deviation 22.93 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval:Change at Week 56 | 158.1 millisecond | Standard Deviation 20.85 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval:Change at Week 80 | 157.7 millisecond | Standard Deviation 21.6 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval:Change at Week 80 | 418.8 millisecond | Standard Deviation 22.13 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval: Baseline | 93.5 millisecond | Standard Deviation 12.3 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval:Change at Week 80 | 889.6 millisecond | Standard Deviation 143.1 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval:Change at Week 16 | 94.5 millisecond | Standard Deviation 13.27 |
| Pooled Tanezumab 10 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval:Change at Week 56 | 95.4 millisecond | Standard Deviation 12.62 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval:Change at Week 16 | 93.9 millisecond | Standard Deviation 12.53 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval:Change at Week 56 | 407.3 millisecond | Standard Deviation 19.74 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval:Change at Week 16 | 415.3 millisecond | Standard Deviation 20.13 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval:Change at Week 80 | 94.4 millisecond | Standard Deviation 13.16 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval:Change at Week 56 | 881.5 millisecond | Standard Deviation 136.11 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval:Change at Week 80 | 158.3 millisecond | Standard Deviation 21.46 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval:Change at Week 80 | 876.5 millisecond | Standard Deviation 134.79 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval: Baseline | 393.7 millisecond | Standard Deviation 29.06 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval: Baseline | 157.8 millisecond | Standard Deviation 23.44 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval: Baseline | 405.9 millisecond | Standard Deviation 20.28 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval:Change at Week 56 | 416.8 millisecond | Standard Deviation 21.71 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval:Change at Week 16 | 391.2 millisecond | Standard Deviation 30.3 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval:Change at Week 80 | 417.0 millisecond | Standard Deviation 21.71 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval:Change at Week 16 | 158.6 millisecond | Standard Deviation 23.37 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval:Change at Week 56 | 389.7 millisecond | Standard Deviation 29.44 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval:Change at Week 80 | 407.1 millisecond | Standard Deviation 19.81 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval: Baseline | 918.9 millisecond | Standard Deviation 138.55 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QT Interval:Change at Week 80 | 388.7 millisecond | Standard Deviation 29.33 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | RR Interval:Change at Week 16 | 894.9 millisecond | Standard Deviation 139.62 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval: Baseline | 93.1 millisecond | Standard Deviation 12.02 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | PR Interval:Change at Week 56 | 159.2 millisecond | Standard Deviation 22.13 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCB Interval: Baseline | 412.6 millisecond | Standard Deviation 22.39 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QRS Interval:Change at Week 56 | 94.2 millisecond | Standard Deviation 13.73 |
| Tramadol | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 | QTCF Interval:Change at Week 16 | 406.8 millisecond | Standard Deviation 19.04 |
Secondary
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80
Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Time frame: Baseline, Weeks 16, 56 and 80
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Change at Week 16 | 68.3 beats per minute | Standard Deviation 10 |
| Pooled Tanezumab 5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Baseline | 67.4 beats per minute | Standard Deviation 10.34 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Change at Week 56 | 68.9 beats per minute | Standard Deviation 11.02 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Change at Week 16 | 67.4 beats per minute | Standard Deviation 10.35 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Baseline | 67.1 beats per minute | Standard Deviation 10.31 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Change at Week 80 | 69.3 beats per minute | Standard Deviation 11.61 |
| Tramadol | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Change at Week 16 | 68.8 beats per minute | Standard Deviation 10.99 |
| Tramadol | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Baseline | 66.9 beats per minute | Standard Deviation 10.64 |
| Tramadol | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Change at Week 80 | 70.1 beats per minute | Standard Deviation 10.98 |
| Tramadol | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 | Change at Week 56 | 69.7 beats per minute | Standard Deviation 11.26 |
Secondary
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 16 | -0.6 beats per minute | Standard Deviation 9.99 |
| Pooled Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 4 | 0.6 beats per minute | Standard Deviation 8.82 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 73.1 beats per minute | Standard Deviation 10.23 |
| Pooled Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 2 | 0.5 beats per minute | Standard Deviation 9.09 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 8 | 0.1 beats per minute | Standard Deviation 9.41 |
| Pooled Tanezumab 10 mg | 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 10.79 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 4 | 0.4 beats per minute | Standard Deviation 9.47 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 8 | -0.1 beats per minute | Standard Deviation 9.87 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 16 | -1.0 beats per minute | Standard Deviation 9.65 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 24 | -0.3 beats per minute | Standard Deviation 9.77 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 56 | 0.2 beats per minute | Standard Deviation 10.5 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 64 | 0.8 beats per minute | Standard Deviation 10.08 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 80 | 1.2 beats per minute | Standard Deviation 9.83 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 72.5 beats per minute | Standard Deviation 10.1 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 2 | 0.3 beats per minute | Standard Deviation 9.23 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 32 | -0.3 beats per minute | Standard Deviation 9.94 |
| Pooled Tanezumab 10 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 40 | -0.5 beats per minute | Standard Deviation 9.77 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 56 | 0.7 beats per minute | Standard Deviation 11.1 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 48 | 0.9 beats per minute | Standard Deviation 10.33 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 40 | 1.3 beats per minute | Standard Deviation 9.55 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 2 | -0.2 beats per minute | Standard Deviation 9.24 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 24 | 0.2 beats per minute | Standard Deviation 10.09 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 8 | 0.0 beats per minute | Standard Deviation 9.89 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 32 | 0.6 beats per minute | Standard Deviation 9.72 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 64 | 0.7 beats per minute | Standard Deviation 10.22 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 16 | -0.8 beats per minute | Standard Deviation 10.13 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 80 | 0.9 beats per minute | Standard Deviation 11.48 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 4 | 0.2 beats per minute | Standard Deviation 9.57 |
| Tramadol | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 73.2 beats per minute | Standard Deviation 10.61 |
Secondary
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 1.6 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -0.06 units on a scale | Standard Deviation 1.37 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -0.09 units on a scale | Standard Deviation 1.41 |
| Pooled Tanezumab 5 mg | 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 | -0.02 units on a scale | Standard Deviation 0.96 |
| Pooled Tanezumab 5 mg | 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 | 0.05 units on a scale | Standard Deviation 1.12 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 0.58 units on a scale | Standard Deviation 2.28 |
| Pooled Tanezumab 10 mg | 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 | -0.10 units on a scale | Standard Deviation 1.85 |
| Pooled Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 0.86 units on a scale | Standard Deviation 2.54 |
| Pooled Tanezumab 10 mg | 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 | -0.08 units on a scale | Standard Deviation 1.34 |
| Pooled Tanezumab 10 mg | 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 | -0.17 units on a scale | Standard Deviation 1.57 |
| Pooled Tanezumab 10 mg | 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 | -0.17 units on a scale | Standard Deviation 1.99 |
| Pooled Tanezumab 10 mg | 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 | -0.06 units on a scale | Standard Deviation 1.94 |
| Pooled Tanezumab 10 mg | 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 | -0.09 units on a scale | Standard Deviation 1.77 |
| Pooled Tanezumab 10 mg | 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 | -0.12 units on a scale | Standard Deviation 1.73 |
| Pooled Tanezumab 10 mg | 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 1.81 |
| Pooled Tanezumab 10 mg | 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 | -0.09 units on a scale | Standard Deviation 2.07 |
| Pooled Tanezumab 10 mg | 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 | -0.09 units on a scale | Standard Deviation 2.06 |
| Pooled Tanezumab 10 mg | 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 | -0.12 units on a scale | Standard Deviation 2.15 |
| Tramadol | 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 1.84 |
| Tramadol | 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 | 0.08 units on a scale | Standard Deviation 3.53 |
| Tramadol | 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 | 0.00 units on a scale | Standard Deviation 1.92 |
| Tramadol | 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 | -0.16 units on a scale | Standard Deviation 1.36 |
| Tramadol | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 0.78 units on a scale | Standard Deviation 2.62 |
| Tramadol | 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 | -0.03 units on a scale | Standard Deviation 1.97 |
| Tramadol | 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 | -0.15 units on a scale | Standard Deviation 1.31 |
| Tramadol | 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 | -0.07 units on a scale | Standard Deviation 2.06 |
| Tramadol | 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 | 0.03 units on a scale | Standard Deviation 1.9 |
| Tramadol | 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 | 0.03 units on a scale | Standard Deviation 2.32 |
| Tramadol | 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 | -0.06 units on a scale | Standard Deviation 2.03 |
| Tramadol | 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 | -0.02 units on a scale | Standard Deviation 1.97 |
Secondary
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data
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.
Time frame: Baseline, Week 64
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'Number analyzed' = participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Change at Week 64 | -1.16 units on a scale | Standard Deviation 0.86 |
| Pooled Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Baseline | 3.49 units on a scale | Standard Deviation 0.6 |
| Pooled Tanezumab 10 mg | 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 0.61 |
| Pooled Tanezumab 10 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Change at Week 64 | -1.03 units on a scale | Standard Deviation 0.98 |
| Tramadol | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Change at Week 64 | -1.01 units on a scale | Standard Deviation 0.92 |
| Tramadol | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Baseline | 3.53 units on a scale | Standard Deviation 0.63 |
| Tramadol | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Baseline | 3.50 units on a scale | Standard Deviation 0.63 |
| Tramadol | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Change at Week 64 | -1.14 units on a scale | Standard Deviation 0.88 |
Secondary
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
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -0.98 units on a scale | Standard Error 0.05 |
| Pooled Tanezumab 5 mg | 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 | -0.82 units on a scale | Standard Error 0.04 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -0.82 units on a scale | Standard Error 0.05 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -0.62 units on a scale | Standard Error 0.04 |
| Pooled Tanezumab 10 mg | 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 | -0.89 units on a scale | Standard Error 0.05 |
| Pooled Tanezumab 10 mg | 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 | -1.02 units on a scale | Standard Error 0.05 |
| Pooled Tanezumab 10 mg | 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 | -0.82 units on a scale | Standard Error 0.06 |
| Pooled Tanezumab 10 mg | 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 | -0.79 units on a scale | Standard Error 0.06 |
| Pooled Tanezumab 10 mg | 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 | -0.75 units on a scale | Standard Error 0.06 |
| Pooled Tanezumab 10 mg | 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 | -0.72 units on a scale | Standard Error 0.07 |
| Pooled Tanezumab 10 mg | 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 | -0.74 units on a scale | Standard Error 0.07 |
| Pooled Tanezumab 10 mg | 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 | -0.67 units on a scale | Standard Error 0.04 |
| Pooled Tanezumab 10 mg | 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 | -0.86 units on a scale | Standard Error 0.04 |
| Tramadol | 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 | -0.85 units on a scale | Standard Error 0.04 |
| Tramadol | 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 0.03 |
| Tramadol | 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 | -0.70 units on a scale | Standard Error 0.05 |
| Tramadol | 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 | -0.74 units on a scale | Standard Error 0.05 |
| Tramadol | 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 | -0.76 units on a scale | Standard Error 0.04 |
| Tramadol | 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 | -0.66 units on a scale | Standard Error 0.04 |
| Tramadol | 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 | -0.74 units on a scale | Standard Error 0.05 |
| Tramadol | 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 | -0.66 units on a scale | Standard Error 0.06 |
| Tramadol | 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 | -0.66 units on a scale | Standard Error 0.06 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.147295% CI: [-0.18, 0.03]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.013595% CI: [-0.24, -0.03]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.089395% CI: [-0.18, 0.01]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.004495% CI: [-0.23, -0.04]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.002595% CI: [-0.28, -0.06]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000295% CI: [-0.32, -0.1]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.834895% CI: [-0.11, 0.09]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.00295% CI: [-0.26, -0.06]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000195% CI: [-0.3, -0.1]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.027295% CI: [-0.25, -0.01]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000995% CI: [-0.31, -0.08]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.16895% CI: [-0.18, 0.03]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.296895% CI: [-0.16, 0.05]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.021995% CI: [-0.23, -0.02]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.071795% CI: [-0.25, 0.01]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.020795% CI: [-0.29, -0.02]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.839995% CI: [-0.11, 0.13]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.029995% CI: [-0.25, -0.01]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.00695% CI: [-0.29, -0.05]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.197495% CI: [-0.24, 0.05]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.27895% CI: [-0.22, 0.06]ANCOVA
Comparison: Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.43395% CI: [-0.21, 0.09]ANCOVA
Comparison: Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.494695% CI: [-0.2, 0.09]ANCOVA
Comparison: Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.188495% CI: [-0.25, 0.05]ANCOVA
Comparison: Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.52195% CI: [-0.2, 0.1]ANCOVA
Comparison: Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.332995% CI: [-0.23, 0.08]ANCOVA
Comparison: Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.517395% CI: [-0.21, 0.1]ANCOVA
Comparison: Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.234695% CI: [-0.25, 0.06]ANCOVA
Comparison: Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.363495% CI: [-0.23, 0.09]ANCOVA
Secondary
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo
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.
