Chronic Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Brief summary
The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.
Interventions
DRUGNSAID
Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
BIOLOGICALTanezumab 2.5 mg
Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks
BIOLOGICALTanezumab 5 mg
Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader * Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period * WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening * Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study * Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements
Exclusion criteria
* Subjects exceeding protocol defined BMI or body weight limits * History of other diseases specified in the protocol (eg, inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments * Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer * A history of osteonecrosis or osteoporotic fracture * History of significant trauma or surgery to a knee, hip or shoulder within the previous year * Planned surgical procedure during the duration of the study * Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain * Signs or symptoms of carpal tunnel syndrome in the year prior to Screening * Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required * Contraindications to magnetic resonance imaging * History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or diclofenac) the subject could be randomized to receive or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of this NSAID is contraindicated * History of intolerance or hypersensitivity to acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated * Use of prohibited medications without the appropriate washout period prior to Screening or Initial Pain Assessment Period * History of cancer within 5 years of Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision * Subjects with signs and symptoms of clinically significant cardiac disease as described in the protocol * Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities * History, diagnosis, or signs and symptoms of clinically significant neurological disease such as but not limited to peripheral or autonomic neuropathy * History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder * History of known alcohol, analgesic or drug abuse within 2 years of Screening * Previous exposure to exogenous NGF or to an anti-NGF antibody * History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein * Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening * Evidence of protocol defined orthostatic hypotension at Screening * Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening * Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits * Presence of drugs of abuse in screening urine toxicology panel * Positive hepatitis B, hepatitis C or HIV test results indicative of current infection * Participation in other investigational drug studies within protocol defined time limits * Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome | Baseline up to Week 80 | Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to \[\>=\] 2 millimeters \[mm\]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA. |
| Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome | Baseline up to Week 80 | Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | Baseline, Week 16 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | Baseline, Week 16 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. |
| Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline, Week 16 | PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | Baseline up to Week 80 | Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk. |
| Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Baseline, Weeks 56 and 80 | Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 \[no radiographic features of OA\], 1 \[doubtful joint space narrowing (JSN) and possible osteophytic lipping\], 2 \[definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph\], 3 \[multiple osteophytes, definite JSN, sclerosis, possible bony deformity\], 4 \[large osteophytes, marked JSN, severe sclerosis and definite bony deformity\]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). |
| Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Baseline, Weeks 56 and 80 | Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function. |
| Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Weeks 56 and 80 | Progression of OA according to Bland-Altman as defined by a decrease JSW \>=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 \[no radiographic features of OA\], 1 \[doubtful joint space narrowing (JSN) and possible osteophytic lipping\], 2 \[definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph\], 3 \[multiple osteophytes, definite JSN, sclerosis, possible bony deformity\], 4 \[large osteophytes, marked JSN, severe sclerosis and definite bony deformity\]. Higher grade indicating worse knee function. |
| Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Weeks 56 and 80 | Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW \>=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function. |
| Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in WOMAC Pain Subscale at Week 64 | Baseline, Week 64 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. |
| Change From Baseline in WOMAC Physical Function Subscale at Week 64 | Baseline, Week 64 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. |
| Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
| Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 | Baseline, Week 64 | PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
| Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was \>=50 percent and \>= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and PGA of OA (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF). |
| Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Percentage of participants with reduction in WOMAC pain intensity of \>= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF. |
| Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Baseline, Weeks 16, 24 and 56 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than \[\>\] 0% ; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale 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. |
| Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized. |
| Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Percentage of participants with reduction in WOMAC physical function of \>=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF. |
| Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Baseline, Weeks 16, 24 and 56 | Percentage of participants with cumulative reduction (as percent) (\> 0 %; \>= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF. |
| Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF. |
| Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score. |
| Change From Baseline in Average Pain Score in the Index Joint at Week 64 | Baseline, Week 64 | Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score. |
| Number of Days of Rescue Medication Used During Week 64 | Week 64 | In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 were summarized. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 | Baseline, Week 64 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 | Baseline, Week 64 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Weeks 2, 4, 8 and 16 | In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64 | Baseline, Week 64 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64 | Baseline, Week 64 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Weeks 16, 24 and 56 | WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (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. |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline, Week 64 | WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (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. |
| Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline, Weeks 8, 16, 24, 40, 56 and 64 | Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. |
| Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline, Weeks 8, 16, 24, 40, 56 and 64 | Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. |
| Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline, Weeks 8, 16, 24, 40, 56 and 64 | Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. |
| Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline, Weeks 8, 16, 24, 40, 56 and 64 | Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. |
| Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline, Weeks 8, 16, 24, 40, 56 and 64 | Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. |
| European Quality of Life-5 Dimensions-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 two 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. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (\<=) 1. The 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 is reduced where a participant reports greater levels of problems across the five dimensions. |
| Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Weeks 16 and 56 | TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied\]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied\] and 1 question on 2 point scale \[0 =No, 1=Yes\]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction. |
| 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 Osteoarthritis Pain Before Enrolling? | Weeks 16 and 56 | The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent 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. Number of participants who responded for the specified question were reported. |
| 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 | The mPRTI is a self-administered questionnaire containing 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 preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the 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 the investigational product. Number of participants who responded for the specified question were reported. |
| 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 Osteoarthritis Pain? | Weeks 16 and 56 | The mPRTI is a self-administered questionnaire containing 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 participant willingness to use drug again, participants responded using IRT on a 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. Number of participants who responded for the specified question were reported. |
| 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, 16, 24, 32, 40, 48 and 56 | Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized. |
| Number of Participants Who Took Rescue Medication During Week 64 | Week 64 | In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 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 Week 64 were summarized. |
| Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline, Weeks 64 and 80 | OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA 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. |
| Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline, Weeks 64 and 80 | OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA. |
| Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline, Weeks 64 and 80 | Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA. |
| Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline, Weeks 64 and 80 | OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA. |
| Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Baseline, Weeks 64 and 80 | OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA. |
| Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline, Weeks 64 and 80 | OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). 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 Osteoarthritis | Baseline, Weeks 64 and 80 | OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA. |
| Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline, Weeks 64 and 80 | OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA. |
| Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Baseline, Weeks 4, 8, 16, 24, 56 and 80 | The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change \>0), No change and worsening (Change less than \[\<\] 0). |
| Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Baseline, Weeks 16 and 56 | Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose). |
| Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Baseline, Weeks 16 and 56 | An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose). |
| Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Baseline, Weeks 16 and 56 | An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {\<1500} counts moderate (1,500 - \<6500 counts), and vigorous (\>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose). |
| Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Baseline, Weeks 16 and 56 | An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - \<1,500 counts) moderate (1,500 - \<6,500 counts), and vigorous (\>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A bout of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold. |
| Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Baseline, Weeks 16 and 56 | Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose). |
| 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 pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs. |
| Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 80 | Treatment-related AE was any untoward medical occurrence attributed to study drug in a 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 Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. |
| 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; Leukocytes \<0.6\*LLN, \>1.5\*ULN; Lymphocytes, 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 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, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes \<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; specific gravity\<1.003, \>1.030; Urine erythrocytes,Leukocytes\>=20; Hyaline Casts\>=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). |
| 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 (pulse rate) was measured at sitting position. |
| Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome | Baseline up to Week 80 | Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA. |
| Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Baseline, Weeks 56 and 80 | Heart rate was measured at sitting position. |
| 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. |
| Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | 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. |
| 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. |
| Number of Participants With Anti-Tanezumab Antibodies | Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80 | Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). |
| Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | Baseline, Weeks 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 (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (\>) 30 millisecond (ms) or 60 ms; absolute value \> 450 ms, \>480 ms and \> 500 ms; 2) heart rate (HR) : absolute value \<=50 bpm and decrease from baseline \>=20 bpm; absolute value \>=120 beats per minute (bpm) and increase from baseline \>=20 bpm; 3) PR interval: absolute value \>=220 ms and increase from baseline \>=20 ms; 4) QRS interval: absolute value \>= 120 ms. |
| Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome | Baseline up to Week 80 | Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk. |
| Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Baseline up to Week 80 | Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW \>=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA. |
| Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Baseline up to Week 80 | Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk. |
| Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | Baseline up to Week 80 | Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. |
Countries
Australia, Brazil, Bulgaria, Colombia, Croatia, Japan, Lithuania, Mexico, New Zealand, Peru, Philippines, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56. | 1,002 |
| Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56. | 998 |
| NSAID Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48. | 996 |
| Total | 2,996 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 23 | 22 | 8 |
| Overall Study | Death | 4 | 4 | 0 |
| Overall Study | Lack of Efficacy | 19 | 21 | 22 |
| Overall Study | Lost to Follow-up | 25 | 21 | 31 |
| Overall Study | Other | 89 | 91 | 74 |
| Overall Study | Protocol Violation | 4 | 6 | 4 |
| Overall Study | Randomized but not treated | 6 | 7 | 12 |
| Overall Study | Withdrawal by Subject | 97 | 104 | 100 |
Baseline characteristics
| Characteristic | Tanezumab 2.5 mg | Tanezumab 5 mg | NSAID | Total |
|---|---|---|---|---|
| Age, Continuous | 60.30 years STANDARD_DEVIATION 9.17 | 61.15 years STANDARD_DEVIATION 9.57 | 60.25 years STANDARD_DEVIATION 9.46 | 60.57 years STANDARD_DEVIATION 9.41 |
| Race/Ethnicity, Customized Asian | 110 Participants | 95 Participants | 99 Participants | 304 Participants |
| Race/Ethnicity, Customized Black or African American | 166 Participants | 162 Participants | 186 Participants | 514 Participants |
| Race/Ethnicity, Customized Other | 21 Participants | 29 Participants | 31 Participants | 81 Participants |
| Race/Ethnicity, Customized White | 705 Participants | 712 Participants | 680 Participants | 2097 Participants |
| Sex: Female, Male Female | 637 Participants | 654 Participants | 662 Participants | 1953 Participants |
| Sex: Female, Male Male | 365 Participants | 344 Participants | 334 Participants | 1043 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 1,002 | 5 / 998 | 1 / 996 |
| other Total, other adverse events | 301 / 1,002 | 318 / 998 | 264 / 996 |
| serious Total, serious adverse events | 51 / 1,002 | 80 / 998 | 46 / 996 |
Outcome results
Primary
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16
PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Time frame: Baseline, Week 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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16 | -0.96 units on a scale | Standard Error 0.04 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16 | -0.97 units on a scale | Standard Error 0.04 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16 | -0.94 units on a scale | Standard Error 0.04 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.343195% CI: [-0.11, 0.04]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.633295% CI: [-0.09, 0.06]ANCOVA
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Week 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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | -3.22 units on a scale | Standard Error 0.11 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | -3.33 units on a scale | Standard Error 0.11 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | -3.07 units on a scale | Standard Error 0.11 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.014895% CI: [-0.46, -0.05]ANCOVA
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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.159795% CI: [-0.36, 0.06]ANCOVA
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time frame: Baseline, Week 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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | -3.27 units on a scale | Standard Error 0.11 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | -3.39 units on a scale | Standard Error 0.11 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | -3.08 units on a scale | Standard Error 0.11 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.00395% CI: [-0.52, -0.11]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.069195% CI: [-0.4, 0.02]ANCOVA
Primary
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tanezumab 2.5 mg | Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome | 38.3 events per 1000 participant-years |
| Tanezumab 5 mg | Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome | 71.5 events per 1000 participant-years |
| NSAID | Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome | 14.8 events per 1000 participant-years |
p-value: 0.001295% CI: [9.3, 37.7]Poisson model for rate difference
p-value: <0.000195% CI: [38.4, 74.9]Poisson model for rate difference
Primary
Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome
Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to \[\>=\] 2 millimeters \[mm\]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome | 3.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome | 7.1 percentage of participants |
| NSAID | Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome | 1.5 percentage of participants |
p-value: 0.012395% CI: [0.58, 4.68]Exact methods for risk difference
p-value: <0.000195% CI: [3.55, 8.14]Exact methods for risk difference
Secondary
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16
In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.
Time frame: Weeks 2, 4, 8 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 |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 8 | 1995.6 milligrams | Standard Error 322.53 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 2 | 2880.3 milligrams | Standard Error 353.05 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 16 | 1696.4 milligrams | Standard Error 307.8 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 4 | 2107.8 milligrams | Standard Error 302.24 |
| Tanezumab 5 mg | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 8 | 1628.8 milligrams | Standard Error 258.9 |
| Tanezumab 5 mg | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 4 | 1946.5 milligrams | Standard Error 277.29 |
| Tanezumab 5 mg | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 2 | 2898.7 milligrams | Standard Error 358.72 |
| Tanezumab 5 mg | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 16 | 1581.6 milligrams | Standard Error 284.12 |
| NSAID | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 16 | 2320.0 milligrams | Standard Error 413.14 |
| NSAID | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 2 | 3310.5 milligrams | Standard Error 410.42 |
| NSAID | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 4 | 2814.1 milligrams | Standard Error 401.29 |
| NSAID | Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 | Week 8 | 2839.7 milligrams | Standard Error 446 |
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.334895% CI: [0.66, 1.15]Negative binomial model
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.359595% CI: [0.66, 1.16]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.085495% CI: [0.54, 1.04]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.028195% CI: [0.5, 0.96]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.059595% CI: [0.49, 1.01]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.00395% CI: [0.4, 0.83]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.138995% CI: [0.48, 1.11]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.070995% CI: [0.45, 1.03]Negative binomial model
Secondary
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56
An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - \<1,500 counts) moderate (1,500 - \<6,500 counts), and vigorous (\>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A bout of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold.
Time frame: Baseline, Weeks 16 and 56
Population: Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 16 | 0.0 minutes |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Baseline | 0.0 minutes |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 56 | 0.0 minutes |
| Tanezumab 5 mg | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 16 | 0.0 minutes |
| Tanezumab 5 mg | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Baseline | 0.0 minutes |
| Tanezumab 5 mg | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 56 | -1.4 minutes |
| NSAID | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Baseline | 0.0 minutes |
| NSAID | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 56 | 0.0 minutes |
| NSAID | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 16 | 0.0 minutes |
Secondary
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56
An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {\<1500} counts moderate (1,500 - \<6500 counts), and vigorous (\>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Time frame: Baseline, Weeks 16 and 56
Population: Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 16 | 0.7 minutes |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Baseline | 41.2 minutes |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 56 | -3.8 minutes |
| Tanezumab 5 mg | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 16 | -1.6 minutes |
| Tanezumab 5 mg | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Baseline | 53.1 minutes |
| Tanezumab 5 mg | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 56 | 2.7 minutes |
| NSAID | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Baseline | 41.9 minutes |
| NSAID | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 56 | 7.4 minutes |
| NSAID | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 | Change at Week 16 | -0.1 minutes |
Secondary
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56
Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Time frame: Baseline, Weeks 16 and 56
Population: Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Change at Week 16 | 3.9 minutes |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Baseline | 97.0 minutes |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Change at Week 56 | -8.9 minutes |
| Tanezumab 5 mg | Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Change at Week 16 | 2.9 minutes |
| Tanezumab 5 mg | Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Baseline | 107.1 minutes |
| Tanezumab 5 mg | Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Change at Week 56 | -10.1 minutes |
| NSAID | Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Baseline | 99.2 minutes |
| NSAID | Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Change at Week 56 | 3.9 minutes |
| NSAID | Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 | Change at Week 16 | -4.2 minutes |
Secondary
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56
An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Time frame: Baseline, Weeks 16 and 56
Population: Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Change at Week 56 | -14552 physical activity counts |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Change at Week 16 | -470.0 physical activity counts |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Baseline | 75244 physical activity counts |
| Tanezumab 5 mg | Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Change at Week 16 | -2261 physical activity counts |
| Tanezumab 5 mg | Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Baseline | 95911 physical activity counts |
| Tanezumab 5 mg | Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Change at Week 56 | -8313 physical activity counts |
| NSAID | Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Baseline | 74414 physical activity counts |
| NSAID | Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Change at Week 56 | 4414.3 physical activity counts |
| NSAID | Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 | Change at Week 16 | 1202.9 physical activity counts |
Secondary
Change From Baseline in Average Daily Step Count at Weeks 16 and 56
Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Time frame: Baseline, Weeks 16 and 56
Population: Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Change at Week 16 | 350.9 step count |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Baseline | 4851.0 step count |
| Tanezumab 2.5 mg | Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Change at Week 56 | -1938 step count |
| Tanezumab 5 mg | Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Change at Week 16 | 87.8 step count |
| Tanezumab 5 mg | Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Baseline | 5834.8 step count |
| Tanezumab 5 mg | Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Change at Week 56 | -543.2 step count |
| NSAID | Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Baseline | 4779.0 step count |
| NSAID | Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Change at Week 56 | 242.6 step count |
| NSAID | Change From Baseline in Average Daily Step Count at Weeks 16 and 56 | Change at Week 16 | -705.7 step count |
Secondary
Change From Baseline in Average Pain Score in the Index Joint at Week 64
Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
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 who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Week 64 | Baseline | 6.76 units on a scale | Standard Deviation 1.59 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Week 64 | Change at Week 64 | -3.01 units on a scale | Standard Deviation 2.6 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Week 64 | Baseline | 6.77 units on a scale | Standard Deviation 1.58 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Week 64 | Change at Week 64 | -2.81 units on a scale | Standard Deviation 2.71 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Week 64 | Baseline | 6.76 units on a scale | Standard Deviation 1.54 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Week 64 | Change at Week 64 | -3.24 units on a scale | Standard Deviation 2.55 |
Secondary
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56
Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 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).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 8 | -1.83 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 3 | -1.40 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.35 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 10 | -2.35 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.02 units on a scale | Standard Error 0.07 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 20 | -2.56 units on a scale | Standard Error 0.11 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 12 | -2.48 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.25 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.41 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 4 | -1.62 units on a scale | Standard Error 0.09 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.17 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 1 | -0.47 units on a scale | Standard Error 0.05 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 6 | -1.85 units on a scale | Standard Error 0.09 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.20 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.27 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.26 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 1 | -0.56 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 2 | -0.97 units on a scale | Standard Error 0.07 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 3 | -1.30 units on a scale | Standard Error 0.08 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 4 | -1.65 units on a scale | Standard Error 0.09 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 6 | -1.97 units on a scale | Standard Error 0.09 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.04 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 10 | -2.46 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 12 | -2.55 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.52 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 20 | -2.60 units on a scale | Standard Error 0.11 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.41 units on a scale | Standard Error 0.12 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.20 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.10 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.03 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 8 | -1.59 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.03 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.11 units on a scale | Standard Error 0.12 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 6 | -1.49 units on a scale | Standard Error 0.09 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 4 | -1.32 units on a scale | Standard Error 0.09 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.06 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 3 | -1.23 units on a scale | Standard Error 0.08 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 1 | -0.56 units on a scale | Standard Error 0.05 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.07 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 12 | -2.10 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 2 | -0.91 units on a scale | Standard Error 0.07 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.17 units on a scale | Standard Error 0.11 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 10 | -1.98 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.04 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 | Change at Week 20 | -2.27 units on a scale | Standard Error 0.11 |
Comparison: Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.11295% CI: [-0.02, 0.2]ANCOVA
Comparison: Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.968695% CI: [-0.11, 0.11]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.158995% CI: [-0.25, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.47295% CI: [-0.2, 0.09]ANCOVA
Comparison: Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.03295% CI: [-0.33, -0.01]ANCOVA
Comparison: Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.333695% CI: [-0.24, 0.08]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000595% CI: [-0.47, -0.13]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000195% CI: [-0.5, -0.16]ANCOVA
Comparison: Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-0.55, -0.18]ANCOVA
Comparison: Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-0.66, -0.3]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.011595% CI: [-0.42, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-0.63, -0.26]ANCOVA
Comparison: Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000295% CI: [-0.56, -0.17]ANCOVA
Comparison: Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-0.67, -0.28]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000295% CI: [-0.57, -0.18]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-0.64, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.023895% CI: [-0.44, -0.03]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.001195% CI: [-0.55, -0.14]ANCOVA
Comparison: Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.006495% CI: [-0.51, -0.08]ANCOVA
Comparison: Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.002595% CI: [-0.54, -0.12]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.058995% CI: [-0.48, 0.01]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.01895% CI: [-0.53, -0.05]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.094495% CI: [-0.47, 0.04]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.119895% CI: [-0.45, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.183795% CI: [-0.43, 0.08]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.31795% CI: [-0.39, 0.13]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.187395% CI: [-0.43, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.571995% CI: [-0.33, 0.18]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.357195% CI: [-0.39, 0.14]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.907295% CI: [-0.25, 0.28]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).
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. Here, Number analyzed signifies those participants who were evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 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 | -2.8 millimeters of mercury (mmHg) | Standard Deviation 11.95 |
| Tanezumab 2.5 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 | -2.7 millimeters of mercury (mmHg) | Standard Deviation 11.69 |
| Tanezumab 2.5 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 | -4.0 millimeters of mercury (mmHg) | Standard Deviation 11.44 |
| Tanezumab 2.5 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 | -2.9 millimeters of mercury (mmHg) | Standard Deviation 12.16 |
| Tanezumab 2.5 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 | -3.0 millimeters of mercury (mmHg) | Standard Deviation 11.66 |
| Tanezumab 2.5 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 | -3.0 millimeters of mercury (mmHg) | Standard Deviation 12.35 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | SBP: Baseline | 128.9 millimeters of mercury (mmHg) | Standard Deviation 12.91 |
| Tanezumab 2.5 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 | -2.5 millimeters of mercury (mmHg) | Standard Deviation 11.35 |
| Tanezumab 2.5 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 | -2.7 millimeters of mercury (mmHg) | Standard Deviation 12.21 |
| Tanezumab 2.5 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 | -3.1 millimeters of mercury (mmHg) | Standard Deviation 11.76 |
| Tanezumab 2.5 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 | -2.1 millimeters of mercury (mmHg) | Standard Deviation 13.4 |
| Tanezumab 2.5 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 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 13.24 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | DBP: Baseline | 79.3 millimeters of mercury (mmHg) | Standard Deviation 8.56 |
| Tanezumab 2.5 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 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 8.29 |
| Tanezumab 2.5 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 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 8.06 |
| Tanezumab 2.5 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 | -1.1 millimeters of mercury (mmHg) | Standard Deviation 7.84 |
| Tanezumab 2.5 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 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 8.14 |
| Tanezumab 2.5 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 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 8.39 |
| Tanezumab 2.5 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 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 8.28 |
| Tanezumab 2.5 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 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 8.07 |
| Tanezumab 2.5 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 | -0.9 millimeters of mercury (mmHg) | Standard Deviation 8.82 |
| Tanezumab 2.5 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 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 8.61 |
| Tanezumab 2.5 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 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 8.63 |
| Tanezumab 2.5 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 | -0.6 millimeters of mercury (mmHg) | Standard Deviation 8.73 |
| 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 | -1.9 millimeters of mercury (mmHg) | Standard Deviation 9.11 |
| 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 | 129.3 millimeters of mercury (mmHg) | Standard Deviation 13.43 |
| 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 | 79.1 millimeters of mercury (mmHg) | Standard Deviation 8.68 |
| 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 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 8.53 |
| 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 | -4.2 millimeters of mercury (mmHg) | Standard Deviation 11.92 |
| 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 | -2.1 millimeters of mercury (mmHg) | Standard Deviation 13.56 |
| 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 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 8.89 |
| 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 | -4.9 millimeters of mercury (mmHg) | Standard Deviation 12.68 |
| 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 | -2.1 millimeters of mercury (mmHg) | Standard Deviation 7.96 |
| 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 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 9.23 |
| 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 | -3.8 millimeters of mercury (mmHg) | Standard Deviation 12.6 |
| 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 | -3.4 millimeters of mercury (mmHg) | Standard Deviation 13.78 |
| 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 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 8.91 |
| 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 | -3.7 millimeters of mercury (mmHg) | Standard Deviation 12.95 |
| 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 | -2.5 millimeters of mercury (mmHg) | Standard Deviation 8.1 |
| 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 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 13.71 |
| 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 | -3.1 millimeters of mercury (mmHg) | Standard Deviation 13.49 |
| 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 | -3.0 millimeters of mercury (mmHg) | Standard Deviation 13.29 |
| 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 | -0.6 millimeters of mercury (mmHg) | Standard Deviation 9.66 |
| 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 | -3.3 millimeters of mercury (mmHg) | Standard Deviation 13.7 |
| 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 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 8.24 |
| 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 | -1.4 millimeters of mercury (mmHg) | Standard Deviation 9.14 |
| 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 | -3.8 millimeters of mercury (mmHg) | Standard Deviation 14.41 |
| 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 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 8.9 |
| NSAID | 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 | -2.3 millimeters of mercury (mmHg) | Standard Deviation 13.42 |
| NSAID | 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 12.97 |
| NSAID | 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 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 12.64 |
| NSAID | 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 | -2.8 millimeters of mercury (mmHg) | Standard Deviation 13.33 |
| NSAID | 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 8.69 |
| NSAID | 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 | -2.3 millimeters of mercury (mmHg) | Standard Deviation 13.31 |
| NSAID | 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 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 9.03 |
| NSAID | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | DBP: Baseline | 79.3 millimeters of mercury (mmHg) | Standard Deviation 8.57 |
| NSAID | 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 7.84 |
| NSAID | 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 | -1.5 millimeters of mercury (mmHg) | Standard Deviation 8.65 |
| NSAID | 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 | -1.4 millimeters of mercury (mmHg) | Standard Deviation 8.19 |
| NSAID | 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 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 9.35 |
| NSAID | 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 | -1.1 millimeters of mercury (mmHg) | Standard Deviation 8.23 |
| NSAID | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | SBP: Baseline | 128.8 millimeters of mercury (mmHg) | Standard Deviation 13.26 |
| NSAID | 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 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 11.24 |
| NSAID | 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 | -1.1 millimeters of mercury (mmHg) | Standard Deviation 8.3 |
| NSAID | 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 11.29 |
| NSAID | 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 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 8.69 |
| NSAID | 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 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 11.68 |
| NSAID | 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 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 12.37 |
| NSAID | 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 | -1.4 millimeters of mercury (mmHg) | Standard Deviation 8.26 |
| NSAID | 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 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 11.83 |
| NSAID | 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 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 13.49 |
| NSAID | 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 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 8.91 |
Secondary
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 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 (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (\>) 30 millisecond (ms) or 60 ms; absolute value \> 450 ms, \>480 ms and \> 500 ms; 2) heart rate (HR) : absolute value \<=50 bpm and decrease from baseline \>=20 bpm; absolute value \>=120 beats per minute (bpm) and increase from baseline \>=20 bpm; 3) PR interval: absolute value \>=220 ms and increase from baseline \>=20 ms; 4) QRS interval: absolute value \>= 120 ms.