Time frame: Baseline, Week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | -6.27 units on a scale | Standard Error 0.35 |
| Pooled Tanezumab 10 mg | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | -6.69 units on a scale | Standard Error 0.35 |
| Tramadol | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | -5.21 units on a scale | Standard Error 0.3 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.003595% CI: [-2.21, -0.43]ANCOVA
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000295% CI: [-2.64, -0.83]ANCOVA
Secondary
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data
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.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'number analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Change at Week 64 | -8.71 units on a scale | Standard Deviation 5.78 |
| Pooled Tanezumab 5 mg | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Baseline | 14.98 units on a scale | Standard Deviation 5.03 |
| Pooled Tanezumab 5 mg | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Change at Week 80 | -7.27 units on a scale | Standard Deviation 6.79 |
| Pooled Tanezumab 10 mg | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Change at Week 64 | -8.72 units on a scale | Standard Deviation 6.32 |
| Pooled Tanezumab 10 mg | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Baseline | 15.02 units on a scale | Standard Deviation 5.21 |
| Pooled Tanezumab 10 mg | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Change at Week 80 | -8.80 units on a scale | Standard Deviation 6.68 |
| Tramadol | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Baseline | 15.06 units on a scale | Standard Deviation 4.92 |
| Tramadol | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Change at Week 80 | -7.13 units on a scale | Standard Deviation 5.99 |
| Tramadol | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Change at Week 64 | -7.64 units on a scale | Standard Deviation 5.96 |
| Tramadol | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Change at Week 64 | -8.87 units on a scale | Standard Deviation 5.88 |
| Tramadol | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Baseline | 15.10 units on a scale | Standard Deviation 5.11 |
| Tramadol | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Change at Week 80 | -8.35 units on a scale | Standard Deviation 6.01 |
Secondary
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
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -5.27 units on a scale | Standard Error 0.31 |
| Pooled Tanezumab 5 mg | 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 | -3.30 units on a scale | Standard Error 0.25 |
| Pooled Tanezumab 5 mg | 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 | -6.27 units on a scale | Standard Error 0.35 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -4.58 units on a scale | Standard Error 0.29 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -5.71 units on a scale | Standard Error 0.42 |
| Pooled Tanezumab 10 mg | 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 | -6.69 units on a scale | Standard Error 0.35 |
| Pooled Tanezumab 10 mg | 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 | -5.24 units on a scale | Standard Error 0.44 |
| Pooled Tanezumab 10 mg | 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 | -5.23 units on a scale | Standard Error 0.44 |
| Pooled Tanezumab 10 mg | 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 | -5.14 units on a scale | Standard Error 0.43 |
| Pooled Tanezumab 10 mg | 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 | -5.32 units on a scale | Standard Error 0.29 |
| Pooled Tanezumab 10 mg | 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 | -5.85 units on a scale | Standard Error 0.31 |
| Pooled Tanezumab 10 mg | 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 | -5.92 units on a scale | Standard Error 0.41 |
| Pooled Tanezumab 10 mg | 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 | -3.84 units on a scale | Standard Error 0.26 |
| Tramadol | 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 | -4.41 units on a scale | Standard Error 0.36 |
| Tramadol | 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 | -2.74 units on a scale | Standard Error 0.21 |
| Tramadol | 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 | -3.67 units on a scale | Standard Error 0.25 |
| Tramadol | 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 | -4.51 units on a scale | Standard Error 0.27 |
| Tramadol | 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 | -5.21 units on a scale | Standard Error 0.3 |
| Tramadol | 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 | -4.59 units on a scale | Standard Error 0.35 |
| Tramadol | 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 | -4.74 units on a scale | Standard Error 0.35 |
| Tramadol | 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 | -4.53 units on a scale | Standard Error 0.36 |
| Tramadol | 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 | -4.44 units on a scale | Standard Error 0.37 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.012195% CI: [-1.5, -0.18]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-2.05, -0.71]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.369795% CI: [-0.89, 0.33]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.065895% CI: [-1.16, 0.04]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000495% CI: [-1.7, -0.5]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.001395% CI: [-1.96, -0.48]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-2.7, -1.21]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.390695% CI: [-0.99, 0.39]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.008295% CI: [-1.6, -0.24]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-2.34, -0.97]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000695% CI: [-2.15, -0.58]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: <0.000195% CI: [-2.73, -1.16]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.038595% CI: [-1.47, -0.04]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000395% CI: [-2.06, -0.61]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.003595% CI: [-2.21, -0.43]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000295% CI: [-2.64, -0.83]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.541295% CI: [-1.09, 0.57]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.010795% CI: [-1.87, -0.25]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.000495% CI: [-2.29, -0.66]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.046495% CI: [-1.94, -0.02]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.006895% CI: [-2.3, -0.37]ANCOVA
Comparison: Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.148595% CI: [-1.7, 0.26]ANCOVA
Comparison: Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.050795% CI: [-1.94, 0]ANCOVA
Comparison: Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.24895% CI: [-1.6, 0.41]ANCOVA
Comparison: Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.160595% CI: [-1.71, 0.28]ANCOVA
Comparison: Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.365495% CI: [-1.5, 0.55]ANCOVA
Comparison: Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.178295% CI: [-1.71, 0.32]ANCOVA
Comparison: Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.398195% CI: [-1.47, 0.58]ANCOVA
Comparison: Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.p-value: 0.108995% CI: [-1.84, 0.18]ANCOVA
Secondary
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
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.
Time frame: Baseline, Weeks 16, 56 and 64
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 1.8 |
| Pooled Tanezumab 5 mg | 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 | -32.25 units on a scale | Standard Error 1.38 |
| Pooled Tanezumab 5 mg | 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 | -5.07 units on a scale | Standard Error 1.15 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | -29.49 units on a scale | Standard Error 1.71 |
| Pooled Tanezumab 5 mg | 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 | -30.49 units on a scale | Standard Error 1.75 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | -30.22 units on a scale | Standard Error 1.72 |
| Pooled Tanezumab 10 mg | 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 | -32.25 units on a scale | Standard Error 1.38 |
| Pooled Tanezumab 10 mg | 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 | -44.16 units on a scale | Standard Error 1.63 |
| Pooled Tanezumab 10 mg | 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 | -5.89 units on a scale | Standard Error 1.16 |
| Pooled Tanezumab 10 mg | 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 | -31.95 units on a scale | Standard Error 1.77 |
| Pooled Tanezumab 10 mg | 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 | -7.48 units on a scale | Standard Error 1.11 |
| Pooled Tanezumab 10 mg | 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 | -41.32 units on a scale | Standard Error 2.02 |
| Pooled Tanezumab 10 mg | 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 | -42.63 units on a scale | Standard Error 2.18 |
| Tramadol | 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 | -28.29 units on a scale | Standard Error 1.62 |
| Tramadol | 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 | -5.68 units on a scale | Standard Error 1.07 |
| Tramadol | 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 | -38.51 units on a scale | Standard Error 1.89 |
| Tramadol | 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 | -27.11 units on a scale | Standard Error 1.58 |
| Tramadol | 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 | -43.00 units on a scale | Standard Error 1.47 |
| Tramadol | 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 | -30.83 units on a scale | Standard Error 1.23 |
| Tramadol | 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 | -39.25 units on a scale | Standard Error 2.04 |
| Tramadol | 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 | -7.19 units on a scale | Standard Error 1.05 |
Comparison: Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.650895% CI: [-2.49, 3.98]ANCOVA
Comparison: Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.962995% CI: [-3.33, 3.18]ANCOVA
Comparison: Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.700795% CI: [-2.48, 3.69]ANCOVA
Comparison: Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.890295% CI: [-3.32, 2.88]ANCOVA
Comparison: Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.569895% CI: [-3.89, 2.15]ANCOVA
Comparison: Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.846495% CI: [-3.32, 2.72]ANCOVA
Comparison: Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.091995% CI: [-8.72, 0.66]ANCOVA
Comparison: Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.047795% CI: [-9.47, -0.05]ANCOVA
Comparison: Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.473595% CI: [-6.17, 2.87]ANCOVA
Comparison: Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.293595% CI: [-6.82, 2.06]ANCOVA
Comparison: Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.171495% CI: [-7.56, 1.35]ANCOVA
Comparison: Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.752195% CI: [-6.3, 4.56]ANCOVA
Comparison: Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.307895% CI: [-8.24, 2.61]ANCOVA
Comparison: Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.10995% CI: [-8.78, 0.88]ANCOVA
Comparison: Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.028995% CI: [-10.27, -0.56]ANCOVA
Comparison: Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.461395% CI: [-6.41, 2.91]ANCOVA
Comparison: Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.34695% CI: [-6.78, 2.38]ANCOVA
Comparison: Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.117995% CI: [-8.26, 0.93]ANCOVA
Comparison: Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.515195% CI: [-7.78, 3.92]ANCOVA
Comparison: Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.25595% CI: [-9.22, 2.46]ANCOVA
Comparison: Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.015795% CI: [-7.57, -0.79]ANCOVA
Comparison: Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.015995% CI: [-7.57, -0.78]ANCOVA
Comparison: Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.089695% CI: [-5.94, 0.43]ANCOVA
Comparison: Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.374995% CI: [-4.57, 1.72]ANCOVA
Comparison: Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.373395% CI: [-4.55, 1.71]ANCOVA
Comparison: Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.805695% CI: [-4.8, 3.73]ANCOVA
Comparison: Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.576495% CI: [-5.25, 2.93]ANCOVA
Secondary
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
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.
Time frame: Screening (up to maximum of 37 days prior to Baseline), Weeks 24, 56 and 80
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Screening | 0.43 units on a scale | Standard Deviation 0.75 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total Symptom Impact Score: Screening | 0.95 units on a scale | Standard Deviation 1.69 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total Symptom Impact Score: Change at Week 56 | 0.96 units on a scale | Standard Deviation 3.87 |
| Pooled Tanezumab 10 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 80 | 0.42 units on a scale | Standard Deviation 1.45 |
| Pooled Tanezumab 10 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total Symptom Impact Score: Screening | 1.10 units on a scale | Standard Deviation 1.88 |
| Pooled Tanezumab 10 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Screening | 0.50 units on a scale | Standard Deviation 0.82 |
| Pooled Tanezumab 10 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total Symptom Impact Score: Change at Week 24 | 0.76 units on a scale | Standard Deviation 3.55 |
| Pooled Tanezumab 10 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 24 | 0.28 units on a scale | Standard Deviation 1.37 |
| Pooled Tanezumab 10 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total Symptom Impact Score: Change at Week 80 | 1.28 units on a scale | Standard Deviation 4.1 |
| Pooled Tanezumab 10 mg | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 56 | 0.30 units on a scale | Standard Deviation 1.37 |
| Tramadol | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 24 | 0.51 units on a scale | Standard Deviation 1.34 |
| Tramadol | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Screening | 0.48 units on a scale | Standard Deviation 0.74 |
| Tramadol | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 80 | 0.45 units on a scale | Standard Deviation 1.47 |
| Tramadol | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total Symptom Impact Score: Change at Week 80 | 1.43 units on a scale | Standard Deviation 3.94 |
| Tramadol | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total Symptom Impact Score: Change at Week 56 | 1.74 units on a scale | Standard Deviation 3.96 |
| Tramadol | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total Symptom Impact Score: Change at Week 24 | 1.37 units on a scale | Standard Deviation 3.68 |
| Tramadol | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total Symptom Impact Score: Screening | 1.06 units on a scale | Standard Deviation 1.71 |
| Tramadol | Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 56 | 0.60 units on a scale | Standard Deviation 1.49 |
Secondary
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
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.