Time frame: Baseline, Weeks 56 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | PR Interval:Change at Week 56 | 1.7 milliseconds | Standard Deviation 12.98 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | RR Interval:Change at Week 56 | -26.3 milliseconds | Standard Deviation 123.23 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | RR Interval:Change at Week 80 | -33.6 milliseconds | Standard Deviation 119.23 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | PR Interval: Baseline | 165.0 milliseconds | Standard Deviation 27.43 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | RR Interval: Baseline | 940.5 milliseconds | Standard Deviation 136.21 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | PR Interval:Change at Week 80 | 0.3 milliseconds | Standard Deviation 13.39 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QRS Interval: Baseline | 94.9 milliseconds | Standard Deviation 13.12 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QRS Interval:Change at Week 56 | 0.2 milliseconds | Standard Deviation 8.22 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QRS Interval:Change at Week 80 | -0.2 milliseconds | Standard Deviation 8.12 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QT Interval: Baseline | 405.0 milliseconds | Standard Deviation 28.86 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QT Interval:Change at Week 56 | -3.5 milliseconds | Standard Deviation 24.07 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QT Interval:Change at Week 80 | -6.2 milliseconds | Standard Deviation 22.56 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCB Interval: Baseline | 419.3 milliseconds | Standard Deviation 21.85 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCB Interval:Change at Week 56 | 2.3 milliseconds | Standard Deviation 18.82 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCB Interval:Change at Week 80 | 1.5 milliseconds | Standard Deviation 19.37 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCF Interval: Baseline | 414.2 milliseconds | Standard Deviation 19.96 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCF Interval:Change at Week 56 | 0.3 milliseconds | Standard Deviation 16.24 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCF Interval:Change at Week 80 | -1.2 milliseconds | Standard Deviation 16.16 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCF Interval:Change at Week 80 | -2.1 milliseconds | Standard Deviation 15.55 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | RR Interval: Baseline | 940.1 milliseconds | Standard Deviation 144.48 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QT Interval: Baseline | 403.8 milliseconds | Standard Deviation 30.08 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCB Interval: Baseline | 418.5 milliseconds | Standard Deviation 21.96 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | RR Interval:Change at Week 56 | -22.6 milliseconds | Standard Deviation 128.58 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCB Interval:Change at Week 80 | 0.2 milliseconds | Standard Deviation 17.98 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCF Interval: Baseline | 413.3 milliseconds | Standard Deviation 20.09 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | RR Interval:Change at Week 80 | -32.4 milliseconds | Standard Deviation 126.08 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QT Interval:Change at Week 56 | -4.5 milliseconds | Standard Deviation 25.06 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCF Interval:Change at Week 56 | -1.2 milliseconds | Standard Deviation 15.55 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | PR Interval: Baseline | 165.9 milliseconds | Standard Deviation 25.45 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QRS Interval:Change at Week 80 | 1.0 milliseconds | Standard Deviation 8.64 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCB Interval:Change at Week 56 | 0.5 milliseconds | Standard Deviation 17.83 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | PR Interval:Change at Week 56 | 0.6 milliseconds | Standard Deviation 13.33 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QRS Interval:Change at Week 56 | 0.4 milliseconds | Standard Deviation 8.3 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QT Interval:Change at Week 80 | -6.8 milliseconds | Standard Deviation 24.46 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | PR Interval:Change at Week 80 | -0.8 milliseconds | Standard Deviation 14.7 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QRS Interval: Baseline | 94.6 milliseconds | Standard Deviation 13.65 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | PR Interval:Change at Week 80 | 0.6 milliseconds | Standard Deviation 13.8 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QRS Interval: Baseline | 94.3 milliseconds | Standard Deviation 13.16 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QRS Interval:Change at Week 56 | -0.4 milliseconds | Standard Deviation 7.39 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCB Interval:Change at Week 80 | 1.7 milliseconds | Standard Deviation 19.06 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QRS Interval:Change at Week 80 | -0.1 milliseconds | Standard Deviation 7.81 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCF Interval:Change at Week 80 | -1.0 milliseconds | Standard Deviation 16.21 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QT Interval: Baseline | 404.3 milliseconds | Standard Deviation 29.33 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QT Interval:Change at Week 56 | -2.9 milliseconds | Standard Deviation 26.58 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCF Interval: Baseline | 414.3 milliseconds | Standard Deviation 19.49 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QT Interval:Change at Week 80 | -6.0 milliseconds | Standard Deviation 25.34 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | RR Interval: Baseline | 936.1 milliseconds | Standard Deviation 142.31 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | RR Interval:Change at Week 56 | -14.9 milliseconds | Standard Deviation 128.73 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCB Interval: Baseline | 419.7 milliseconds | Standard Deviation 21.6 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | RR Interval:Change at Week 80 | -34.3 milliseconds | Standard Deviation 133.83 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | PR Interval: Baseline | 163.9 milliseconds | Standard Deviation 23.98 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | PR Interval:Change at Week 56 | 1.7 milliseconds | Standard Deviation 14.4 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCB Interval:Change at Week 56 | 0.2 milliseconds | Standard Deviation 19.66 |
| NSAID | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 | QTCF Interval:Change at Week 56 | -0.8 milliseconds | Standard Deviation 17.5 |
Secondary
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80
Heart rate was measured at sitting position.
Time frame: Baseline, Weeks 56 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Change at Week 56 | 2.0 beats per minute | Standard Deviation 9.1 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Baseline | 65.2 beats per minute | Standard Deviation 9.7 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Change at Week 80 | 2.7 beats per minute | Standard Deviation 9 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Change at Week 56 | 1.7 beats per minute | Standard Deviation 9.72 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Baseline | 65.4 beats per minute | Standard Deviation 10.3 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Change at Week 80 | 2.3 beats per minute | Standard Deviation 9.34 |
| NSAID | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Baseline | 65.6 beats per minute | Standard Deviation 10.36 |
| NSAID | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Change at Week 80 | 2.5 beats per minute | Standard Deviation 10.02 |
| NSAID | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Change at Week 56 | 1.0 beats per minute | Standard Deviation 9.95 |
Secondary
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Heart rate (pulse rate) was measured at sitting position.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 70.8 beats per minute | Standard Deviation 9.09 |
| Tanezumab 2.5 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 | 1.8 beats per minute | Standard Deviation 8.65 |
| Tanezumab 2.5 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 | 1.6 beats per minute | Standard Deviation 9 |
| Tanezumab 2.5 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 | 0.7 beats per minute | Standard Deviation 9.06 |
| Tanezumab 2.5 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 | 0.5 beats per minute | Standard Deviation 9.37 |
| Tanezumab 2.5 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 | 0.4 beats per minute | Standard Deviation 9.46 |
| Tanezumab 2.5 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 | 1.2 beats per minute | Standard Deviation 9.67 |
| Tanezumab 2.5 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 9.89 |
| Tanezumab 2.5 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 | 0.6 beats per minute | Standard Deviation 9.86 |
| Tanezumab 2.5 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 | 0.2 beats per minute | Standard Deviation 9.51 |
| Tanezumab 2.5 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 | 1.5 beats per minute | Standard Deviation 9.81 |
| Tanezumab 2.5 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 | 0.9 beats per minute | Standard Deviation 10.24 |
| 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 | 0.6 beats per minute | Standard Deviation 9.97 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 70.5 beats per minute | Standard Deviation 9.66 |
| 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 | 1.6 beats per minute | Standard Deviation 9.34 |
| 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 | 1.0 beats per minute | Standard Deviation 9.34 |
| 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 | 2.0 beats per minute | Standard Deviation 8.5 |
| 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 | 0.7 beats per minute | Standard Deviation 9.36 |
| 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 | 1.5 beats per minute | Standard Deviation 9.55 |
| 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 | 2.0 beats per minute | Standard Deviation 9.03 |
| 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 | 1.6 beats per minute | Standard Deviation 9.4 |
| 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 | 0.5 beats per minute | Standard Deviation 9.14 |
| 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 | 0.8 beats per minute | Standard Deviation 8.54 |
| 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 | 0.1 beats per minute | Standard Deviation 10.15 |
| NSAID | 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 8.78 |
| NSAID | 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 8.86 |
| NSAID | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 56 | -0.0 beats per minute | Standard Deviation 9.28 |
| NSAID | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 24 | 0.8 beats per minute | Standard Deviation 9.24 |
| NSAID | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 32 | 1.7 beats per minute | Standard Deviation 9.7 |
| NSAID | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 40 | 1.4 beats per minute | Standard Deviation 8.71 |
| NSAID | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 64 | 0.5 beats per minute | Standard Deviation 9.84 |
| NSAID | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 70.6 beats per minute | Standard Deviation 9.36 |
| NSAID | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 2 | 1.1 beats per minute | Standard Deviation 8.31 |
| NSAID | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 48 | 1.3 beats per minute | Standard Deviation 9.44 |
| NSAID | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Change at Week 4 | 1.2 beats per minute | Standard Deviation 8.75 |
| NSAID | 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 9.61 |
Secondary
Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
Time frame: Baseline, Weeks 56 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure, and Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change at Week 56 | -0.35 millimeter | Standard Error 0.06 |
| Tanezumab 2.5 mg | Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change at Week 80 | -0.46 millimeter | Standard Error 0.07 |
| Tanezumab 5 mg | Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change at Week 56 | -0.40 millimeter | Standard Error 0.06 |
| Tanezumab 5 mg | Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change at Week 80 | -0.35 millimeter | Standard Error 0.07 |
| NSAID | Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change at Week 56 | -0.21 millimeter | Standard Error 0.06 |
| NSAID | Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change at Week 80 | -0.28 millimeter | Standard Error 0.07 |
Comparison: Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.10295% CI: [-0.3, 0.03]ANCOVA
Comparison: Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.02395% CI: [-0.35, -0.03]ANCOVA
Comparison: Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.064595% CI: [-0.37, 0.01]ANCOVA
Comparison: Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.500595% CI: [-0.26, 0.13]ANCOVA
Secondary
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 \[no radiographic features of OA\], 1 \[doubtful joint space narrowing (JSN) and possible osteophytic lipping\], 2 \[definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph\], 3 \[multiple osteophytes, definite JSN, sclerosis, possible bony deformity\], 4 \[large osteophytes, marked JSN, severe sclerosis and definite bony deformity\]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral).
Time frame: Baseline, Weeks 56 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure, and Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Medial JSW at Week 56 | -0.25 millimeter | Standard Error 0.03 |
| Tanezumab 2.5 mg | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Medial JSW at Week 80 | -0.33 millimeter | Standard Error 0.04 |
| Tanezumab 2.5 mg | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Lateral JSW at Week 56 | -0.26 millimeter | Standard Error 0.07 |
| Tanezumab 2.5 mg | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Lateral JSW at Week 80 | -0.46 millimeter | Standard Error 0.08 |
| Tanezumab 5 mg | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Lateral JSW at Week 80 | -0.32 millimeter | Standard Error 0.09 |
| Tanezumab 5 mg | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Medial JSW at Week 56 | -0.34 millimeter | Standard Error 0.03 |
| Tanezumab 5 mg | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Lateral JSW at Week 56 | -0.32 millimeter | Standard Error 0.07 |
| Tanezumab 5 mg | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Medial JSW at Week 80 | -0.37 millimeter | Standard Error 0.04 |
| NSAID | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Lateral JSW at Week 80 | -0.37 millimeter | Standard Error 0.08 |
| NSAID | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Medial JSW at Week 80 | -0.25 millimeter | Standard Error 0.03 |
| NSAID | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Lateral JSW at Week 56 | -0.27 millimeter | Standard Error 0.07 |
| NSAID | Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 | Change in Medial JSW at Week 56 | -0.19 millimeter | Standard Error 0.03 |
Comparison: Change in medial JSW width at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.097995% CI: [-0.15, 0.01]ANCOVA
Comparison: Change in medial JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: <0.000195% CI: [-0.24, -0.08]ANCOVA
Comparison: Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.116295% CI: [-0.17, 0.02]ANCOVA
Comparison: Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.012895% CI: [-0.22, -0.03]ANCOVA
Comparison: Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.888595% CI: [-0.17, 0.2]ANCOVA
Comparison: Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.634595% CI: [-0.24, 0.15]ANCOVA
Comparison: Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.440695% CI: [-0.32, 0.14]ANCOVA
Comparison: Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.p-value: 0.710995% CI: [-0.19, 0.28]ANCOVA
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 1.85 units on a scale | Standard Deviation 4.3 |
| Tanezumab 2.5 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 | -0.22 units on a scale | Standard Deviation 2.15 |
| Tanezumab 2.5 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 | -0.16 units on a scale | Standard Deviation 2.06 |
| Tanezumab 2.5 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 | -0.27 units on a scale | Standard Deviation 2.28 |
| Tanezumab 2.5 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 | -0.27 units on a scale | Standard Deviation 2.32 |
| Tanezumab 2.5 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 | -0.32 units on a scale | Standard Deviation 2.39 |
| Tanezumab 2.5 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 | -0.37 units on a scale | Standard Deviation 2.46 |
| Tanezumab 2.5 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 | -0.35 units on a scale | Standard Deviation 2.42 |
| Tanezumab 2.5 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 | -0.37 units on a scale | Standard Deviation 2.46 |
| Tanezumab 2.5 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 | -0.35 units on a scale | Standard Deviation 2.48 |
| Tanezumab 2.5 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 | -0.32 units on a scale | Standard Deviation 2.6 |
| Tanezumab 2.5 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 | -0.35 units on a scale | Standard Deviation 2.53 |
| 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 | -0.47 units on a scale | Standard Deviation 3.35 |
| 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 | 1.70 units on a scale | Standard Deviation 4.45 |
| 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 | -0.40 units on a scale | Standard Deviation 2.75 |
| 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 | -0.49 units on a scale | Standard Deviation 3.13 |
| 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 | -0.13 units on a scale | Standard Deviation 1.4 |
| 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 | -0.35 units on a scale | Standard Deviation 2.76 |
| 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 | -0.47 units on a scale | Standard Deviation 3.24 |
| 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 | -0.17 units on a scale | Standard Deviation 1.92 |
| 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 | -0.43 units on a scale | Standard Deviation 2.8 |
| 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 | -0.31 units on a scale | Standard Deviation 2.48 |
| 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 | -0.22 units on a scale | Standard Deviation 2.08 |
| 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 | -0.52 units on a scale | Standard Deviation 3.26 |
| NSAID | 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 | -0.36 units on a scale | Standard Deviation 2.55 |
| NSAID | 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 | -0.47 units on a scale | Standard Deviation 3.06 |
| NSAID | 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 | -0.58 units on a scale | Standard Deviation 3.22 |
| NSAID | 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 | -0.49 units on a scale | Standard Deviation 3.08 |
| NSAID | 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 | -0.53 units on a scale | Standard Deviation 3.17 |
| NSAID | 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 | -0.53 units on a scale | Standard Deviation 3.32 |
| NSAID | 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 | -0.57 units on a scale | Standard Deviation 3.2 |
| NSAID | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 | Baseline | 1.87 units on a scale | Standard Deviation 4.47 |
| NSAID | 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 1.67 |
| NSAID | 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 | -0.55 units on a scale | Standard Deviation 3.21 |
| NSAID | 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 | -0.19 units on a scale | Standard Deviation 2.32 |
| NSAID | 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 | -0.62 units on a scale | Standard Deviation 3.28 |
Secondary
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64
PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom 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 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 who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 | Baseline | 3.49 units on a scale | Standard Deviation 0.61 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 | Change at Week 64 | -0.79 units on a scale | Standard Deviation 0.96 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 | Baseline | 3.46 units on a scale | Standard Deviation 0.6 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 | Change at Week 64 | -0.64 units on a scale | Standard Deviation 0.98 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 | Baseline | 3.44 units on a scale | Standard Deviation 0.59 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 | Change at Week 64 | -0.95 units on a scale | Standard Deviation 0.96 |
Secondary
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Time frame: Baseline, Weeks 2, 4, 8, 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).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 2 | -0.67 units on a scale | Standard Error 0.03 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 4 | -0.81 units on a scale | Standard Error 0.03 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 8 | -0.77 units on a scale | Standard Error 0.03 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 24 | -0.74 units on a scale | Standard Error 0.05 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 32 | -0.72 units on a scale | Standard Error 0.05 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 40 | -0.70 units on a scale | Standard Error 0.05 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 48 | -0.70 units on a scale | Standard Error 0.05 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 56 | -0.65 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 8 | -0.85 units on a scale | Standard Error 0.03 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 48 | -0.66 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 24 | -0.79 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 32 | -0.71 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 40 | -0.69 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 2 | -0.67 units on a scale | Standard Error 0.03 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 4 | -0.84 units on a scale | Standard Error 0.03 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 56 | -0.60 units on a scale | Standard Error 0.05 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 8 | -0.76 units on a scale | Standard Error 0.03 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 4 | -0.69 units on a scale | Standard Error 0.03 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 2 | -0.63 units on a scale | Standard Error 0.03 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 24 | -0.74 units on a scale | Standard Error 0.05 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 48 | -0.67 units on a scale | Standard Error 0.05 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 40 | -0.69 units on a scale | Standard Error 0.05 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 32 | -0.72 units on a scale | Standard Error 0.05 |
| NSAID | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 56 | -0.66 units on a scale | Standard Error 0.05 |
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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.215995% CI: [-0.1, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.204995% CI: [-0.1, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000295% CI: [-0.19, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.21, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.779995% CI: [-0.08, 0.06]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.006195% CI: [-0.16, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.971895% CI: [-0.1, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.329295% CI: [-0.14, 0.05]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.98395% CI: [-0.1, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.913795% CI: [-0.09, 0.11]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.878495% CI: [-0.11, 0.09]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.999595% CI: [-0.1, 0.1]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.664895% CI: [-0.13, 0.08]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.72895% CI: [-0.09, 0.12]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.885695% CI: [-0.09, 0.11]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.281495% CI: [-0.05, 0.16]ANCOVA
Secondary
Change From Baseline 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.