Time frame: Baseline, Weeks 8, 16, 24, 40 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants evaluable for this OM for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 0.9 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 2.8 units on a scale | Standard Deviation 0.9 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 0.64 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.6 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.4 units on a scale | Standard Deviation 0.71 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Mobility | 1.5 units on a scale | Standard Deviation 0.72 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Self-care | 1.3 units on a scale | Standard Deviation 0.52 |
| Pooled Tanezumab 5 mg | 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 0.89 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Pain/Discomfort | 1.9 units on a scale | Standard Deviation 0.66 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Self-care | 2.1 units on a scale | Standard Deviation 0.97 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 2.6 units on a scale | Standard Deviation 0.88 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.6 units on a scale | Standard Deviation 0.84 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.9 units on a scale | Standard Deviation 1.03 |
| Pooled Tanezumab 5 mg | 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 0.69 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Anxiety/Depression | 1.6 units on a scale | Standard Deviation 0.92 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Self-care | 1.3 units on a scale | Standard Deviation 0.53 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Usual activities | 2.0 units on a scale | Standard Deviation 0.85 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 2.8 units on a scale | Standard Deviation 0.83 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Mobility | 1.5 units on a scale | Standard Deviation 0.62 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.64 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Pain/Discomfort | 1.9 units on a scale | Standard Deviation 0.7 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Anxiety/Depression | 1.5 units on a scale | Standard Deviation 0.82 |
| Pooled Tanezumab 5 mg | 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 0.55 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Mobility | 1.6 units on a scale | Standard Deviation 0.79 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 2.0 units on a scale | Standard Deviation 0.9 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Self-care | 1.4 units on a scale | Standard Deviation 0.75 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Usual activities | 1.7 units on a scale | Standard Deviation 0.71 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Pain/Discomfort | 2.4 units on a scale | Standard Deviation 0.86 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Self-care | 1.7 units on a scale | Standard Deviation 0.79 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.5 units on a scale | Standard Deviation 0.72 |
| Pooled Tanezumab 5 mg | 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 0.73 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 1.8 units on a scale | Standard Deviation 0.85 |
| Pooled Tanezumab 10 mg | 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 0.72 |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 2.8 units on a scale | Standard Deviation 0.82 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.9 units on a scale | Standard Deviation 1.01 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 1.8 units on a scale | Standard Deviation 0.85 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Usual activities | 2.0 units on a scale | Standard Deviation 0.85 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.5 units on a scale | Standard Deviation 0.8 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Usual activities | 1.8 units on a scale | Standard Deviation 0.84 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Anxiety/Depression | 1.5 units on a scale | Standard Deviation 0.83 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Mobility | 1.6 units on a scale | Standard Deviation 0.75 |
| Pooled Tanezumab 10 mg | 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 0.71 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Pain/Discomfort | 2.1 units on a scale | Standard Deviation 0.76 |
| Pooled Tanezumab 10 mg | 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 0.46 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Pain/Discomfort | 2.0 units on a scale | Standard Deviation 0.73 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Self-care | 1.2 units on a scale | Standard Deviation 0.55 |
| Pooled Tanezumab 10 mg | 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 0.78 |
| Pooled Tanezumab 10 mg | 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 0.72 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.77 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 2.5 units on a scale | Standard Deviation 0.83 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.4 units on a scale | Standard Deviation 0.68 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Self-care | 1.4 units on a scale | Standard Deviation 0.66 |
| Pooled Tanezumab 10 mg | 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 0.83 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 1.7 units on a scale | Standard Deviation 0.78 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.3 units on a scale | Standard Deviation 0.62 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Pain/Discomfort | 2.2 units on a scale | Standard Deviation 0.83 |
| Pooled Tanezumab 10 mg | 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 0.58 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.73 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Mobility | 1.5 units on a scale | Standard Deviation 0.75 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.64 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Mobility | 1.5 units on a scale | Standard Deviation 0.69 |
| Tramadol | 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 0.45 |
| Tramadol | 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 0.74 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Pain/Discomfort | 2.2 units on a scale | Standard Deviation 0.75 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Usual activities | 1.7 units on a scale | Standard Deviation 0.68 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.65 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Usual activities | 2.0 units on a scale | Standard Deviation 0.82 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Mobility | 1.5 units on a scale | Standard Deviation 0.7 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 1.8 units on a scale | Standard Deviation 0.81 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Usual activities | 1.8 units on a scale | Standard Deviation 0.8 |
| Tramadol | 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 0.77 |
| Tramadol | 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 0.73 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.3 units on a scale | Standard Deviation 0.61 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 1.6 units on a scale | Standard Deviation 0.75 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.9 units on a scale | Standard Deviation 0.98 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.68 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Usual activities | 1.7 units on a scale | Standard Deviation 0.67 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Mobility | 1.4 units on a scale | Standard Deviation 0.67 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Self-care | 1.2 units on a scale | Standard Deviation 0.43 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Mobility | 1.5 units on a scale | Standard Deviation 0.66 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 2.6 units on a scale | Standard Deviation 0.82 |
| Tramadol | 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 0.7 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Self-care | 2.0 units on a scale | Standard Deviation 0.92 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Self-care | 1.4 units on a scale | Standard Deviation 0.65 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Pain/Discomfort | 1.9 units on a scale | Standard Deviation 0.72 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 2.8 units on a scale | Standard Deviation 0.8 |
| Tramadol | 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 0.75 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.4 units on a scale | Standard Deviation 0.8 |
| Tramadol | 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 0.78 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.3 units on a scale | Standard Deviation 0.69 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Self-care | 1.2 units on a scale | Standard Deviation 0.51 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.3 units on a scale | Standard Deviation 0.7 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Pain/Discomfort | 2.0 units on a scale | Standard Deviation 0.72 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 1.9 units on a scale | Standard Deviation 0.87 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.5 units on a scale | Standard Deviation 0.79 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Usual activities | 2.1 units on a scale | Standard Deviation 0.91 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Anxiety/Depression | 1.6 units on a scale | Standard Deviation 0.84 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Usual activities | 1.7 units on a scale | Standard Deviation 0.82 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 1.8 units on a scale | Standard Deviation 0.79 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 2.6 units on a scale | Standard Deviation 0.86 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Self-care | 1.3 units on a scale | Standard Deviation 0.62 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.66 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Pain/Discomfort | 2.1 units on a scale | Standard Deviation 0.75 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Anxiety/Depression | 1.5 units on a scale | Standard Deviation 0.79 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Mobility | 1.7 units on a scale | Standard Deviation 0.75 |
| Tramadol | 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 0.59 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Usual activities | 1.7 units on a scale | Standard Deviation 0.72 |
| Tramadol | 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 0.76 |
| Tramadol | 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 0.74 |
| Tramadol | 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 0.82 |
| Tramadol | 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 0.73 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Mobility | 1.6 units on a scale | Standard Deviation 0.73 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.5 units on a scale | Standard Deviation 0.69 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Usual activities | 1.7 units on a scale | Standard Deviation 0.76 |
| Tramadol | 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 0.63 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Self-care | 1.4 units on a scale | Standard Deviation 0.66 |
| Tramadol | 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 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 56: Mobility | 1.6 units on a scale | Standard Deviation 0.83 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 2.8 units on a scale | Standard Deviation 0.84 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 40: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.63 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.9 units on a scale | Standard Deviation 1 |
Secondary
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
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.
Time frame: Baseline, Weeks 8, 16, 24, 40, 56 and 64
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants evaluable for this OM at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 0.1 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Baseline | 0.61 units on a scale | Standard Deviation 0.15 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 8 | 0.71 units on a scale | Standard Deviation 0.14 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 16 | 0.75 units on a scale | Standard Deviation 0.14 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 24 | 0.81 units on a scale | Standard Deviation 0.13 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 40 | 0.82 units on a scale | Standard Deviation 0.12 |
| Pooled Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 56 | 0.82 units on a scale | Standard Deviation 0.13 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 40 | 0.82 units on a scale | Standard Deviation 0.12 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 56 | 0.82 units on a scale | Standard Deviation 0.14 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 24 | 0.80 units on a scale | Standard Deviation 0.13 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 16 | 0.78 units on a scale | Standard Deviation 0.14 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Baseline | 0.61 units on a scale | Standard Deviation 0.16 |
| Pooled Tanezumab 10 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 8 | 0.75 units on a scale | Standard Deviation 0.13 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 56 | 0.84 units on a scale | Standard Deviation 0.12 |
| Tramadol | 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 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 8 | 0.76 units on a scale | Standard Deviation 0.14 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 16 | 0.79 units on a scale | Standard Deviation 0.13 |
| Tramadol | 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 0.12 |
| Tramadol | 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 0.12 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 40 | 0.80 units on a scale | Standard Deviation 0.14 |
| Tramadol | 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 0.14 |
| Tramadol | 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 0.13 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 56 | 0.81 units on a scale | Standard Deviation 0.14 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 24 | 0.80 units on a scale | Standard Deviation 0.12 |
| Tramadol | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Baseline | 0.61 units on a scale | Standard Deviation 0.16 |
Secondary
Health Care Resource Utilization (HCRU): Duration Since Quitting 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 duration since quitting job due to low back pain.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population. Not all participants of the ITT population had data collected at each of the time points for this outcome measure. 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 80 | 8.6 years |
| Placebo | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 64 | 1.1 years |
| Placebo | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Baseline | 2.0 years |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Baseline | 2.0 years |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 64 | 5.2 years |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 80 | 4.7 years |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Baseline | 1.0 years |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 64 | 2.2 years |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 80 | 0.2 years |
| Tramadol | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 80 | 3.5 years |
| Tramadol | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 64 | 2.0 years |
| Tramadol | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Baseline | 3.8 years |
| Tramadol | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Baseline | 2.3 years |
| Tramadol | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 64 | 2.5 years |
| Tramadol | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Week 80 | 3.5 years |
Secondary
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital 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 nights stayed in the hospital due to low back pain.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain | Week 80 | 3.0 nights |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain | Week 80 | 2.0 nights |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain | Baseline | 9.0 nights |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain | Week 64 | 1.0 nights |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain | Week 64 | 1.0 nights |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain | Baseline | 1.0 nights |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain | Week 80 | 2.0 nights |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized 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 were hospitalized due to low back pain.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n'= Participants who were evaluable for hospitalization due to low back pain at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 64 | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Baseline | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 80 | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Baseline | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 80 | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 64 | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Baseline | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 64 | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 80 | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 80 | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Baseline | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 64 | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 64 | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Baseline | 4 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Week 80 | 1 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Who Quit 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.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants who were evaluable for quiting job due to low back pain.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Baseline | 17 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 80 | 4 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 64 | 6 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 64 | 2 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Baseline | 14 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 80 | 2 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 64 | 11 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Baseline | 28 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 80 | 4 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Baseline | 31 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 80 | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 64 | 8 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 64 | 14 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Baseline | 47 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Week 80 | 3 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Who Used 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.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants who were evaluable for usage of any aids/devices for doing things.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Rarely | 2 Participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Rarely | 2 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Never | 135 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Never | 186 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Rarely | 0 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Often | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Never | 61 Participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Sometimes | 0 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Rarely | 0 Participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Often | 10 Participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Sometimes | 5 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Always | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Rarely | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Never | 125 Participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Sometimes | 0 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Always | 0 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Often | 0 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Sometimes | 3 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Often | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Always | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Always | 1 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Never | 55 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Sometimes | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Always | 2 Participants |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Rarely | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Never | 188 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Sometimes | 2 Participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Never | 199 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Always | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Always | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Often | 6 Participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Rarely | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Sometimes | 6 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Always | 4 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Never | 131 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Never | 135 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Sometimes | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Often | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Always | 2 Participants |
| Pooled Tanezumab 5 mg | 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 | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Never | 138 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Device/Utensil to dress bathe eat | Always | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Rarely | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Sometimes | 0 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Often | 0 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Always | 0 Participants |
| Pooled Tanezumab 5 mg | 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 | 137 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Rarely | 2 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Often | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Always | 0 Participants |
| Pooled Tanezumab 5 mg | 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 | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Never | 59 Participants |
| Pooled Tanezumab 5 mg | 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 | 57 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Rarely | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Often | 5 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Often | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Never | 196 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Always | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Never | 58 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Sometimes | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Sometimes | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Often | 0 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Never | 190 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Always | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Sometimes | 4 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Rarely | 4 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Always | 3 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Often | 5 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Often | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Never | 204 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Rarely | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Sometimes | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Sometimes | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Often | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Always | 0 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Rarely | 0 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Rarely | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Never | 56 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Sometimes | 3 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Often | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Always | 3 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Never | 188 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Sometimes | 1 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Rarely | 2 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Sometimes | 5 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Sometimes | 12 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Rarely | 1 Participants |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Often | 4 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Rarely | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Often | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Rarely | 2 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Never | 283 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Always | 3 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Always | 3 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Rarely | 3 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Rarely | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Sometimes | 6 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Never | 403 Participants |
| Pooled Tanezumab 10 mg | 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 | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Sometimes | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Never | 277 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Never | 387 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Device/Utensil to dress bathe eat | Always | 0 Participants |
| Pooled Tanezumab 10 mg | 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 | 283 Participants |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Sometimes | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Always | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Often | 0 Participants |
| Pooled Tanezumab 10 mg | 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 | 2 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Often | 6 Participants |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Often | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Often | 4 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Device/Utensil to dress bathe eat | Sometimes | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Rarely | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Sometimes | 1 Participants |
| Pooled Tanezumab 10 mg | 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 | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Always | 2 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Always | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Sometimes | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Always | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Rarely | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Often | 3 Participants |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Always | 3 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Never | 128 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Never | 134 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Sometimes | 2 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Often | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Never | 390 Participants |