Time frame: Baseline, Weeks 24, 56 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Baseline | 0.47 units on a scale | Standard Deviation 0.76 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 24 | 0.21 units on a scale | Standard Deviation 1.13 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 56 | 0.28 units on a scale | Standard Deviation 1.19 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 80 | 0.89 units on a scale | Standard Deviation 1.39 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Baseline | 1.10 units on a scale | Standard Deviation 1.84 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Change at Week 24 | 0.66 units on a scale | Standard Deviation 2.9 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Change at Week 56 | 0.97 units on a scale | Standard Deviation 3.29 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Change at Week 80 | 1.33 units on a scale | Standard Deviation 3.85 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 56 | 0.33 units on a scale | Standard Deviation 1.34 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Change at Week 56 | 1.21 units on a scale | Standard Deviation 4.01 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 80 | 0.94 units on a scale | Standard Deviation 1.43 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Baseline | 1.23 units on a scale | Standard Deviation 1.89 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Change at Week 24 | 0.52 units on a scale | Standard Deviation 3.19 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Baseline | 0.53 units on a scale | Standard Deviation 0.78 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 24 | 0.18 units on a scale | Standard Deviation 1.22 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Change at Week 80 | 1.31 units on a scale | Standard Deviation 4.36 |
| NSAID | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 56 | 0.22 units on a scale | Standard Deviation 1.21 |
| NSAID | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 24 | 0.11 units on a scale | Standard Deviation 1.2 |
| NSAID | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Baseline | 0.49 units on a scale | Standard Deviation 0.76 |
| NSAID | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Number of symptoms reported: Change at Week 80 | 0.74 units on a scale | Standard Deviation 1.22 |
| NSAID | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Change at Week 56 | 0.82 units on a scale | Standard Deviation 3.4 |
| NSAID | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Change at Week 24 | 0.33 units on a scale | Standard Deviation 2.99 |
| NSAID | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Baseline | 1.13 units on a scale | Standard Deviation 1.82 |
| NSAID | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 | Total symptom impact score: Change at Week 80 | 0.89 units on a scale | Standard Deviation 3.65 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
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 who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 | Baseline | 7.09 units on a scale | Standard Deviation 1.08 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 | Change at Week 64 | -3.40 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 | Baseline | 7.10 units on a scale | Standard Deviation 1.1 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 | Change at Week 64 | -3.09 units on a scale | Standard Deviation 2.37 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 | Baseline | 7.01 units on a scale | Standard Deviation 1.08 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 | Change at Week 64 | -3.77 units on a scale | Standard Deviation 2.06 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.26 units on a scale | Standard Error 0.11 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.45 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.65 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.74 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.73 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.56 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.44 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.28 units on a scale | Standard Error 0.09 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.57 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.88 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.61 units on a scale | Standard Error 0.08 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.34 units on a scale | Standard Error 0.09 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.71 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.41 units on a scale | Standard Error 0.11 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.69 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.58 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.48 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.38 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.23 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.52 units on a scale | Standard Error 0.08 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.49 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -1.95 units on a scale | Standard Error 0.09 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.40 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.64 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.07 units on a scale | Standard Error 0.11 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.44 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.54 units on a scale | Standard Error 0.13 |
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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.011995% CI: [-0.37, -0.05]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.307395% CI: [-0.24, 0.08]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000295% CI: [-0.5, -0.15]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.56, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.025195% CI: [-0.39, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.66, -0.3]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.062595% CI: [-0.39, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.00195% CI: [-0.54, -0.14]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.400595% CI: [-0.36, 0.14]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.05395% CI: [-0.5, 0]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.407495% CI: [-0.37, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.262995% CI: [-0.41, 0.11]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.558295% CI: [-0.34, 0.18]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.490795% CI: [-0.35, 0.17]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.404395% CI: [-0.38, 0.15]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.766395% CI: [-0.31, 0.23]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.741595% CI: [-0.31, 0.22]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.868895% CI: [-0.24, 0.29]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme 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). Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64 | Baseline | 7.89 units on a scale | Standard Deviation 1.24 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64 | Change at Week 64 | -3.28 units on a scale | Standard Deviation 2.67 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64 | Baseline | 7.88 units on a scale | Standard Deviation 1.29 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64 | Change at Week 64 | -2.97 units on a scale | Standard Deviation 2.69 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64 | Baseline | 7.83 units on a scale | Standard Deviation 1.19 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64 | Change at Week 64 | -3.70 units on a scale | Standard Deviation 2.5 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.34 units on a scale | Standard Error 0.11 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.55 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.76 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.89 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.81 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.70 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.48 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.34 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.69 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -3.03 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.66 units on a scale | Standard Error 0.08 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.43 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.81 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.50 units on a scale | Standard Error 0.11 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.84 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.74 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.63 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.47 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.40 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.66 units on a scale | Standard Error 0.09 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.70 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.08 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.55 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.83 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.18 units on a scale | Standard Error 0.12 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.67 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.74 units on a scale | Standard Error 0.14 |
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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.084695% CI: [-0.33, 0.02]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.974995% CI: [-0.18, 0.17]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.007695% CI: [-0.45, -0.07]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000395% CI: [-0.54, -0.16]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.440295% CI: [-0.27, 0.12]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.61, -0.21]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.154395% CI: [-0.38, 0.06]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.005395% CI: [-0.53, -0.09]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.644595% CI: [-0.33, 0.2]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.143995% CI: [-0.47, 0.07]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.840295% CI: [-0.3, 0.25]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.443995% CI: [-0.38, 0.17]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.937695% CI: [-0.27, 0.29]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.761495% CI: [-0.33, 0.24]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.808195% CI: [-0.32, 0.25]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.807895% CI: [-0.25, 0.33]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.970595% CI: [-0.28, 0.29]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.578595% CI: [-0.21, 0.38]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme 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). Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64 | Baseline | 6.86 units on a scale | Standard Deviation 1.33 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64 | Change at Week 64 | -3.20 units on a scale | Standard Deviation 2.78 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64 | Baseline | 6.90 units on a scale | Standard Deviation 1.34 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64 | Change at Week 64 | -2.69 units on a scale | Standard Deviation 2.58 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64 | Baseline | 6.86 units on a scale | Standard Deviation 1.3 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64 | Change at Week 64 | -3.67 units on a scale | Standard Deviation 2.32 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.01 units on a scale | Standard Error 0.11 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.37 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.54 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.64 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.54 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.45 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.26 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.14 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.48 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.76 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.39 units on a scale | Standard Error 0.08 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.15 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.47 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.13 units on a scale | Standard Error 0.11 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.54 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.42 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.34 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.21 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.22 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.46 units on a scale | Standard Error 0.08 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.48 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -1.91 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.39 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.60 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.95 units on a scale | Standard Error 0.11 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.42 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.52 units on a scale | Standard Error 0.14 |
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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.362295% CI: [-0.25, 0.09]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.389495% CI: [-0.09, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.013795% CI: [-0.42, -0.05]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.010695% CI: [-0.43, -0.06]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.717995% CI: [-0.23, 0.16]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.01295% CI: [-0.44, -0.05]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.537295% CI: [-0.28, 0.15]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.089995% CI: [-0.4, 0.03]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.764695% CI: [-0.3, 0.22]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.254795% CI: [-0.41, 0.11]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.880695% CI: [-0.29, 0.25]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.841695% CI: [-0.3, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.998195% CI: [-0.28, 0.28]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.648595% CI: [-0.21, 0.34]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.831795% CI: [-0.3, 0.24]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.581995% CI: [-0.19, 0.35]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.853895% CI: [-0.26, 0.31]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.198195% CI: [-0.1, 0.47]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
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 who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 | Baseline | 7.15 units on a scale | Standard Deviation 1.42 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 | Change at Week 64 | -3.31 units on a scale | Standard Deviation 2.72 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 | Baseline | 7.20 units on a scale | Standard Deviation 1.4 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 | Change at Week 64 | -3.04 units on a scale | Standard Deviation 2.64 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 | Baseline | 7.09 units on a scale | Standard Deviation 1.42 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 | Change at Week 64 | -3.66 units on a scale | Standard Deviation 2.36 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.32 units on a scale | Standard Error 0.11 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.46 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.68 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.77 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.79 units on a scale | Standard Error 0.09 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.60 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.46 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.32 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.58 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.95 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.70 units on a scale | Standard Error 0.09 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.43 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.79 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.54 units on a scale | Standard Error 0.11 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.74 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.64 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.54 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.46 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.16 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.48 units on a scale | Standard Error 0.09 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.46 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -1.95 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.42 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.63 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.10 units on a scale | Standard Error 0.11 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.44 units on a scale | Standard Error 0.14 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.52 units on a scale | Standard Error 0.13 |
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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000495% CI: [-0.49, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.013495% CI: [-0.4, -0.05]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.56, -0.19]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.67, -0.29]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.003195% CI: [-0.49, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.82, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.042595% CI: [-0.43, -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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.65, -0.23]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.29895% CI: [-0.4, 0.12]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.017995% CI: [-0.58, -0.05]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.232895% CI: [-0.42, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.101995% CI: [-0.49, 0.04]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.400295% CI: [-0.38, 0.15]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.214995% CI: [-0.45, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.244295% CI: [-0.43, 0.11]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.460995% CI: [-0.37, 0.17]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.812995% CI: [-0.31, 0.24]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.788395% CI: [-0.32, 0.24]ANCOVA
Secondary
Change From Baseline in WOMAC Pain Subscale at Week 64
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
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 who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Week 64 | Baseline | 7.01 units on a scale | Standard Deviation 1.12 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Week 64 | Change at Week 64 | -3.47 units on a scale | Standard Deviation 2.45 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Week 64 | Baseline | 7.02 units on a scale | Standard Deviation 1.12 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Week 64 | Change at Week 64 | -3.12 units on a scale | Standard Deviation 2.4 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Week 64 | Change at Week 64 | -3.85 units on a scale | Standard Deviation 2.07 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Week 64 | Baseline | 6.96 units on a scale | Standard Deviation 1.08 |
Secondary
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 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).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.65 units on scale | Standard Error 0.08 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.25 units on scale | Standard Error 0.09 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.41 units on scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.73 units on scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.64 units on scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.56 units on scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.54 units on scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.44 units on scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.65 units on scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.48 units on scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.86 units on scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.68 units on scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.57 units on scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.49 units on scale | Standard Error 0.08 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.29 units on scale | Standard Error 0.09 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.37 units on scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.27 units on scale | Standard Error 0.1 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 4 | -1.98 units on scale | Standard Error 0.09 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.55 units on scale | Standard Error 0.08 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.67 units on scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.47 units on scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.52 units on scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.57 units on scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.42 units on 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.221295% CI: [-0.27, 0.06]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.455795% CI: [-0.1, 0.23]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.002995% CI: [-0.45, -0.09]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000595% CI: [-0.5, -0.14]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.127395% CI: [-0.33, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.57, -0.2]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.634995% CI: [-0.31, 0.19]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.133995% CI: [-0.44, 0.06]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.623795% CI: [-0.33, 0.2]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.422495% CI: [-0.37, 0.16]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.752695% CI: [-0.31, 0.22]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.732895% CI: [-0.31, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.588895% CI: [-0.33, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.934595% CI: [-0.28, 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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.878295% CI: [-0.29, 0.25]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, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.707695% CI: [-0.22, 0.32]ANCOVA
Secondary
Change From Baseline in WOMAC Physical Function Subscale at Week 64
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
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 who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Week 64 | Baseline | 7.09 units on a scale | Standard Deviation 1.07 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Week 64 | Change at Week 64 | -3.42 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Week 64 | Baseline | 7.08 units on a scale | Standard Deviation 1.11 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Week 64 | Change at Week 64 | -3.12 units on a scale | Standard Deviation 2.41 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Week 64 | Baseline | 6.99 units on a scale | Standard Deviation 1.09 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Week 64 | Change at Week 64 | -3.81 units on a scale | Standard Deviation 2.12 |
Secondary
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time frame: Baseline, Weeks 2, 4, 8, 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).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.76 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.29 units on a scale | Standard Error 0.09 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.46 units on a scale | Standard Error 0.1 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.78 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.66 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.56 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.56 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.45 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.69 units on a scale | Standard Error 0.1 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.49 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.88 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.67 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.57 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.64 units on a scale | Standard Error 0.08 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.31 units on a scale | Standard Error 0.09 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.36 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.27 units on a scale | Standard Error 0.1 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 4 | -1.96 units on a scale | Standard Error 0.09 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.55 units on a scale | Standard Error 0.08 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.66 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 48 | -2.45 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 40 | -2.50 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.55 units on a scale | Standard Error 0.13 |
| NSAID | Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 | Change at Week 56 | -2.41 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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.01595% CI: [-0.37, -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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.328695% CI: [-0.25, 0.08]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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000495% CI: [-0.5, -0.15]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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000195% CI: [-0.53, -0.17]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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.051795% CI: [-0.37, 0]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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.61, -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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.362195% CI: [-0.37, 0.13]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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.083295% CI: [-0.47, 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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.407295% CI: [-0.38, 0.15]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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.340495% CI: [-0.39, 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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.634495% CI: [-0.34, 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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.575695% CI: [-0.35, 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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.439495% CI: [-0.38, 0.16]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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.774795% CI: [-0.31, 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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.730595% CI: [-0.32, 0.22]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, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.73395% CI: [-0.22, 0.32]ANCOVA
Secondary
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (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.
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 who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64: Percent Activity Impairment | -28.7 units on a scale | Standard Deviation 26.68 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64: Percent Overall Work Impairment | -24.5 units on a scale | Standard Deviation 28.77 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Overall Work Impairment | 62.1 units on a scale | Standard Deviation 21.02 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64:Percent Impairment While Working | -24.2 units on a scale | Standard Deviation 27.69 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Work Time Missed | 6.1 units on a scale | Standard Deviation 15.81 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Activity Impairment | 68.3 units on a scale | Standard Deviation 14.93 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Impairment While Working | 60.5 units on a scale | Standard Deviation 20.39 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64: Percent Work Time Missed | -1.8 units on a scale | Standard Deviation 19.35 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Work Time Missed | 6.0 units on a scale | Standard Deviation 15.56 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64: Percent Work Time Missed | 4.1 units on a scale | Standard Deviation 21.88 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64: Percent Overall Work Impairment | -19.2 units on a scale | Standard Deviation 30.54 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64:Percent Impairment While Working | -20.7 units on a scale | Standard Deviation 29.13 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64: Percent Activity Impairment | -24.1 units on a scale | Standard Deviation 27.8 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Impairment While Working | 58.3 units on a scale | Standard Deviation 20.78 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Overall Work Impairment | 60.0 units on a scale | Standard Deviation 21.37 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Activity Impairment | 67.9 units on a scale | Standard Deviation 15.83 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64: Percent Activity Impairment | -32.1 units on a scale | Standard Deviation 24.51 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64: Percent Overall Work Impairment | -27.0 units on a scale | Standard Deviation 27.22 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Work Time Missed | 5.2 units on a scale | Standard Deviation 14.54 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Impairment While Working | 59.3 units on a scale | Standard Deviation 18.97 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Overall Work Impairment | 60.6 units on a scale | Standard Deviation 19.78 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Baseline: Percent Activity Impairment | 66.7 units on a scale | Standard Deviation 15.35 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64: Percent Work Time Missed | -2.1 units on a scale | Standard Deviation 16.65 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 | Change at Week 64:Percent Impairment While Working | -26.5 units on a scale | Standard Deviation 26.24 |
Secondary
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (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.