| Pooled Tanezumab 10 mg | 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 | 132 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Rarely | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Always | 3 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Often | 0 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Never | 130 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Never | 376 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Sometimes | 10 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Always | 1 Participants |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Rarely | 11 Participants |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Often | 1 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Never | 277 Participants |
| Tramadol | 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 | 280 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Rarely | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Never | 396 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Always | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Rarely | 5 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Sometimes | 11 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Often | 6 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Never | 273 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Often | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Rarely | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Always | 1 Participants |
| Tramadol | 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 | 2 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Device/Utensil to dress bathe eat | Always | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Never | 273 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Rarely | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Sometimes | 7 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Often | 3 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Never | 141 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Never | 142 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Rarely | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Sometimes | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Often | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Device/Utensil to dress bathe eat | Sometimes | 0 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Sometimes | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Often | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Never | 371 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Rarely | 9 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Sometimes | 16 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Often | 7 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Always | 4 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Never | 405 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Sometimes | 2 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Often | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Always | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Rarely | 1 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Often | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Never | 382 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Always | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Rarely | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Sometimes | 5 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Always | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Never | 283 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Sometimes | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Often | 0 Participants |
| Tramadol | 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 | 3 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Rarely | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Sometimes | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Often | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Always | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Always | 0 Participants |
| Tramadol | 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 | 142 Participants |
| Tramadol | 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 | 1 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Never | 139 Participants |
| Tramadol | 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 |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Always | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Never | 550 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Often | 4 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Never | 596 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Always | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Often | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Often | 17 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Rarely | 2 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Sometimes | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Rarely | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Never | 601 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Sometimes | 27 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Often | 2 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Always | 5 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Often | 9 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Sometimes | 15 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Rarely | 7 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Never | 569 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Never | 184 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Always | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Sometimes | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Rarely | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Often | 0 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Device/Utensil to dress bathe eat | Sometimes | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Sometimes | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Rarely | 8 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Always | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Rarely | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Wheelchair use | Never | 190 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Sometimes | 4 Participants |
| Tramadol | 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 |
| Tramadol | 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 | 190 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Walking aid use | Never | 182 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Always | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Often | 7 Participants |
| Tramadol | 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 |
| Tramadol | 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 | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Sometimes | 8 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Never | 387 Participants |
| Tramadol | 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 | 2 Participants |
| Tramadol | 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 | 410 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Always | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Often | 2 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 80: Other aids or devices | Always | 2 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Often | 1 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Sometimes | 1 Participants |
| Tramadol | 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 |
| Tramadol | 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 | 2 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Never | 397 Participants |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Rarely | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Wheelchair use | Never | 412 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Always | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Sometimes | 9 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Walking aid use | Rarely | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 64: Other aids or devices | Rarely | 9 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room 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 visited the emergency room due to low back pain.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' signifies the number of participants who had visited the emergency room at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Baseline | 10 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 80 | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 64 | 4 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 64 | 2 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Baseline | 14 Participants |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 80 | 3 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 80 | 3 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Baseline | 27 Participants |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 64 | 7 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 80 | 0 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Baseline | 17 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 64 | 5 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 64 | 3 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Baseline | 26 Participants |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain | Week 80 | 4 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
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.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = Participants evaluable for this OM for specified categories.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Orthopedist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Neurologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Home healthcare services | 7.5 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Radiologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Rheumatologist | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Podiatrist | 2.0 visits |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Pain specialist | 2.0 visits |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Physical therapist | 6.5 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Podiatrist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Other practitioner | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Primary Care Physician | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Other practitioner | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Pain specialist | 2.0 visits |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Pain specialist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Neurologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Other practitioner | 1.0 visits |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Radiologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Podiatrist | 1.5 visits |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Orthopedist | 3.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Chiropractor | 6.0 visits |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Rheumatologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Radiologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Physical therapist | 10.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Orthopedist | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Chiropractor | 3.0 visits |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Physical therapist | 5.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Chiropractor | 401.0 visits |
| Placebo | 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 |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Nutritionist/dietitian | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Rheumatologist | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Neurologist | 1.0 visits |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Alternative medicine or therapy | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Neurologist | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Radiologist | 1.5 visits |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Chiropractor | 2.5 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Rheumatologist | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Nutritionist/dietitian | 3.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Primary Care Physician | 2.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Neurologist | 1.5 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline:Physician assistant or nurse Practitioner | 2.0 visits |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Physical therapist | 8.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Pain specialist | 2.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Other practitioner | 2.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Orthopedist | 3.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Physical therapist | 8.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Nutritionist/dietitian | 10.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Chiropractor | 3.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Home healthcare services | 6.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Chiropractor | 3.5 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Primary Care Physician | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Physical therapist | 12.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Other practitioner | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Pain specialist | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Neurologist | 2.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Rheumatologist | 1.0 visits |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Physician assistant or nurse Practitioner | 50.5 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Rheumatologist | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Podiatrist | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Radiologist | 1.5 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Orthopedist | 1.5 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Home healthcare services | 3.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Alternative medicine or therapy | 2.5 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Pain specialist | 2.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Podiatrist | 2.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Other practitioner | 2.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Nutritionist/dietitian | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Orthopedist | 2.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Pain specialist | 2.5 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Rheumatologist | 2.0 visits |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Pain specialist | 2.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Orthopedist | 3.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Radiologist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Neurologist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Nutritionist/dietitian | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Home healthcare services | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Other practitioner | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Primary Care Physician | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Rheumatologist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Orthopedist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Physical therapist | 4.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Alternative medicine or therapy | 3.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Radiologist | 1.5 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Primary Care Physician | 2.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Neurologist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Physical therapist | 4.5 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Chiropractor | 3.5 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Alternative medicine or therapy | 3.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Podiatrist | 2.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Nutritionist/dietitian | 1.5 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Other practitioner | 1.0 visits |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Rheumatologist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Physician assistant or nurse Practitioner | 2.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Pain specialist | 2.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Orthopedist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Physical therapist | 4.5 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Chiropractor | 2.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Alternative medicine or therapy | 2.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Podiatrist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Radiologist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Neurologist | 2.5 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Physician assistant or nurse Practitioner | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Chiropractor | 4.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Podiatrist | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Nutritionist/dietitian | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Home healthcare services | 4.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Other practitioner | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Physical therapist | 5.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Radiologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Radiologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Podiatrist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Neurologist | 1.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Alternative medicine or therapy | 2.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Physical therapist | 5.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Nutritionist/dietitian | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Orthopedist | 1.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Pain specialist | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Pain specialist | 1.0 visits |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Home healthcare services | 2.0 visits |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Radiologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Nutritionist/dietitian | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Nutritionist/dietitian | 4.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Alternative medicine or therapy | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Chiropractor | 3.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Podiatrist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Physical therapist | 4.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Orthopedist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Other practitioner | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Primary Care Physician | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Pain specialist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Neurologist | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Rheumatologist | 1.0 visits |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Other practitioner | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Physician assistant or nurse Practitioner | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Rheumatologist | 1.0 visits |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Other practitioner | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Home healthcare services | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Chiropractor | 3.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Orthopedist | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Chiropractor | 4.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Podiatrist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Rheumatologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Neurologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Primary Care Physician | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Neurologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Other practitioner | 1.0 visits |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Chiropractor | 3.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Primary Care Physician | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Radiologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Neurologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Pain specialist | 2.0 visits |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Neurologist | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Rheumatologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Home healthcare services | 24.5 visits |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Pain specialist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Podiatrist | 1.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Rheumatologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Physician assistant or nurse Practitioner | 2.0 visits |
| Tramadol | 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 |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Rheumatologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Home healthcare services | 16.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Alternative medicine or therapy | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Physical therapist | 3.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Home healthcare services | 6.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Radiologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Podiatrist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Chiropractor | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Primary Care Physician | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Other practitioner | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Orthopedist | 1.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Chiropractor | 3.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Alternative medicine or therapy | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Physical therapist | 6.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Orthopedist | 3.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Physical therapist | 3.5 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Podiatrist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Nutritionist/dietitian | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Other practitioner | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 80: Radiologist | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Orthopedist | 2.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Baseline: Nutritionist/dietitian | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Week 64: Pain specialist | 1.0 visits |
Secondary
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room 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 visits to the emergency room due to low back pain.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Baseline | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Week 64 | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Week 64 | 2.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Baseline | 1.0 visits |
| Pooled Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Week 80 | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Week 64 | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Week 80 | 1.0 visits |
| Pooled Tanezumab 10 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Baseline | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Baseline | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Week 64 | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Baseline | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Week 64 | 1.0 visits |
| Tramadol | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain | Week 80 | 1.5 visits |
Secondary
Number of Days of Rescue Medication Used at Week 64
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.
Time frame: Week 64
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Days of Rescue Medication Used at Week 64 | 1.3 days | Standard Deviation 1.59 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Week 64 | 1.3 days | Standard Deviation 2.02 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Week 64 | 1.3 days | Standard Deviation 1.99 |
| Tramadol | Number of Days of Rescue Medication Used at Week 64 | 1.4 days | Standard Deviation 2.16 |
| Tramadol | Number of Days of Rescue Medication Used at Week 64 | 1.8 days | Standard Deviation 2.44 |
Secondary
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
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.
Time frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 12 | 1.02 days | Standard Error 0.11 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 4 | 1.40 days | Standard Error 0.12 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 32 | 1.36 days | Standard Error 0.15 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 56 | 1.22 days | Standard Error 0.13 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 16 | 0.96 days | Standard Error 0.11 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 8 | 1.15 days | Standard Error 0.11 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 2 | 1.85 days | Standard Error 0.14 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 48 | 1.25 days | Standard Error 0.14 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 24 | 1.35 days | Standard Error 0.14 |
| Pooled Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 40 | 1.24 days | Standard Error 0.14 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 4 | 1.46 days | Standard Error 0.1 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 8 | 1.23 days | Standard Error 0.09 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 40 | 1.37 days | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 16 | 0.99 days | Standard Error 0.09 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 24 | 1.32 days | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 12 | 1.11 days | Standard Error 0.09 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 56 | 1.42 days | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 32 | 1.38 days | Standard Error 0.12 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 2 | 1.76 days | Standard Error 0.11 |
| Pooled Tanezumab 10 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | Week 48 | 1.37 days | Standard Error 0.12 |
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.127295% CI: [0.96, 1.41]Negative binomial model
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.632295% CI: [0.86, 1.27]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.355995% CI: [0.89, 1.36]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.679895% CI: [0.77, 1.18]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.26795% CI: [0.9, 1.44]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.586595% CI: [0.74, 1.19]Negative binomial model
Comparison: Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.337895% CI: [0.88, 1.47]Negative binomial model
Comparison: Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.55195% CI: [0.71, 1.2]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.208895% CI: [0.9, 1.6]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.869295% CI: [0.73, 1.3]Negative binomial model
Comparison: Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.844495% CI: [0.78, 1.35]Negative binomial model
Comparison: Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.893695% CI: [0.78, 1.34]Negative binomial model
Comparison: Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.871695% CI: [0.75, 1.28]Negative binomial model
Comparison: Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.882795% CI: [0.75, 1.29]Negative binomial model
Comparison: Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.899695% CI: [0.77, 1.34]Negative binomial model
Comparison: Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.48895% CI: [0.69, 1.2]Negative binomial model
Comparison: Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.793895% CI: [0.73, 1.27]Negative binomial model
Comparison: Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.509295% CI: [0.69, 1.2]Negative binomial model
Comparison: Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.614895% CI: [0.71, 1.22]Negative binomial model
Comparison: Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.p-value: 0.284495% CI: [0.66, 1.13]Negative binomial model
Secondary
Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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.
Time frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 131 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 62 Participants |
| Pooled Tanezumab 5 mg | 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 | 115 Participants |
| Pooled Tanezumab 5 mg | 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 | 168 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | 149 Participants |
| Pooled Tanezumab 10 mg | 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 | 140 Participants |
| Pooled Tanezumab 10 mg | 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 | 144 Participants |
| Pooled Tanezumab 10 mg | 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 | 179 Participants |
| Pooled Tanezumab 10 mg | 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 | 158 Participants |
| Pooled Tanezumab 10 mg | 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 | 151 Participants |
| Pooled Tanezumab 10 mg | 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 | 130 Participants |
| Pooled Tanezumab 10 mg | 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 | 76 Participants |
| Pooled Tanezumab 10 mg | 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 | 160 Participants |
| Tramadol | 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 | 178 Participants |
| Tramadol | 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 | 207 Participants |
| Tramadol | 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 | 204 Participants |
| Tramadol | 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 | 211 Participants |
| Tramadol | 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 | 192 Participants |
| Tramadol | 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 | 202 Participants |
| Tramadol | 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 | 134 Participants |
| Tramadol | 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 | 74 Participants |
| Tramadol | 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 | 197 Participants |
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.00195% CI: [1.36, 3.36]Regression, Logistic
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: <0.000195% CI: [1.73, 4.16]Regression, Logistic
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.0395% CI: [1.05, 2.51]Regression, Logistic
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: <0.000195% CI: [1.44, 2.86]Regression, Logistic
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: <0.000195% CI: [1.69, 3.32]Regression, Logistic
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.02995% CI: [1.04, 1.99]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.000395% CI: [1.31, 2.47]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: <0.000195% CI: [1.62, 3.03]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.003395% CI: [1.16, 2.1]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.017995% CI: [1.06, 1.88]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.002195% CI: [1.18, 2.08]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.662995% CI: [0.81, 1.38]Regression, Logistic
Comparison: Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.025195% CI: [1.04, 1.75]Regression, Logistic
Comparison: Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.127895% CI: [0.94, 1.59]Regression, Logistic
Comparison: Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.074995% CI: [0.98, 1.65]Regression, Logistic
Comparison: Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.063395% CI: [0.99, 1.66]Regression, Logistic
Comparison: Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.062695% CI: [0.99, 1.67]Regression, Logistic
Comparison: Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.272795% CI: [0.89, 1.51]Regression, Logistic
Comparison: Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.174995% CI: [0.92, 1.57]Regression, Logistic
Comparison: Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.523995% CI: [0.84, 1.42]Regression, Logistic
Comparison: Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.333695% CI: [0.87, 1.49]Regression, Logistic
Comparison: Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.p-value: 0.216395% CI: [0.91, 1.54]Regression, Logistic
Secondary
Number of Participants Who Took Rescue Medication During Week 64: Observed Data
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.
Time frame: Week 64
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Took Rescue Medication During Week 64: Observed Data | 35 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Week 64: Observed Data | 26 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Week 64: Observed Data | 59 Participants |
| Tramadol | Number of Participants Who Took Rescue Medication During Week 64: Observed Data | 70 Participants |
| Tramadol | Number of Participants Who Took Rescue Medication During Week 64: Observed Data | 99 Participants |
Secondary
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
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.
Time frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here,N=participants evaluable for this OM and n participants evaluable for OM at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 2 | 208 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 8 | 158 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 16 | 125 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 32 | 152 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 48 | 144 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 4 | 175 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 12 | 147 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 24 | 150 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 40 | 144 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 2 | 318 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 24 | 211 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 32 | 210 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 4 | 285 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 56 | 215 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 40 | 209 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 48 | 210 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 12 | 216 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 16 | 193 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | Week 8 | 250 Participants |
Comparison: Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.39695% CI: [0.87, 1.44]Regression, Logistic
Comparison: Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.593295% CI: [0.73, 1.2]Regression, Logistic
Comparison: Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.332695% CI: [0.88, 1.46]Regression, Logistic
Comparison: Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.176595% CI: [0.65, 1.08]Regression, Logistic
Comparison: Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.561995% CI: [0.84, 1.39]Regression, Logistic
Comparison: Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.390995% CI: [0.69, 1.16]Regression, Logistic
Comparison: Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.756295% CI: [0.8, 1.35]Regression, Logistic
Comparison: Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.947695% CI: [0.78, 1.31]Regression, Logistic
Comparison: Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.774695% CI: [0.79, 1.36]Regression, Logistic
Comparison: Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.637795% CI: [0.71, 1.23]Regression, Logistic
Comparison: Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.853295% CI: [0.79, 1.33]Regression, Logistic
Comparison: Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.564495% CI: [0.83, 1.4]Regression, Logistic
Comparison: Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.7690.769% CI: [0.8, 1.35]Regression, Logistic
Comparison: Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.432195% CI: [0.85, 1.44]Regression, Logistic
Comparison: Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.771495% CI: [0.8, 1.35]Regression, Logistic
Comparison: Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.838995% CI: [0.79, 1.34]Regression, Logistic
Comparison: Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.938395% CI: [0.76, 1.29]Regression, Logistic
Comparison: Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.8895% CI: [0.78, 1.33]Regression, Logistic
Comparison: Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.794695% CI: [0.74, 1.26]Regression, Logistic
Comparison: Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.p-value: 0.780395% CI: [0.74, 1.25]Regression, Logistic
Secondary
Number of Participants Who Withdrew Due to Lack of Efficacy
Number of participants who withdrew from treatment due to lack of efficacy have been reported here.
Time frame: Baseline up to Week 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Withdrew Due to Lack of Efficacy | 25 Participants |
| Pooled Tanezumab 5 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 41 Participants |
| Pooled Tanezumab 10 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 41 Participants |
| Tramadol | Number of Participants Who Withdrew Due to Lack of Efficacy | 46 Participants |
| Tramadol | Number of Participants Who Withdrew Due to Lack of Efficacy | 65 Participants |
Comparison: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.736695% CI: [0.62, 1.41]Regression, Logistic
Comparison: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.77195% CI: [0.71, 1.58]Regression, Logistic
Secondary
Number of Participants With Anti Tanezumab Antibodies
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.
Time frame: Baseline, Weeks 8, 16, 32, 40, 48, 56, 64 and 80
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Anti Tanezumab Antibodies | Week 16 | 27 Participants |
| Placebo | Number of Participants With Anti Tanezumab Antibodies | Week 8 | 37 Participants |
| Placebo | Number of Participants With Anti Tanezumab Antibodies | Baseline | 45 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 8 | 32 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Baseline | 38 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 64 | 15 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 16 | 36 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 56 | 22 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 80 | 14 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 32 | 32 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 48 | 31 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Anti Tanezumab Antibodies | Week 32 | 48 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Anti Tanezumab Antibodies | Baseline | 39 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Anti Tanezumab Antibodies | Week 8 | 54 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Anti Tanezumab Antibodies | Week 16 | 46 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Anti Tanezumab Antibodies | Week 48 | 49 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Anti Tanezumab Antibodies | Week 56 | 41 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Anti Tanezumab Antibodies | Week 64 | 32 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Anti Tanezumab Antibodies | Week 80 | 14 Participants |
| Tramadol | Number of Participants With Anti Tanezumab Antibodies | Baseline | 68 Participants |
| Tramadol | Number of Participants With Anti Tanezumab Antibodies | Week 56 | 21 Participants |
| Tramadol | Number of Participants With Anti Tanezumab Antibodies | Week 8 | 49 Participants |
| Tramadol | Number of Participants With Anti Tanezumab Antibodies | Week 80 | 19 Participants |
| Tramadol | Number of Participants With Anti Tanezumab Antibodies | Week 32 | 23 Participants |
| Tramadol | Number of Participants With Anti Tanezumab Antibodies | Week 64 | 19 Participants |
| Tramadol | Number of Participants With Anti Tanezumab Antibodies | Week 48 | 23 Participants |
| Tramadol | Number of Participants With Anti Tanezumab Antibodies | Week 16 | 32 Participants |
Secondary
Number of Participants With Confirmed Orthostatic Hypotension
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 80 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 1 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 64 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 56 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 40 | 0 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 56 | 0 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 40 | 0 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 80 | 1 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 64 | 1 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 1 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 0 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 1 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 0 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 2 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 1 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 80 | 1 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 0 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 0 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 1 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 0 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 40 | 0 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 0 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 64 | 0 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 0 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 56 | 1 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 0 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 0 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 80 | 0 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 1 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 2 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 0 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 2 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 56 | 0 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 40 | 1 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 0 Participants |
| Tramadol | Number of Participants With Confirmed Orthostatic Hypotension | Week 64 | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
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.
Time frame: Baseline up to Week 80
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 11 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 40 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 39 Participants |
| Tramadol | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 45 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
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.
Time frame: Baseline up to Week 80
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 16 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 56 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 61 Participants |
| Tramadol | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 59 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Baseline up to Week 80
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 125 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 7 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 21 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 319 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 347 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 37 Participants |
| Tramadol | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 421 Participants |
| Tramadol | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 25 Participants |
Secondary
Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56
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.
Time frame: Baseline up to Week 56
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56 | AEs | 105 Participants |
| Placebo | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56 | SAEs | 1 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56 | AEs | 119 Participants |
| Pooled Tanezumab 5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56 | SAEs | 4 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56 | AEs | 200 Participants |
| Pooled Tanezumab 10 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56 | SAEs | 1 Participants |
Secondary
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?
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.
Time frame: Weeks 16 and 56
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 | 62 Participants |
| Pooled Tanezumab 5 mg | 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 | 66 Participants |
| Pooled Tanezumab 5 mg | 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 | 14 Participants |
| Pooled Tanezumab 5 mg | 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 | 19 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 172 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | 104 Participants |
| Pooled Tanezumab 10 mg | 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 | 36 Participants |
| Pooled Tanezumab 10 mg | 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 | 12 Participants |
| Pooled Tanezumab 10 mg | 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 | 4 Participants |
| Pooled Tanezumab 10 mg | 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 | 3 Participants |
| Pooled Tanezumab 10 mg | 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 | 191 Participants |
| Pooled Tanezumab 10 mg | 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 | 55 Participants |
| Pooled Tanezumab 10 mg | 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 | 23 Participants |
| Pooled Tanezumab 10 mg | 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 | 50 Participants |
| Pooled Tanezumab 10 mg | 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 | 21 Participants |
| Tramadol | 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 | 89 Participants |
| Tramadol | 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 | 42 Participants |
| Tramadol | 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 | 232 Participants |
| Tramadol | 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 | 129 Participants |
| Tramadol | 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 | 22 Participants |
| Tramadol | 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 | 30 Participants |
| Tramadol | 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 | 7 Participants |
| Tramadol | 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 | 17 Participants |
| Tramadol | 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 | 82 Participants |
| Tramadol | 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 | 6 Participants |
Secondary
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?
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.
Time frame: Weeks 16 and 56
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 | 21 Participants |
| Pooled Tanezumab 5 mg | 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 | 211 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 9 Participants |
| Pooled Tanezumab 5 mg | 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 | 90 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | 22 Participants |
| Pooled Tanezumab 10 mg | 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 | 10 Participants |
| Pooled Tanezumab 10 mg | 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 | 78 Participants |
| Pooled Tanezumab 10 mg | 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 | 0 Participants |
| Pooled Tanezumab 10 mg | 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 | 40 Participants |
| Pooled Tanezumab 10 mg | 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 | 13 Participants |
| Pooled Tanezumab 10 mg | 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 | 229 Participants |
| Pooled Tanezumab 10 mg | 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 | 4 Participants |
| Pooled Tanezumab 10 mg | 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 | 1 Participants |
| Pooled Tanezumab 10 mg | 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 | 102 Participants |
| Tramadol | 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 | 9 Participants |
| Tramadol | 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 | 44 Participants |
| Tramadol | 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 | 3 Participants |
| Tramadol | 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 | 147 Participants |
| Tramadol | 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 | 14 Participants |
| Tramadol | 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 | 39 Participants |
| Tramadol | 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 | 3 Participants |
| Tramadol | 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 | 109 Participants |
| Tramadol | 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 | 287 Participants |
| Tramadol | 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 | 1 Participants |
Secondary
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?
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.