Time frame: Weeks 16, 24 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16: Percent Work Time Missed | -2.33 units on a scale | Standard Error 0.62 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16:Percent Impairment While Working | -28.07 units on a scale | Standard Error 1.58 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16: Percent Overall Work Impairment | -28.67 units on a scale | Standard Error 1.62 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16: Percent Activity Impairment | -30.59 units on a scale | Standard Error 1.04 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24: Percent Work Time Missed | -2.70 units on a scale | Standard Error 0.8 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24:Percent Impairment While Working | -25.34 units on a scale | Standard Error 1.73 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24: Percent Overall Work Impairment | -26.05 units on a scale | Standard Error 1.78 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24: Percent Activity Impairment | -29.88 units on a scale | Standard Error 1.13 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56: Percent Work Time Missed | -0.12 units on a scale | Standard Error 1.56 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56:Percent Impairment While Working | -31.49 units on a scale | Standard Error 2.22 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56: Percent Overall Work Impairment | -31.21 units on a scale | Standard Error 2.39 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56: Percent Activity Impairment | -34.47 units on a scale | Standard Error 1.42 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56: Percent Activity Impairment | -32.91 units on a scale | Standard Error 1.39 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16: Percent Work Time Missed | -3.35 units on a scale | Standard Error 0.64 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24: Percent Overall Work Impairment | -27.33 units on a scale | Standard Error 1.8 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56: Percent Work Time Missed | -1.84 units on a scale | Standard Error 1.47 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16:Percent Impairment While Working | -26.94 units on a scale | Standard Error 1.61 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24:Percent Impairment While Working | -26.66 units on a scale | Standard Error 1.74 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56: Percent Overall Work Impairment | -29.29 units on a scale | Standard Error 2.28 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16: Percent Overall Work Impairment | -27.51 units on a scale | Standard Error 1.65 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24: Percent Activity Impairment | -30.53 units on a scale | Standard Error 1.13 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24: Percent Work Time Missed | -2.19 units on a scale | Standard Error 0.81 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16: Percent Activity Impairment | -31.36 units on a scale | Standard Error 1.04 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56:Percent Impairment While Working | -29.92 units on a scale | Standard Error 2.12 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16: Percent Activity Impairment | -29.38 units on a scale | Standard Error 1.05 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24: Percent Work Time Missed | -2.73 units on a scale | Standard Error 0.81 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56:Percent Impairment While Working | -34.59 units on a scale | Standard Error 2.17 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24:Percent Impairment While Working | -25.15 units on a scale | Standard Error 1.74 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24: Percent Overall Work Impairment | -25.90 units on a scale | Standard Error 1.8 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 24: Percent Activity Impairment | -29.76 units on a scale | Standard Error 1.14 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56: Percent Overall Work Impairment | -34.26 units on a scale | Standard Error 2.34 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16: Percent Work Time Missed | -2.92 units on a scale | Standard Error 0.63 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16:Percent Impairment While Working | -26.59 units on a scale | Standard Error 1.6 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56: Percent Work Time Missed | -0.81 units on a scale | Standard Error 1.53 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 16: Percent Overall Work Impairment | -27.04 units on a scale | Standard Error 1.63 |
| NSAID | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 | Change at Week 56: Percent Activity Impairment | -36.17 units on a scale | Standard Error 1.41 |
Comparison: Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.430395% CI: [-0.87, 2.04]ANCOVA
Comparison: Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.565695% CI: [-1.9, 1.04]ANCOVA
Comparison: Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.97695% CI: [-1.78, 1.83]ANCOVA
Comparison: Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.567895% CI: [-1.3, 2.36]ANCOVA
Comparison: Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.697495% CI: [-2.77, 4.14]ANCOVA
Comparison: Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.126195% CI: [-0.75, 6.04]ANCOVA
Comparison: Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.40695% CI: [-4.96, 2.01]ANCOVA
Comparison: Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.84895% CI: [-3.84, 3.15]ANCOVA
Comparison: Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.92395% CI: [-4, 3.63]ANCOVA
Comparison: Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.442195% CI: [-5.36, 2.34]ANCOVA
Comparison: Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.204995% CI: [-1.7, 7.91]ANCOVA
Comparison: Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.052795% CI: [-0.05, 9.41]ANCOVA
Comparison: Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.369995% CI: [-5.21, 1.94]ANCOVA
Comparison: Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.794595% CI: [-4.06, 3.11]ANCOVA
Comparison: Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.94195% CI: [-4.13, 3.83]ANCOVA
Comparison: Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.48695% CI: [-5.44, 2.59]ANCOVA
Comparison: Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.244895% CI: [-2.1, 8.2]ANCOVA
Comparison: Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.055195% CI: [-0.11, 10.04]ANCOVA
Comparison: Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.24795% CI: [-3.26, 0.84]ANCOVA
Comparison: Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.05795% CI: [-4.01, 0.06]ANCOVA
Comparison: Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.91795% CI: [-2.36, 2.12]ANCOVA
Comparison: Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.499195% CI: [-3, 1.46]ANCOVA
Comparison: Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.237795% CI: [-1.12, 4.52]ANCOVA
Comparison: Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.023895% CI: [0.43, 6.08]ANCOVA
Secondary
European Quality of Life-5 Dimensions-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 two 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. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (\<=) 1. The 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 is reduced where a participant reports greater levels of problems across the 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, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 8 | 0.74 units on a scale | Standard Deviation 0.12 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 40 | 0.79 units on a scale | Standard Deviation 0.13 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 24 | 0.76 units on a scale | Standard Deviation 0.14 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Baseline | 0.61 units on a scale | Standard Deviation 0.14 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 64 | 0.72 units on a scale | Standard Deviation 0.15 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 56 | 0.78 units on a scale | Standard Deviation 0.12 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 16 | 0.77 units on a scale | Standard Deviation 0.12 |
| Tanezumab 5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 24 | 0.76 units on a scale | Standard Deviation 0.15 |
| Tanezumab 5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Baseline | 0.61 units on a scale | Standard Deviation 0.14 |
| Tanezumab 5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 8 | 0.75 units on a scale | Standard Deviation 0.13 |
| Tanezumab 5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 16 | 0.78 units on a scale | Standard Deviation 0.13 |
| Tanezumab 5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 40 | 0.78 units on a scale | Standard Deviation 0.15 |
| Tanezumab 5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 56 | 0.77 units on a scale | Standard Deviation 0.15 |
| Tanezumab 5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 64 | 0.69 units on a scale | Standard Deviation 0.16 |
| NSAID | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 40 | 0.80 units on a scale | Standard Deviation 0.12 |
| NSAID | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 8 | 0.74 units on a scale | Standard Deviation 0.13 |
| NSAID | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 64 | 0.75 units on a scale | Standard Deviation 0.13 |
| NSAID | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 56 | 0.79 units on a scale | Standard Deviation 0.12 |
| NSAID | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 24 | 0.77 units on a scale | Standard Deviation 0.14 |
| NSAID | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 16 | 0.77 units on a scale | Standard Deviation 0.13 |
| NSAID | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Baseline | 0.62 units on a scale | Standard Deviation 0.13 |
Secondary
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA.
Time frame: Baseline, Weeks 64 and 80
Population: ITT population was analyzed. One additional participant apart from the ones who had responded for quitting job responded to duration since quitting job. Here 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 64 | 2.4 years |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline | 2.0 years |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 80 | 2.0 years |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 64 | 1.8 years |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline | 1.8 years |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 80 | 2.0 years |
| NSAID | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline | 2.4 years |
| NSAID | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 80 | 1.8 years |
| NSAID | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 64 | 4.0 years |
Secondary
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA.
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 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 64 | 2.0 nights |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Baseline | 12.0 nights |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 80 | 2.0 nights |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 80 | 2.0 nights |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Baseline | 9.0 nights |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 64 | 2.0 nights |
| NSAID | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 64 | 2.0 nights |
| NSAID | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Baseline | 11.0 nights |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA.
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 who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 64 | 5 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline | 11 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 80 | 8 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 64 | 11 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline | 6 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 80 | 12 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline | 1 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 80 | 0 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 64 | 6 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA.
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 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 64 | 28 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Baseline | 47 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 80 | 12 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 64 | 35 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Baseline | 55 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 80 | 18 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Baseline | 65 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 80 | 6 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 64 | 26 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). 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, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Never | 662 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Sometimes | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Never | 373 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Rarely | 21 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Sometimes | 5 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Always | 3 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Sometimes | 48 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Never | 852 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Often | 12 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Often | 20 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Often | 3 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Sometimes | 19 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Always | 22 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Often | 32 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Rarely | 6 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Never | 765 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Sometimes | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Never | 733 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Rarely | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Always | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Always | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Sometimes | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Always | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Often | 3 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Often | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Sometimes | 7 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Always | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Never | 970 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Rarely | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Never | 760 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Rarely | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Never | 425 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Rarely | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Always | 19 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Always | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Sometimes | 7 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Often | 5 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Often | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Often | 16 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Never | 416 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Sometimes | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Always | 6 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Never | 992 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Never | 932 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Sometimes | 71 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Never | 430 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Rarely | 8 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Always | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Always | 8 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Sometimes | 27 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Rarely | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Often | 14 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Often | 27 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Rarely | 27 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Sometimes | 25 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Always | 7 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Often | 3 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Rarely | 12 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Sometimes | 6 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Never | 838 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Rarely | 18 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Sometimes | 69 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Often | 43 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Always | 29 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Never | 989 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Rarely | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Sometimes | 6 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Often | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Always | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Never | 976 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Rarely | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Sometimes | 6 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Often | 9 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Always | 5 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Never | 935 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Rarely | 7 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Sometimes | 22 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Often | 22 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Always | 11 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Never | 662 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Rarely | 9 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Sometimes | 47 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Often | 30 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Always | 34 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Never | 776 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Rarely | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Sometimes | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Often | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Always | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Never | 768 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Rarely | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Sometimes | 7 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Often | 5 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Always | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Never | 720 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Rarely | 9 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Sometimes | 26 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Often | 20 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Always | 7 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Never | 322 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Rarely | 10 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Sometimes | 25 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Often | 17 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Always | 22 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Never | 389 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Rarely | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Sometimes | 4 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Often | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Always | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Never | 383 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Rarely | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Often | 5 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Always | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Never | 375 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Rarely | 3 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Sometimes | 11 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Often | 4 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Always | 3 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Never | 714 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Often | 0 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Never | 386 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Always | 10 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Never | 988 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Rarely | 6 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Often | 14 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Rarely | 24 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Sometimes | 17 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Sometimes | 41 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Always | 0 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Often | 7 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Rarely | 9 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Always | 19 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Walking Aid Use | Always | 8 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Other Aids Or Devices | Never | 921 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Always | 4 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Never | 421 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Always | 5 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Never | 410 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Rarely | 2 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Often | 7 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Often | 26 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Sometimes | 1 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Sometimes | 6 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Often | 2 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Often | 0 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Rarely | 0 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Rarely | 4 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Wheelchair Use | Always | 0 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Device/Utensil to Dress Bathe Eat | Never | 977 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Sometimes | 75 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Never | 792 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Always | 0 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Never | 422 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Rarely | 1 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Often | 0 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Always | 0 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Sometimes | 2 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Sometimes | 3 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Walking Aid Use | Never | 851 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Often | 2 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Rarely | 2 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Rarely | 1 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Device/Utensil to Dress Bathe Eat | Always | 2 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Wheelchair Use | Never | 794 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Often | 1 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Never | 771 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Always | 19 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Sometimes | 5 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Rarely | 11 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Often | 17 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Device/Utensil to Dress Bathe Eat | Sometimes | 1 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Sometimes | 8 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Sometimes | 37 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Baseline: Wheelchair Use | Rarely | 1 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Often | 6 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Walking Aid Use | Rarely | 12 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 80: Other Aids Or Devices | Sometimes | 4 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | Week 64: Other Aids Or Devices | Always | 3 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA.