Time frame: Weeks 16 and 56
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 10 Participants |
| Pooled Tanezumab 5 mg | 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 | 16 Participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 80 Participants |
| Pooled Tanezumab 5 mg | 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 | 36 Participants |
| Pooled Tanezumab 5 mg | 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 | 191 Participants |
| Pooled Tanezumab 10 mg | 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 | 31 Participants |
| Pooled Tanezumab 10 mg | 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 | 10 Participants |
| Pooled Tanezumab 10 mg | 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 | 2 Participants |
| Pooled Tanezumab 10 mg | 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 | 2 Participants |
| Pooled Tanezumab 10 mg | 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 | 38 Participants |
| Pooled Tanezumab 10 mg | 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 | 13 Participants |
| Pooled Tanezumab 10 mg | 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 | 210 Participants |
| Pooled Tanezumab 10 mg | 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 | 21 Participants |
| Pooled Tanezumab 10 mg | 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 | 114 Participants |
| Pooled Tanezumab 10 mg | 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 | 58 Participants |
| Tramadol | 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 | 26 Participants |
| Tramadol | 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 | 98 Participants |
| Tramadol | 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 | 24 Participants |
| Tramadol | 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 | 2 Participants |
| Tramadol | 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 | 41 Participants |
| Tramadol | 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 | 64 Participants |
| Tramadol | 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 | 251 Participants |
| Tramadol | 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 | 13 Participants |
| Tramadol | 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 | 4 Participants |
| Tramadol | 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 | 133 Participants |
Secondary
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)
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.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 31.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 13.1 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 5.2 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 47.5 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 26.1 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 12.8 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 56.2 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 35.7 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 15.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 4.4 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 61.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 41.9 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 19.7 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 7.6 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 64.8 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 43.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 21.7 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 7.4 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | 44.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 11.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 7.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 14.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 65.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 53.0 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 46.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 25.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 31.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 6.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 44.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 62.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 48.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 26.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 27.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 10.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 7.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 57.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 27.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 46.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 11.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 25.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 9.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 53.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 53.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 17.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 3.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 30.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 59.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 26.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 40.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 53.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 21.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 4.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 1.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 28.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 66.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 47.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 5.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 45.3 percentage of participants |
| Tramadol | 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 | 31.9 percentage of participants |
| Tramadol | 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 | 19.3 percentage of participants |
| Tramadol | 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 | 11.2 percentage of participants |
| Tramadol | 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 | 22.5 percentage of participants |
| Tramadol | 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 | 8.3 percentage of participants |
| Tramadol | 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 | 6.1 percentage of participants |
| Tramadol | 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 | 24.1 percentage of participants |
| Tramadol | 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 | 7.6 percentage of participants |
| Tramadol | 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 | 7.3 percentage of participants |
| Tramadol | 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 | 57.9 percentage of participants |
| Tramadol | 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 | 28.6 percentage of participants |
| Tramadol | 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 | 23.3 percentage of participants |
| Tramadol | 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 | 39.7 percentage of participants |
| Tramadol | 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 | 42.8 percentage of participants |
| Tramadol | 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 | 48.6 percentage of participants |
| Tramadol | 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 | 38.2 percentage of participants |
| Tramadol | 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 | 20.2 percentage of participants |
| Tramadol | 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 | 14.2 percentage of participants |
| Tramadol | 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 | 38.7 percentage of participants |
| Tramadol | 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 | 9.1 percentage of participants |
| Tramadol | 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 | 6.3 percentage of participants |
| Tramadol | 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 | 23.0 percentage of participants |
| Tramadol | 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 | 49.4 percentage of participants |
| Tramadol | 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 | 53.6 percentage of participants |
| Tramadol | 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 | 38.7 percentage of participants |
| Tramadol | 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 | 0.8 percentage of participants |
| Tramadol | 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 | 41.2 percentage of participants |
| Tramadol | 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 | 2.5 percentage of participants |
| Tramadol | 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 | 9.3 percentage of participants |
| Tramadol | 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 | 23.8 percentage of participants |
| Tramadol | 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 | 46.8 percentage of participants |
| Tramadol | 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 | 56.7 percentage of participants |
| Tramadol | 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 | 6.6 percentage of participants |
| Tramadol | 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 | 23.5 percentage of participants |
| Tramadol | 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 | 51.2 percentage of participants |
| Tramadol | 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 | 50.6 percentage of participants |
| Tramadol | 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 | 42.1 percentage of participants |
| Tramadol | 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 | 3.8 percentage of participants |
| Tramadol | 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 | 39.7 percentage of participants |
| Tramadol | 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 | 3.3 percentage of participants |
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.207695% CI: [0.91, 1.55]Regression, Logistic
Comparison: Week 2, \>=30%: Odds ratio (OR) and 95% Confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.000795% CI: [1.26, 2.39]Regression, Logistic
Comparison: Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.000495% CI: [1.29, 2.44]Regression, Logistic
Comparison: Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.345695% CI: [0.87, 1.5]Regression, Logistic
Comparison: Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.277195% CI: [0.89, 1.53]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.059495% CI: [0.98, 2.41]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.010595% CI: [1.14, 2.75]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.23695% CI: [0.85, 1.98]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.374695% CI: [0.81, 1.75]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.097495% CI: [0.94, 1.99]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.080695% CI: [0.92, 4.08]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.040795% CI: [1.03, 4.47]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.596695% CI: [0.58, 2.58]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.149295% CI: [0.85, 2.96]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.07295% CI: [0.95, 3.24]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.992695% CI: [0.25, 4]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.372695% CI: [0.51, 6.04]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.787495% CI: [0.22, 3.12]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.79595% CI: [0.32, 4.46]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.206595% CI: [0.66, 6.68]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.000695% CI: [1.23, 2.17]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: <0.000195% CI: [1.55, 2.72]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.038795% CI: [1.01, 1.71]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.090395% CI: [0.97, 1.6]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.000695% CI: [1.21, 2.01]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.016695% CI: [1.08, 2.09]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.000195% CI: [1.36, 2.62]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.138995% CI: [0.93, 1.73]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.250495% CI: [0.89, 1.59]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.005795% CI: [1.12, 1.98]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.012695% CI: [1.14, 2.93]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: <0.000195% CI: [1.71, 4.22]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.348595% CI: [0.79, 1.99]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.064295% CI: [0.98, 2.19]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: <0.000195% CI: [1.48, 3.14]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.981995% CI: [0.42, 2.31]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.433395% CI: [0.62, 3.02]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.81495% CI: [0.41, 2]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.833195% CI: [0.49, 2.4]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.268295% CI: [0.73, 3.12]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.000195% CI: [1.31, 2.29]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: <0.000195% CI: [1.49, 2.61]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.007195% CI: [1.1, 1.83]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.118795% CI: [0.95, 1.57]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.01195% CI: [1.08, 1.79]Regression, Logistic
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.000395% CI: [1.3, 2.39]Regression, Logistic
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: <0.000195% CI: [1.57, 2.87]Regression, Logistic
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.006995% CI: [1.11, 1.97]Regression, Logistic
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.007295% CI: [1.1, 1.86]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.069495% CI: [0.97, 2.22]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: <0.000195% CI: [1.53, 3.36]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.12195% CI: [0.92, 2]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.670695% CI: [0.76, 1.54]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.002295% CI: [1.2, 2.32]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.754695% CI: [0.56, 2.22]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.734795% CI: [0.57, 2.24]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.902995% CI: [0.5, 1.84]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.640295% CI: [0.62, 2.18]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.619995% CI: [0.62, 2.2]Regression, Logistic
Comparison: Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.022995% CI: [1.05, 1.83]Regression, Logistic
Comparison: Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.000295% CI: [1.3, 2.3]Regression, Logistic
Comparison: Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.31595% CI: [0.88, 1.47]Regression, Logistic
Comparison: Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.13795% CI: [0.94, 1.57]Regression, Logistic
Comparison: Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.001895% CI: [1.17, 1.97]Regression, Logistic
Comparison: Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.034295% CI: [1.02, 1.81]Regression, Logistic
Comparison: Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.000395% CI: [1.27, 2.24]Regression, Logistic
Comparison: Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.256195% CI: [0.9, 1.51]Regression, Logistic
Comparison: Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.235895% CI: [0.9, 1.51]Regression, Logistic
Comparison: Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.00495% CI: [1.13, 1.87]Regression, Logistic
Comparison: Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.072395% CI: [0.97, 2.02]Regression, Logistic
Comparison: Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: <0.000195% CI: [1.45, 2.92]Regression, Logistic
Comparison: Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.065395% CI: [0.98, 1.94]Regression, Logistic
Comparison: Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.917795% CI: [0.74, 1.4]Regression, Logistic
Comparison: Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.008895% CI: [1.11, 2.01]Regression, Logistic
Comparison: Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.119795% CI: [0.89, 2.83]Regression, Logistic
Comparison: Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.091395% CI: [0.92, 2.92]Regression, Logistic
Comparison: Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.431795% CI: [0.72, 2.19]Regression, Logistic
Comparison: Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.349895% CI: [0.77, 2.08]Regression, Logistic
Comparison: Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.276895% CI: [0.8, 2.15]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.010195% CI: [1.09, 1.92]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.005495% CI: [1.13, 1.99]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.549395% CI: [0.84, 1.39]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.026995% CI: [1.03, 1.74]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.014495% CI: [1.07, 1.8]Regression, Logistic
Comparison: Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.084695% CI: [0.97, 1.7]Regression, Logistic
Comparison: Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.010195% CI: [1.09, 1.91]Regression, Logistic
Comparison: Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.084895% CI: [0.97, 1.62]Regression, Logistic
Comparison: Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.873295% CI: [0.79, 1.32]Regression, Logistic
Comparison: Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.273495% CI: [0.89, 1.48]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.283995% CI: [0.86, 1.7]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.023895% CI: [1.05, 2.07]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.521295% CI: [0.81, 1.53]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.595495% CI: [0.8, 1.48]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.063895% CI: [0.98, 1.79]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.266195% CI: [0.78, 2.44]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.471795% CI: [0.69, 2.21]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.579895% CI: [0.68, 2]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.502795% CI: [0.72, 1.95]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.816595% CI: [0.64, 1.77]Regression, Logistic
Comparison: Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.199695% CI: [0.92, 1.52]Regression, Logistic
Comparison: Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.007495% CI: [1.1, 1.83]Regression, Logistic
Comparison: Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.355795% CI: [0.87, 1.45]Regression, Logistic
Comparison: Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.01795% CI: [1.06, 1.75]Regression, Logistic
Comparison: Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.864195% CI: [0.76, 1.38]Regression, Logistic
Comparison: Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.176895% CI: [0.91, 1.62]Regression, Logistic
Comparison: Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.769695% CI: [0.55, 1.55]Regression, Logistic
Comparison: Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.743395% CI: [0.66, 1.78]Regression, Logistic
Comparison: Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.056295% CI: [0.99, 1.65]Regression, Logistic
Comparison: Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.027495% CI: [1.03, 1.71]Regression, Logistic
Comparison: Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.120695% CI: [0.95, 1.58]Regression, Logistic
Comparison: Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.036595% CI: [1.02, 1.69]Regression, Logistic
Comparison: Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.096495% CI: [0.96, 1.71]Regression, Logistic
Comparison: Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.251595% CI: [0.89, 1.59]Regression, Logistic
Comparison: Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.812295% CI: [0.66, 1.71]Regression, Logistic
Comparison: Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.184895% CI: [0.86, 2.13]Regression, Logistic
Comparison: Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.262295% CI: [0.9, 1.49]Regression, Logistic
Comparison: Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.157995% CI: [0.93, 1.54]Regression, Logistic
Comparison: Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.277395% CI: [0.89, 1.49]Regression, Logistic
Comparison: Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.103295% CI: [0.96, 1.59]Regression, Logistic
Comparison: Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.441895% CI: [0.84, 1.5]Regression, Logistic
Comparison: Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.160895% CI: [0.92, 1.63]Regression, Logistic
Comparison: Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.262895% CI: [0.83, 2.02]Regression, Logistic
Comparison: Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.044795% CI: [1.01, 2.39]Regression, Logistic
Comparison: Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.25695% CI: [0.9, 1.49]Regression, Logistic
Comparison: Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.174195% CI: [0.93, 1.53]Regression, Logistic
Comparison: Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.164795% CI: [0.93, 1.55]Regression, Logistic
Comparison: Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.061995% CI: [0.99, 1.65]Regression, Logistic
Comparison: Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.202595% CI: [0.9, 1.61]Regression, Logistic
Comparison: Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.260195% CI: [0.88, 1.58]Regression, Logistic
Comparison: Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.563595% CI: [0.73, 1.77]Regression, Logistic
Comparison: Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.133895% CI: [0.91, 2.11]Regression, Logistic
Comparison: Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.213795% CI: [0.91, 1.51]Regression, Logistic
Comparison: Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.025695% CI: [1.04, 1.72]Regression, Logistic
Comparison: Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.353195% CI: [0.87, 1.46]Regression, Logistic
Comparison: Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.035895% CI: [1.02, 1.7]Regression, Logistic
Comparison: Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.18495% CI: [0.91, 1.62]Regression, Logistic
Comparison: Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.12595% CI: [0.94, 1.67]Regression, Logistic
Comparison: Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.826695% CI: [0.61, 1.48]Regression, Logistic
Comparison: Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.p-value: 0.567395% CI: [0.74, 1.72]Regression, Logistic
Secondary
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)
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 27.4 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 20.2 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 11.1 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 20.5 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | 14.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 30.0 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 23.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 22.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 21.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 21.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 24.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 25.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 22.4 percentage of participants |
| Tramadol | 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 | 20.7 percentage of participants |
| Tramadol | 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 | 18.8 percentage of participants |
| Tramadol | 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 | 22.5 percentage of participants |
| Tramadol | 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 | 20.5 percentage of participants |
| Tramadol | 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 | 21.5 percentage of participants |
| Tramadol | 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 | 10.1 percentage of participants |
| Tramadol | 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 | 20.7 percentage of participants |
| Tramadol | 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 | 15.0 percentage of participants |
| Tramadol | 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 | 20.5 percentage of participants |
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.32695% CI: [0.78, 2.08]Regression, Logistic
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.044595% CI: [1.01, 2.56]Regression, Logistic
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.926395% CI: [0.65, 1.61]Regression, Logistic
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.319495% CI: [0.81, 1.94]Regression, Logistic
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.030895% CI: [1.04, 2.38]Regression, Logistic
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.004895% CI: [1.2, 2.69]Regression, Logistic
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.011495% CI: [1.12, 2.51]Regression, Logistic
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.785795% CI: [0.71, 1.56]Regression, Logistic
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.004195% CI: [1.18, 2.44]Regression, Logistic
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.010995% CI: [1.11, 2.28]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.036395% CI: [1.03, 2.27]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.00495% CI: [1.2, 2.59]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.199295% CI: [0.88, 1.84]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.308495% CI: [0.85, 1.7]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.058695% CI: [0.99, 1.94]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.06395% CI: [0.98, 1.97]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.034795% CI: [1.03, 2.04]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.7995% CI: [0.69, 1.33]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.020795% CI: [1.06, 2]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.009395% CI: [1.11, 2.07]Regression, Logistic
Comparison: Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.0495% CI: [1.02, 1.91]Regression, Logistic
Comparison: Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.247895% CI: [0.88, 1.65]Regression, Logistic
Comparison: Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.030495% CI: [1.03, 1.96]Regression, Logistic
Comparison: Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.476395% CI: [0.81, 1.56]Regression, Logistic
Comparison: Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.017895% CI: [1.07, 2.01]Regression, Logistic
Comparison: Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.522395% CI: [0.8, 1.53]Regression, Logistic
Comparison: Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.170895% CI: [0.91, 1.72]Regression, Logistic
Comparison: Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.602295% CI: [0.79, 1.5]Regression, Logistic
Comparison: Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.084695% CI: [0.96, 1.81]Regression, Logistic
Comparison: Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.p-value: 0.962695% CI: [0.73, 1.39]Regression, Logistic
Secondary
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)
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 | 32.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 20.0 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 10.6 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 4.2 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 46.2 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 30.9 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 17.5 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 7.9 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 52.8 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 36.8 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 23.2 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 12.1 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 58.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 46.7 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 32.1 percentage of participants |
| Pooled Tanezumab 5 mg | 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 | 17.0 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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 | 37.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 15.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 56.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 18.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 45.0 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 40.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 46.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 48.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 29.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 13.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 38.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 44.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 31.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 17.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 48.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 62.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 38.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 9.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 40.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 21.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 21.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 17.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 28.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 10.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 18.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 49.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 29.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 5.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 34.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 31.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 17.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 50.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 24.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 53.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 45.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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 | 34.2 percentage of participants |
| Tramadol | 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 | 41.5 percentage of participants |
| Tramadol | 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 | 40.8 percentage of participants |
| Tramadol | 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 | 10.9 percentage of participants |
| Tramadol | 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 | 43.0 percentage of participants |
| Tramadol | 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 | 22.3 percentage of participants |
| Tramadol | 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 | 3.1 percentage of participants |
| Tramadol | 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 | 48.6 percentage of participants |
| Tramadol | 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 | 33.2 percentage of participants |
| Tramadol | 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 | 33.4 percentage of participants |
| Tramadol | 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 | 41.5 percentage of participants |
| Tramadol | 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 | 16.4 percentage of participants |
| Tramadol | 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 | 20.7 percentage of participants |
| Tramadol | 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 | 6.4 percentage of participants |
| Tramadol | 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 | 52.2 percentage of participants |
| Tramadol | 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 | 34.0 percentage of participants |
| Tramadol | 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 | 11.4 percentage of participants |
| Tramadol | 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 | 38.7 percentage of participants |
| Tramadol | 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 | 44.8 percentage of participants |
| Tramadol | 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 | 22.3 percentage of participants |
| Tramadol | 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 | 22.0 percentage of participants |
| Tramadol | 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 | 8.6 percentage of participants |
| Tramadol | 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 | 34.4 percentage of participants |
| Tramadol | 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 | 23.3 percentage of participants |
| Tramadol | 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 | 11.4 percentage of participants |
| Tramadol | 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 | 8.3 percentage of participants |
| Tramadol | 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 | 32.2 percentage of participants |
| Tramadol | 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 | 11.7 percentage of participants |
| Tramadol | 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 | 29.3 percentage of participants |
| Tramadol | 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 | 11.6 percentage of participants |
| Tramadol | 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 | 16.9 percentage of participants |
| Tramadol | 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 | 6.6 percentage of participants |
| Tramadol | 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 | 22.5 percentage of participants |
| Tramadol | 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 | 25.3 percentage of participants |
| Tramadol | 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 | 2.3 percentage of participants |
| Tramadol | 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 | 39.7 percentage of participants |
| Tramadol | 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 | 35.9 percentage of participants |
Comparison: Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.007695% CI: [1.12, 2.08]Regression, Logistic
Comparison: Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.46, 2.69]Regression, Logistic
Comparison: Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.0795% CI: [0.98, 1.74]Regression, Logistic
Comparison: Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.265595% CI: [0.89, 1.54]Regression, Logistic
Comparison: Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.002295% CI: [1.16, 1.98]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.012595% CI: [1.11, 2.35]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.003295% CI: [1.21, 2.54]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.152895% CI: [0.91, 1.85]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.186395% CI: [0.9, 1.72]Regression, Logistic
Comparison: Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.066795% CI: [0.98, 1.86]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.010195% CI: [1.18, 3.39]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.016295% CI: [1.13, 3.25]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.559995% CI: [0.69, 1.99]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.020295% CI: [1.09, 2.68]Regression, Logistic
Comparison: Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.033595% CI: [1.04, 2.57]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.041695% CI: [1.04, 6.17]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.007595% CI: [1.37, 7.69]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.537495% CI: [0.53, 3.34]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.08295% CI: [0.92, 3.89]Regression, Logistic
Comparison: Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.010895% CI: [1.23, 4.81]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000695% CI: [1.24, 2.2]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.47, 2.59]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.096395% CI: [0.96, 1.63]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.033295% CI: [1.02, 1.71]Regression, Logistic
Comparison: Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000795% CI: [1.21, 2.01]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000195% CI: [1.37, 2.64]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.6, 3.05]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.023595% CI: [1.05, 1.95]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.045995% CI: [1.01, 1.76]Regression, Logistic
Comparison: Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.00295% CI: [1.17, 2.04]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.001995% CI: [1.27, 2.91]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.62, 3.62]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.676595% CI: [0.72, 1.65]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.002295% CI: [1.23, 2.54]Regression, Logistic
Comparison: Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.56, 3.15]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.02795% CI: [1.08, 3.63]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.00395% CI: [1.35, 4.38]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.37795% CI: [0.38, 1.44]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000995% CI: [1.49, 4.79]Regression, Logistic
Comparison: Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.87, 5.78]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.001195% CI: [1.2, 2.1]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.41, 2.47]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.027395% CI: [1.03, 1.72]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.173695% CI: [0.93, 1.54]Regression, Logistic
Comparison: Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.009295% CI: [1.09, 1.81]Regression, Logistic
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.001595% CI: [1.2, 2.2]Regression, Logistic
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.45, 2.63]Regression, Logistic
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.016495% CI: [1.06, 1.86]Regression, Logistic
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.285795% CI: [0.89, 1.51]Regression, Logistic
Comparison: Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.014995% CI: [1.07, 1.8]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000195% CI: [1.43, 3.02]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.57, 3.28]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.11895% CI: [0.93, 1.92]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.006295% CI: [1.13, 2.14]Regression, Logistic
Comparison: Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000995% CI: [1.24, 2.32]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000395% CI: [1.56, 4.61]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.82, 5.28]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.31295% CI: [0.76, 2.32]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.001995% CI: [1.3, 3.14]Regression, Logistic
Comparison: Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000195% CI: [1.52, 3.59]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.006495% CI: [1.12, 1.95]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000195% CI: [1.32, 2.31]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.275795% CI: [0.89, 1.48]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.057595% CI: [0.99, 1.65]Regression, Logistic
Comparison: Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.001595% CI: [1.17, 1.96]Regression, Logistic
Comparison: Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000795% CI: [1.23, 2.16]Regression, Logistic
Comparison: Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000195% CI: [1.31, 2.31]Regression, Logistic
Comparison: Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.012495% CI: [1.07, 1.79]Regression, Logistic
Comparison: Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.002595% CI: [1.15, 1.91]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000295% CI: [1.33, 2.51]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.48, 2.79]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.570195% CI: [0.8, 1.49]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000495% CI: [1.26, 2.22]Regression, Logistic
Comparison: Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.4, 2.46]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000895% CI: [1.35, 3.17]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.005995% CI: [1.19, 2.83]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.774195% CI: [0.6, 1.46]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.5, 3.25]Regression, Logistic
Comparison: Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000895% CI: [1.32, 2.9]Regression, Logistic
Comparison: Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.08995% CI: [0.97, 1.6]Regression, Logistic
Comparison: Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.006795% CI: [1.1, 1.83]Regression, Logistic
Comparison: Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.007295% CI: [1.1, 1.85]Regression, Logistic
Comparison: Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000495% CI: [1.23, 2.06]Regression, Logistic
Comparison: Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.001395% CI: [1.2, 2.15]Regression, Logistic
Comparison: Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.34, 2.39]Regression, Logistic
Comparison: Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.51, 3.3]Regression, Logistic
Comparison: Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: <0.000195% CI: [1.72, 3.71]Regression, Logistic
Comparison: Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.073295% CI: [0.98, 1.62]Regression, Logistic
Comparison: Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.039995% CI: [1.01, 1.68]Regression, Logistic
Comparison: Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.053695% CI: [1, 1.67]Regression, Logistic
Comparison: Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.004395% CI: [1.12, 1.88]Regression, Logistic
Comparison: Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.014395% CI: [1.07, 1.91]Regression, Logistic
Comparison: Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.000795% CI: [1.23, 2.16]Regression, Logistic
Comparison: Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.00595% CI: [1.17, 2.38]Regression, Logistic
Comparison: Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.004395% CI: [1.18, 2.4]Regression, Logistic
Comparison: Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.277795% CI: [0.89, 1.48]Regression, Logistic
Comparison: Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.032695% CI: [1.02, 1.7]Regression, Logistic
Comparison: Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.182395% CI: [0.92, 1.55]Regression, Logistic
Comparison: Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.03595% CI: [1.02, 1.71]Regression, Logistic
Comparison: Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.016495% CI: [1.07, 1.88]Regression, Logistic
Comparison: Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.025795% CI: [1.04, 1.84]Regression, Logistic
Comparison: Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.00795% CI: [1.14, 2.35]Regression, Logistic
Comparison: Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.008595% CI: [1.13, 2.32]Regression, Logistic
Comparison: Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.492595% CI: [0.85, 1.41]Regression, Logistic
Comparison: Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.153495% CI: [0.93, 1.55]Regression, Logistic
Comparison: Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.120295% CI: [0.95, 1.6]Regression, Logistic
Comparison: Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.122295% CI: [0.95, 1.6]Regression, Logistic
Comparison: Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.017995% CI: [1.06, 1.9]Regression, Logistic
Comparison: Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.006595% CI: [1.12, 1.99]Regression, Logistic
Comparison: Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.022395% CI: [1.06, 2.2]Regression, Logistic
Comparison: Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.004595% CI: [1.17, 2.4]Regression, Logistic
Comparison: Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.938595% CI: [0.77, 1.28]Regression, Logistic
Comparison: Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.109395% CI: [0.95, 1.59]Regression, Logistic
Comparison: Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.163195% CI: [0.93, 1.57]Regression, Logistic
Comparison: Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.028595% CI: [1.03, 1.74]Regression, Logistic
Comparison: Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.038995% CI: [1.02, 1.81]Regression, Logistic
Comparison: Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.02495% CI: [1.04, 1.86]Regression, Logistic
Comparison: Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.006395% CI: [1.15, 2.34]Regression, Logistic
Comparison: Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.p-value: 0.002195% CI: [1.22, 2.47]Regression, Logistic
Secondary
Percentage of Participants With Adjudicated Joint Safety Outcomes
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.
Time frame: Baseline up to Week 80
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Composite Joint Safety Endpoint | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Subchondral Insufficiency Fracture | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 2 | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Primary Osteonecrosis | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Pathological Fracture | 0 percentage of participants |
| Pooled Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Subchondral Insufficiency Fracture | 0 percentage of participants |
| Pooled Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 1.0 percentage of participants |
| Pooled Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Pathological Fracture | 0 percentage of participants |
| Pooled Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA | 1.0 percentage of participants |
| Pooled Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Primary Osteonecrosis | 0 percentage of participants |
| Pooled Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 2 | 0 percentage of participants |
| Pooled Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Composite Joint Safety Endpoint | 1.0 percentage of participants |
| Pooled Tanezumab 10 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 2 | 0.4 percentage of participants |
| Pooled Tanezumab 10 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Composite Joint Safety Endpoint | 2.6 percentage of participants |
| Pooled Tanezumab 10 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Pathological Fracture | 0 percentage of participants |
| Pooled Tanezumab 10 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Primary Osteonecrosis | 0 percentage of participants |
| Pooled Tanezumab 10 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 1.4 percentage of participants |
| Pooled Tanezumab 10 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Subchondral Insufficiency Fracture | 0.8 percentage of participants |
| Pooled Tanezumab 10 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA | 1.8 percentage of participants |
| Tramadol | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 0.2 percentage of participants |
| Tramadol | Percentage of Participants With Adjudicated Joint Safety Outcomes | Subchondral Insufficiency Fracture | 0 percentage of participants |
| Tramadol | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA | 0.2 percentage of participants |
| Tramadol | Percentage of Participants With Adjudicated Joint Safety Outcomes | Pathological Fracture | 0 percentage of participants |
| Tramadol | Percentage of Participants With Adjudicated Joint Safety Outcomes | Primary Osteonecrosis | 0 percentage of participants |
| Tramadol | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 2 | 0 percentage of participants |
| Tramadol | Percentage of Participants With Adjudicated Joint Safety Outcomes | Composite Joint Safety Endpoint | 0.2 percentage of participants |
Secondary
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)
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.