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 who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 64 | 10 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline | 15 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 80 | 4 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 64 | 15 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline | 23 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 80 | 5 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline | 11 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 80 | 2 Participants |
| NSAID | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 64 | 5 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA 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.
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 signifies those participants who were evaluable at specified time point for this outcome measure for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Other Practitioner | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Pain Specialist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Orthopedist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Physical Therapist | 4.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Chiropractor | 3.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Alternative Medicine or Therapy | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Podiatrist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Nutritionist/Dietitian | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Radiologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Home Healthcare Services | 4.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Physician Assistant Or Nurse Practitioner | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Primary Care Physician | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Neurologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Rheumatologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Physician Assistant or Nurse Practitioner | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Pain Specialist | 1.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Orthopedist | 1.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Physical Therapist | 8.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Chiropractor | 3.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Alternative Medicine or Therapy | 3.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Podiatrist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Nutritionist/Dietitian | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Radiologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Home Healthcare Services | 2.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Other Practitioner | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Primary Care Physician | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Neurologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Rheumatologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Physician Assistant or Nurse Practitioner | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Pain Specialist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Orthopedist | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Physical Therapist | 4.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Chiropractor | 3.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Alternative Medicine or Therapy | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Podiatrist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Nutritionist/Dietitian | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Radiologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Home Healthcare Services | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Other Practitioner | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Primary Care Physician | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Neurologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Rheumatologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Orthopedist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Physician Assistant or Nurse Practitioner | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Pain Specialist | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Alternative Medicine or Therapy | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Orthopedist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Physical Therapist | 5.5 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Primary Care Physician | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Chiropractor | 4.5 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Podiatrist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Alternative Medicine or Therapy | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Podiatrist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Nutritionist/Dietitian | 1.5 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Nutritionist/Dietitian | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Radiologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Home Healthcare Services | 4.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Rheumatologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Other Practitioner | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Radiologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Primary Care Physician | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Neurologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Neurologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Rheumatologist | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Home Healthcare Services | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Physician Assistant Or Nurse Practitioner | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Physician Assistant or Nurse Practitioner | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Pain Specialist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Orthopedist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Physical Therapist | 4.5 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Pain Specialist | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Chiropractor | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Alternative Medicine or Therapy | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Podiatrist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Nutritionist/Dietitian | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Radiologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Other Practitioner | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Home Healthcare Services | 4.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Physical Therapist | 3.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Other Practitioner | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Primary Care Physician | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Neurologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Chiropractor | 3.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Rheumatologist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Other Practitioner | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Nutritionist/Dietitian | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Physician Assistant or Nurse Practitioner | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Rheumatologist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Physician Assistant Or Nurse Practitioner | 2.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Pain Specialist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Orthopedist | 2.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Physical Therapist | 3.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Orthopedist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Alternative Medicine or Therapy | 2.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Pain Specialist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Physical Therapist | 3.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Physician Assistant or Nurse Practitioner | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Radiologist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Chiropractor | 3.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Orthopedist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Home Healthcare Services | 3.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Alternative Medicine or Therapy | 2.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Podiatrist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Neurologist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Podiatrist | 3.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Primary Care Physician | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Physical Therapist | 3.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Nutritionist/Dietitian | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Primary Care Physician | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Home Healthcare Services | 5.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Radiologist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Nutritionist/Dietitian | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Chiropractor | 3.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Home Healthcare Services | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Pain Specialist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Other Practitioner | 2.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Other Practitioner | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Alternative Medicine or Therapy | 2.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Neurologist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Primary Care Physician | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Radiologist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 80: Rheumatologist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Neurologist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 64: Podiatrist | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Chiropractor | 3.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Rheumatologist | 2.0 visits |
Secondary
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA.
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 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 64 | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 80 | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 64 | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 80 | 3.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 80 | 1.0 visits |
| NSAID | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 64 | 1.0 visits |
Secondary
Number of Days of Rescue Medication Used During Week 64
In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 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' = participants who took rescue medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Week 64 | 2.0 days | Standard Deviation 2.38 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Week 64 | 2.3 days | Standard Deviation 2.46 |
| NSAID | Number of Days of Rescue Medication Used During Week 64 | 1.7 days | Standard Deviation 2.26 |
Secondary
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.
Time frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 16 | 1.29 days | Standard Error 0.11 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 56 | 1.73 days | Standard Error 0.13 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 32 | 1.67 days | Standard Error 0.13 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 24 | 1.56 days | Standard Error 0.12 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 2 | 2.31 days | Standard Error 0.13 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 48 | 1.68 days | Standard Error 0.13 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 8 | 1.65 days | Standard Error 0.12 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 4 | 1.80 days | Standard Error 0.12 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 40 | 1.70 days | Standard Error 0.13 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 24 | 1.56 days | Standard Error 0.13 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 2 | 2.29 days | Standard Error 0.13 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 4 | 1.70 days | Standard Error 0.11 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 8 | 1.42 days | Standard Error 0.11 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 16 | 1.25 days | Standard Error 0.1 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 32 | 1.66 days | Standard Error 0.13 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 40 | 1.71 days | Standard Error 0.13 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 48 | 1.76 days | Standard Error 0.14 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 56 | 1.85 days | Standard Error 0.14 |
| NSAID | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 8 | 1.65 days | Standard Error 0.12 |
| NSAID | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 2 | 2.26 days | Standard Error 0.13 |
| NSAID | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 40 | 1.76 days | Standard Error 0.13 |
| NSAID | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 4 | 1.86 days | Standard Error 0.12 |
| NSAID | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 56 | 1.74 days | Standard Error 0.13 |
| NSAID | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 24 | 1.65 days | Standard Error 0.13 |
| NSAID | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 16 | 1.39 days | Standard Error 0.11 |
| NSAID | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 48 | 1.74 days | Standard Error 0.13 |
| NSAID | Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 32 | 1.78 days | Standard Error 0.13 |
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.774695% CI: [0.89, 1.16]Negative binomial model
Comparison: Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.844195% CI: [0.89, 1.16]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.65895% CI: [0.83, 1.13]Negative binomial model
Comparison: Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.227995% CI: [0.78, 1.06]Negative binomial model
Comparison: Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.542695% CI: [0.79, 1.13]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.998695% CI: [0.84, 1.18]Negative binomial model
Comparison: Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.077195% CI: [0.72, 1.02]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.448595% CI: [0.77, 1.13]Negative binomial model
Comparison: Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.281795% CI: [0.74, 1.09]Negative binomial model
Comparison: Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.538595% CI: [0.79, 1.13]Negative binomial model
Comparison: Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.504195% CI: [0.79, 1.12]Negative binomial model
Comparison: Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.44195% CI: [0.78, 1.11]Negative binomial model
Comparison: Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.742695% CI: [0.81, 1.16]Negative binomial model
Comparison: Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.746995% CI: [0.81, 1.16]Negative binomial model
Comparison: Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.678495% CI: [0.81, 1.15]Negative binomial model
Comparison: Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.882295% CI: [0.85, 1.21]Negative binomial model
Comparison: Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.911995% CI: [0.83, 1.18]Negative binomial model
Comparison: Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.p-value: 0.514895% CI: [0.89, 1.26]Negative binomial model
Secondary
Number of Participants Who Took Rescue Medication During Week 64
In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 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 Week 64 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' = participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Week 64 | 251 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Week 64 | 268 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Week 64 | 215 Participants |
Secondary
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.
Time frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 16 | 353 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 56 | 391 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 32 | 391 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 24 | 372 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 2 | 567 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 48 | 391 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 8 | 433 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 4 | 481 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 40 | 391 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 24 | 358 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 2 | 548 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 4 | 437 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 8 | 377 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 16 | 330 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 32 | 380 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 40 | 388 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 48 | 393 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 56 | 408 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 8 | 418 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 2 | 527 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 40 | 388 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 4 | 469 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 56 | 397 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 24 | 384 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 16 | 352 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 48 | 389 Participants |
| NSAID | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Week 32 | 390 Participants |
Comparison: Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.113695% CI: [0.97, 1.38]Regression, Logistic
Comparison: Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.39195% CI: [0.9, 1.29]Regression, Logistic
Comparison: Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.769195% CI: [0.86, 1.22]Regression, Logistic
Comparison: Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.14395% CI: [0.73, 1.05]Regression, Logistic
Comparison: Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.645495% CI: [0.87, 1.25]Regression, Logistic
Comparison: Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.056195% CI: [0.7, 1]Regression, Logistic
Comparison: Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.905695% CI: [0.82, 1.19]Regression, Logistic
Comparison: Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.291995% CI: [0.75, 1.09]Regression, Logistic
Comparison: Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.497695% CI: [0.78, 1.13]Regression, Logistic
Comparison: Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.242595% CI: [0.75, 1.08]Regression, Logistic
Comparison: Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.924295% CI: [0.83, 1.19]Regression, Logistic
Comparison: Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.662195% CI: [0.8, 1.15]Regression, Logistic
Comparison: Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.997795% CI: [0.83, 1.2]Regression, Logistic
Comparison: Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.976295% CI: [0.84, 1.2]Regression, Logistic
Comparison: Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.971895% CI: [0.83, 1.19]Regression, Logistic
Comparison: Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.821995% CI: [0.85, 1.22]Regression, Logistic
Comparison: Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.693695% CI: [0.8, 1.16]Regression, Logistic
Comparison: Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.576995% CI: [0.88, 1.26]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) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 60 Participants |
| Tanezumab 5 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 63 Participants |
| NSAID | Number of Participants Who Withdrew Due to Lack of Efficacy | 91 Participants |
Comparison: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.007695% CI: [0.45, 0.88]Regression, Logistic
Comparison: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.018795% CI: [0.48, 0.94]Regression, Logistic
Secondary
Number of Participants With Anti-Tanezumab Antibodies
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).
Time frame: Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Baseline | 116 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 8 | 120 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 16 | 98 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 32 | 108 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 48 | 96 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 56 | 82 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 64 | 69 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 80 | 50 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 80 | 42 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Tanezumab Antibodies | Baseline | 83 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 48 | 78 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 8 | 93 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 64 | 60 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 16 | 83 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 56 | 66 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 32 | 81 Participants |
Secondary
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80
The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change \>0), No change and worsening (Change less than \[\<\] 0).