Time frame: Baseline, Weeks 16, 24 and 56
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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% | 72.5 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 7.4 percentage of participants |
| Pooled Tanezumab 5 mg | 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% | 43.2 percentage of participants |
| Pooled Tanezumab 5 mg | 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% | 3.9 percentage of participants |
| Pooled Tanezumab 5 mg | 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% | 79.1 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 33.4 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 85.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 21.6 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 64.6 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 13.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 52.1 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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% | 53.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 36.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 25.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 15.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 6.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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 |
| Pooled Tanezumab 10 mg | 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% | 72.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 69.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 64.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 62.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 55.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 48.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 37.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 27.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 15.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 7.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 5.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 61.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 58.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 55.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 50.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 45.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 36.0 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 27.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 19.0 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 10.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 7.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 73.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 87.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 82.1 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 46.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 65.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 56.3 percentage of participants |
| Tramadol | 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% | 74.5 percentage of participants |
| Tramadol | 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% | 31.1 percentage of participants |
| Tramadol | 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% | 32.2 percentage of participants |
| Tramadol | 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% | 6.3 percentage of participants |
| Tramadol | 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% | 23.3 percentage of participants |
| Tramadol | 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% | 41.2 percentage of participants |
| Tramadol | 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% | 13.4 percentage of participants |
| Tramadol | 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% | 15.5 percentage of participants |
| Tramadol | 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% | 47.8 percentage of participants |
| Tramadol | 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% | 57.9 percentage of participants |
| Tramadol | 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% | 9.3 percentage of participants |
| Tramadol | 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% | 53.6 percentage of participants |
| Tramadol | 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% | 42.8 percentage of participants |
| Tramadol | 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% | 6.1 percentage of participants |
| Tramadol | 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% | 20.2 percentage of participants |
| Tramadol | 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 |
| Tramadol | 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% | 58.0 percentage of participants |
| Tramadol | 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% | 63.1 percentage of participants |
| Tramadol | 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% | 49.9 percentage of participants |
| Tramadol | 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% | 55.7 percentage of participants |
| Tramadol | 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% | 58.2 percentage of participants |
| Tramadol | 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% | 66.4 percentage of participants |
| Tramadol | 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% | 51.2 percentage of participants |
| Tramadol | 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% | 3.8 percentage of participants |
| Tramadol | 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 |
| Tramadol | 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% | 46.8 percentage of participants |
| Tramadol | 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% | 6.6 percentage of participants |
| Tramadol | 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% | 4.1 percentage of participants |
| Tramadol | 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% | 42.1 percentage of participants |
| Tramadol | 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% | 14.2 percentage of participants |
| Tramadol | 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% | 32.2 percentage of participants |
| Tramadol | 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% | 38.7 percentage of participants |
| Tramadol | 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% | 23.8 percentage of participants |
Secondary
Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
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.
Time frame: Baseline, Weeks 16, 24 and 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 53.1 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 72.6 percentage of participants |
| Pooled Tanezumab 5 mg | 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% | 46.7 percentage of participants |
| Pooled Tanezumab 5 mg | 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% | 76.8 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 38.0 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 32.1 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 23.2 percentage of participants |
| Pooled Tanezumab 5 mg | 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% | 65.4 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 17.0 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 13.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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% | 58.3 percentage of participants |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 10 mg | 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% | 33.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 83.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 78.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 70.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 62.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 53.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 48.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 41.0 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 34.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 26.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 15.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 9.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 64.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 61.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 56.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 53.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 48.2 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 45.0 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 38.6 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 31.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 25.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 18.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 11.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 56.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 54.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 50.9 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 46.4 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 42.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 38.8 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 28.5 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 24.3 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 18.7 percentage of participants |
| Pooled Tanezumab 10 mg | 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% | 14.0 percentage of participants |
| Tramadol | 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% | 57.7 percentage of participants |
| Tramadol | 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% | 22.3 percentage of participants |
| Tramadol | 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% | 52.6 percentage of participants |
| Tramadol | 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% | 4.8 percentage of participants |
| Tramadol | 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% | 59.3 percentage of participants |
| Tramadol | 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% | 49.9 percentage of participants |
| Tramadol | 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% | 8.6 percentage of participants |
| Tramadol | 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 |
| Tramadol | 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% | 46.0 percentage of participants |
| Tramadol | 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% | 15.5 percentage of participants |
| Tramadol | 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% | 17.2 percentage of participants |
| Tramadol | 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% | 41.5 percentage of participants |
| Tramadol | 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% | 22.3 percentage of participants |
| Tramadol | 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% | 66.3 percentage of participants |
| Tramadol | 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% | 36.2 percentage of participants |
| Tramadol | 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% | 30.9 percentage of participants |
| Tramadol | 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% | 7.4 percentage of participants |
| Tramadol | 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% | 32.2 percentage of participants |
| Tramadol | 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% | 34.0 percentage of participants |
| Tramadol | 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% | 38.7 percentage of participants |
| Tramadol | 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% | 26.1 percentage of participants |
| Tramadol | 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% | 39.5 percentage of participants |
| Tramadol | 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% | 44.3 percentage of participants |
| Tramadol | 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% | 20.7 percentage of participants |
| Tramadol | 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% | 44.8 percentage of participants |
| Tramadol | 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% | 27.1 percentage of participants |
| Tramadol | 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% | 14.2 percentage of participants |
| Tramadol | 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% | 51.1 percentage of participants |
| Tramadol | 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% | 52.2 percentage of participants |
| Tramadol | 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% | 8.3 percentage of participants |
| Tramadol | 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% | 55.7 percentage of participants |
| Tramadol | 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% | 11.7 percentage of participants |
| Tramadol | 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% | 5.6 percentage of participants |
Secondary
Percentage of Participants With Total Joint Replacements
Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery.
Time frame: Baseline up to Week 80
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Total Joint Replacements | 0 percentage of participants |
| Pooled Tanezumab 5 mg | Percentage of Participants With Total Joint Replacements | 0 percentage of participants |
| Pooled Tanezumab 10 mg | Percentage of Participants With Total Joint Replacements | 1.4 percentage of participants |
| Tramadol | Percentage of Participants With Total Joint Replacements | 0 percentage of participants |
Secondary
Time to Discontinuation Due to Lack of Efficacy
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.
Time frame: Baseline up to Week 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Pooled Tanezumab 5 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Pooled Tanezumab 10 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tramadol | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tramadol | Time to Discontinuation Due to Lack of Efficacy | NA days |
Comparison: Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.p-value: 0.4724Log Rank
Comparison: Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.p-value: 0.7142Log Rank
Secondary
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
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.
Time frame: Weeks 16 and 56
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 1.5 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Convenience | 75.68 units on a scale | Standard Error 1.16 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Side Effects | 79.26 units on a scale | Standard Error 3.31 |
| Pooled Tanezumab 5 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Global Satisfaction | 70.32 units on a scale | Standard Error 1.39 |
| Pooled Tanezumab 5 mg | 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 |
| Pooled Tanezumab 5 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Effectiveness | 63.69 units on a scale | Standard Error 1.48 |
| Pooled Tanezumab 10 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Side Effects | 79.51 units on a scale | Standard Error 3.31 |
| Pooled Tanezumab 10 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 56: Global Satisfaction | 78.49 units on a scale | Standard Error 1.73 |
| Pooled Tanezumab 10 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Convenience | 76.37 units on a scale | Standard Error 1.15 |
| Pooled Tanezumab 10 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 56: Convenience | 80.52 units on a scale | Standard Error 1.6 |
| Pooled Tanezumab 10 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Effectiveness | 62.87 units on a scale | Standard Error 1.48 |
| Pooled Tanezumab 10 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Global Satisfaction | 68.64 units on a scale | Standard Error 1.38 |
| Pooled Tanezumab 10 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 56: Effectiveness | 72.51 units on a scale | Standard Error 2.01 |
| Pooled Tanezumab 10 mg | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 56: Side Effects | 89.37 units on a scale | Standard Error 4.76 |
| Tramadol | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 56: Global Satisfaction | 74.57 units on a scale | Standard Error 1.55 |
| Tramadol | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Effectiveness | 61.39 units on a scale | Standard Error 1.3 |
| Tramadol | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Side Effects | 70.83 units on a scale | Standard Error 2.15 |
| Tramadol | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Global Satisfaction | 67.12 units on a scale | Standard Error 1.22 |
| Tramadol | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 16: Convenience | 74.63 units on a scale | Standard Error 1.04 |
| Tramadol | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 56: Convenience | 78.42 units on a scale | Standard Error 1.45 |
| Tramadol | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 56: Side Effects | 76.20 units on a scale | Standard Error 3.09 |
| Tramadol | Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 | Week 56: Effectiveness | 71.21 units on a scale | Standard Error 1.79 |
Comparison: TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.018795% CI: [0.54, 5.97]ANCOVA
Comparison: TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.000595% CI: [3.07, 10.97]ANCOVA
Comparison: TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.002195% CI: [2.26, 10.15]ANCOVA
Comparison: TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.012595% CI: [1.02, 8.42]ANCOVA
Comparison: TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.217695% CI: [-1.36, 5.97]ANCOVA
Comparison: TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.423595% CI: [-2.16, 5.14]ANCOVA
Comparison: TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.014395% CI: [2.5, 22.11]ANCOVA
Comparison: TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.012495% CI: [2.76, 22.35]ANCOVA
Comparison: TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.367595% CI: [-4.6, 12.36]ANCOVA
Comparison: TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.031995% CI: [0.74, 16.11]ANCOVA
Comparison: TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.027695% CI: [0.97, 16.38]ANCOVA
Comparison: TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.062795% CI: [-0.14, 5.27]ANCOVA
Comparison: TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.241995% CI: [-1.03, 4.06]ANCOVA
Comparison: TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.412495% CI: [-1.46, 3.56]ANCOVA
Comparison: TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.17395% CI: [-0.76, 4.24]ANCOVA
Comparison: TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.003795% CI: [1.77, 9.08]ANCOVA
Comparison: TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.044995% CI: [0.09, 7.39]ANCOVA
Comparison: TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.203895% CI: [-1.21, 5.65]ANCOVA
Comparison: TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.064495% CI: [-0.19, 6.59]ANCOVA
Comparison: TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.377595% CI: [-1.86, 4.9]ANCOVA
Comparison: TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.580695% CI: [-3.7, 6.6]ANCOVA
Comparison: TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.608495% CI: [-3.68, 6.27]ANCOVA
Comparison: TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.699195% CI: [-11.56, 16.99]ANCOVA
Comparison: TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.026595% CI: [1.66, 24.68]ANCOVA
Comparison: TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.879595% CI: [-3.61, 4.21]ANCOVA
Comparison: TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.275895% CI: [-1.68, 5.87]ANCOVA
Comparison: TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.119795% CI: [-0.92, 8]ANCOVA
Comparison: TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.p-value: 0.074395% CI: [-0.39, 8.24]ANCOVA
Secondary
Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Pooled Tanezumab 5 mg | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Work Time Missed | 11.1 units on a scale | Standard Deviation 21.03 |
| Pooled Tanezumab 5 mg | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Overall Work Impairment | 63.2 units on a scale | Standard Deviation 20.34 |
| Pooled Tanezumab 5 mg | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Impairment While Working | 60.8 units on a scale | Standard Deviation 19.68 |
| Pooled Tanezumab 5 mg | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Activity Impairment | 66.6 units on a scale | Standard Deviation 17.57 |
| Pooled Tanezumab 10 mg | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Impairment While Working | 60.6 units on a scale | Standard Deviation 20.56 |
| Pooled Tanezumab 10 mg | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Work Time Missed | 10.8 units on a scale | Standard Deviation 19.89 |
| Pooled Tanezumab 10 mg | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Overall Work Impairment | 63.1 units on a scale | Standard Deviation 21.69 |
| Pooled Tanezumab 10 mg | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Activity Impairment | 65.1 units on a scale | Standard Deviation 18.33 |
| Tramadol | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Activity Impairment | 65.4 units on a scale | Standard Deviation 18.31 |
| Tramadol | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Overall Work Impairment | 63.6 units on a scale | Standard Deviation 20.93 |
| Tramadol | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Impairment While Working | 61.2 units on a scale | Standard Deviation 19.83 |
| Tramadol | Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data | Percent Work Time Missed | 10.7 units on a scale | Standard Deviation 20.12 |