Time frame: Baseline, Weeks 4, 8, 16, 24, 56 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 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 8 | No Change | 325 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 4 | No Change | 370 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 4 | Worsening | 207 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 8 | Improvement | 454 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 4 | Improvement | 423 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 8 | Worsening | 221 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 16 | Improvement | 488 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 16 | No Change | 288 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 16 | Worsening | 224 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 24 | Improvement | 478 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 24 | No Change | 277 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 24 | Worsening | 245 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 56 | Improvement | 486 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 56 | No Change | 270 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 56 | Worsening | 244 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 80 | Improvement | 220 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 80 | No Change | 105 Participants |
| Tanezumab 2.5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 80 | Worsening | 113 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 80 | Worsening | 115 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 4 | Improvement | 421 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 24 | Improvement | 458 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 56 | Improvement | 429 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 4 | No Change | 394 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 56 | Worsening | 252 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 80 | Improvement | 196 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 4 | Worsening | 180 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 24 | No Change | 302 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 80 | No Change | 97 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 8 | Improvement | 443 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 16 | Worsening | 213 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 56 | No Change | 314 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 8 | No Change | 362 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 16 | No Change | 312 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 24 | Worsening | 235 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 8 | Worsening | 190 Participants |
| Tanezumab 5 mg | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 16 | Improvement | 470 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 8 | Worsening | 201 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 16 | Improvement | 477 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 16 | No Change | 312 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 56 | Worsening | 233 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 16 | Worsening | 205 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 80 | Worsening | 80 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 24 | Improvement | 467 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 24 | No Change | 291 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 80 | Improvement | 227 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 24 | Worsening | 236 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 4 | Improvement | 411 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 4 | No Change | 369 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 56 | Improvement | 461 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 4 | Worsening | 214 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 8 | Improvement | 445 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 8 | No Change | 348 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 56 | No Change | 300 Participants |
| NSAID | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 | Change at Week 80 | No Change | 125 Participants |
Comparison: Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.6037Cochran-Mantel-Haenszel
Comparison: Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.1928Cochran-Mantel-Haenszel
Comparison: Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.7204Cochran-Mantel-Haenszel
Comparison: Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.7969Cochran-Mantel-Haenszel
Comparison: Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.7857Cochran-Mantel-Haenszel
Comparison: Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.6627Cochran-Mantel-Haenszel
Comparison: Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.9867Cochran-Mantel-Haenszel
Comparison: Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.819Cochran-Mantel-Haenszel
Comparison: Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.7284Cochran-Mantel-Haenszel
Comparison: Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.1545Cochran-Mantel-Haenszel
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.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 40 | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 56 | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 64 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 80 | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 80 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 3 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 64 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 40 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 56 | 1 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 1 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 0 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 56 | 1 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 1 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 0 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 40 | 1 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 64 | 3 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 2 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 0 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 1 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 80 | 0 Participants |
| NSAID | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 2 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, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes \<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; specific gravity\<1.003, \>1.030; Urine erythrocytes,Leukocytes\>=20; Hyaline Casts\>=1.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC. Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 78 Participants |
| Tanezumab 5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 61 Participants |
| NSAID | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 84 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; Leukocytes \<0.6\*LLN, \>1.5\*ULN; Lymphocytes, 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 erythrocytes,Leukocytes\>=20.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC. Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 109 Participants |
| Tanezumab 5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 102 Participants |
| NSAID | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 121 Participants |
Secondary
Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW \>=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
Time frame: Weeks 56 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure, and Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Week 56 | 10 Participants |
| Tanezumab 2.5 mg | Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Week 80 | 9 Participants |
| Tanezumab 5 mg | Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Week 56 | 10 Participants |
| Tanezumab 5 mg | Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Week 80 | 9 Participants |
| NSAID | Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Week 56 | 3 Participants |
| NSAID | Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Week 80 | 3 Participants |
Comparison: Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariatep-value: 0.071495% CI: [0.9, 12.65]Regression, Logistic
Comparison: Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariatep-value: 0.068195% CI: [0.91, 12.84]Regression, Logistic
Comparison: Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariatep-value: 0.096795% CI: [0.81, 11.95]Regression, Logistic
Comparison: Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariatep-value: 0.097695% CI: [0.81, 11.9]Regression, Logistic
Secondary
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
Progression of OA according to Bland-Altman as defined by a decrease JSW \>=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 \[no radiographic features of OA\], 1 \[doubtful joint space narrowing (JSN) and possible osteophytic lipping\], 2 \[definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph\], 3 \[multiple osteophytes, definite JSN, sclerosis, possible bony deformity\], 4 \[large osteophytes, marked JSN, severe sclerosis and definite bony deformity\]. Higher grade indicating worse knee function.
Time frame: Weeks 56 and 80
Population: Safety population included all participants treated with tanezumab or placebo SC. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure, and Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased medial JSW at Week 56 | 33 Participants |
| Tanezumab 2.5 mg | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased medial JSW at Week 80 | 29 Participants |
| Tanezumab 2.5 mg | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased lateral JSW at Week 56 | 5 Participants |
| Tanezumab 2.5 mg | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased lateral JSW at Week 80 | 9 Participants |
| Tanezumab 5 mg | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased lateral JSW at Week 80 | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased medial JSW at Week 56 | 43 Participants |
| Tanezumab 5 mg | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased lateral JSW at Week 56 | 8 Participants |
| Tanezumab 5 mg | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased medial JSW at Week 80 | 38 Participants |
| NSAID | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased lateral JSW at Week 80 | 7 Participants |
| NSAID | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased medial JSW at Week 80 | 16 Participants |
| NSAID | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased lateral JSW at Week 56 | 9 Participants |
| NSAID | Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 | Decreased medial JSW at Week 56 | 20 Participants |
Comparison: Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.p-value: 0.035895% CI: [1.04, 3.29]Regression, Logistic
Comparison: Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.p-value: 0.002195% CI: [1.37, 4.12]Regression, Logistic
Comparison: Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.p-value: 0.030195% CI: [1.07, 3.77]Regression, Logistic
Comparison: Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.p-value: 0.001695% CI: [1.45, 4.85]Regression, Logistic
Comparison: Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.p-value: 0.300295% CI: [0.18, 1.7]Regression, Logistic
Comparison: Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.p-value: 0.899795% CI: [0.39, 2.89]Regression, Logistic
Comparison: Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.p-value: 0.455995% CI: [0.53, 4.18]Regression, Logistic
Comparison: Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.p-value: 0.599695% CI: [0.2, 2.54]Regression, Logistic
Secondary
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain
Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the 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, Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Extremely anxious or depressed | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Moderately anxious or depressed | 53 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Severely anxious or depressed | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Severely anxious or depressed | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Severely anxious or depressed | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Not anxious or depressed | 560 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Moderately anxious or depressed | 24 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Extremely anxious or depressed | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Not anxious or depressed | 693 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Slightly anxious or depressed | 92 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Not anxious or depressed | 611 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Moderately anxious or depressed | 155 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Not anxious or depressed | 442 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Slightly anxious or depressed | 147 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Not anxious or depressed | 308 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Extremely anxious or depressed | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Moderately anxious or depressed | 52 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Slightly anxious or depressed | 189 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Severely anxious or depressed | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Slightly anxious or depressed | 252 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Extremely anxious or depressed | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Moderately anxious or depressed | 64 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Moderately anxious or depressed | 29 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Severely anxious or depressed | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Severely anxious or depressed | 9 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Severely anxious or depressed | 28 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Moderately anxious or depressed | 18 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Extremely anxious or depressed | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Extremely anxious or depressed | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Slightly anxious or depressed | 88 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Not anxious or depressed | 680 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Slightly anxious or depressed | 104 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Not anxious or depressed | 351 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Slightly anxious or depressed | 170 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Extremely anxious or depressed | 5 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Not anxious or depressed | 275 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Not anxious or depressed | 570 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Slightly anxious or depressed | 235 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Moderately anxious or depressed | 151 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Severely anxious or depressed | 37 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Extremely anxious or depressed | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Not anxious or depressed | 703 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Slightly anxious or depressed | 180 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Moderately anxious or depressed | 71 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Severely anxious or depressed | 7 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Extremely anxious or depressed | 5 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Not anxious or depressed | 701 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Slightly anxious or depressed | 147 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Moderately anxious or depressed | 62 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Severely anxious or depressed | 6 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Extremely anxious or depressed | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Not anxious or depressed | 606 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Slightly anxious or depressed | 131 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Moderately anxious or depressed | 66 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Severely anxious or depressed | 10 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Extremely anxious or depressed | 3 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Not anxious or depressed | 429 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Slightly anxious or depressed | 82 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Moderately anxious or depressed | 35 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Severely anxious or depressed | 6 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Extremely anxious or depressed | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Not anxious or depressed | 330 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Slightly anxious or depressed | 90 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Moderately anxious or depressed | 33 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Severely anxious or depressed | 3 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Extremely anxious or depressed | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Slightly anxious or depressed | 96 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Moderately anxious or depressed | 46 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Severely anxious or depressed | 9 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Extremely anxious or depressed | 2 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Severely anxious or depressed | 5 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Severely anxious or depressed | 7 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Slightly anxious or depressed | 151 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Slightly anxious or depressed | 100 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Extremely anxious or depressed | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Not anxious or depressed | 701 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Moderately anxious or depressed | 144 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Not anxious or depressed | 338 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Extremely anxious or depressed | 2 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Not anxious or depressed | 585 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Slightly anxious or depressed | 86 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Severely anxious or depressed | 9 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Moderately anxious or depressed | 34 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Moderately anxious or depressed | 34 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Moderately anxious or depressed | 75 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Slightly anxious or depressed | 236 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Severely anxious or depressed | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Slightly anxious or depressed | 206 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Extremely anxious or depressed | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Moderately anxious or depressed | 58 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 56 | Extremely anxious or depressed | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Severely anxious or depressed | 11 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Slightly anxious or depressed | 144 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 8 | Not anxious or depressed | 664 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Extremely anxious or depressed | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 24 | Not anxious or depressed | 599 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Extremely anxious or depressed | 3 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Not anxious or depressed | 400 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Extremely anxious or depressed | 2 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 64 | Not anxious or depressed | 315 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Slightly anxious or depressed | 107 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Severely anxious or depressed | 8 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Baseline | Severely anxious or depressed | 26 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 40 | Moderately anxious or depressed | 21 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | Week 16 | Moderately anxious or depressed | 53 Participants |
Secondary
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain
Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the 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, Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Unable to walk | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Moderate problem in walking | 199 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Unable to walk | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Severe problem in walking | 19 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Severe problem in walking | 27 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Severe problem in walking | 45 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Moderate problem in walking | 110 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Unable to walk | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | No problem in walking | 223 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Slight problem in walking | 215 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | No problem in walking | 259 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Moderate problem in walking | 567 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | No problem in walking | 217 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Slight problem in walking | 308 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | No problem in walking | 98 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Unable to walk | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Moderate problem in walking | 216 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Slight problem in walking | 374 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Severe problem in walking | 34 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Slight problem in walking | 203 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Unable to walk | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Moderate problem in walking | 318 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Moderate problem in walking | 150 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Severe problem in walking | 19 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Severe problem in walking | 41 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Slight problem in walking | 156 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Moderate problem in walking | 77 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Unable to walk | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Severe problem in walking | 204 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Slight problem in walking | 205 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | No problem in walking | 299 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Unable to walk | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | No problem in walking | 157 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Slight problem in walking | 388 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | No problem in walking | 26 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | No problem in walking | 66 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | No problem in walking | 20 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Slight problem in walking | 192 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Moderate problem in walking | 579 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Severe problem in walking | 202 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Unable to walk | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | No problem in walking | 241 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Slight problem in walking | 411 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Moderate problem in walking | 266 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Severe problem in walking | 48 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Unable to walk | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | No problem in walking | 319 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Slight problem in walking | 371 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Moderate problem in walking | 196 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Severe problem in walking | 34 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Unable to walk | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | No problem in walking | 261 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Slight problem in walking | 310 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Moderate problem in walking | 200 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Severe problem in walking | 43 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Unable to walk | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | No problem in walking | 211 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Slight problem in walking | 209 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Moderate problem in walking | 106 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Severe problem in walking | 27 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Unable to walk | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | No problem in walking | 147 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Slight problem in walking | 166 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Moderate problem in walking | 120 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Severe problem in walking | 24 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Unable to walk | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Slight problem in walking | 156 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Moderate problem in walking | 151 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Severe problem in walking | 54 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Unable to walk | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Severe problem in walking | 21 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Severe problem in walking | 9 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Slight problem in walking | 412 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Slight problem in walking | 205 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Unable to walk | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | No problem in walking | 292 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Unable to walk | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | No problem in walking | 170 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Unable to walk | 3 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | No problem in walking | 23 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Slight problem in walking | 189 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Severe problem in walking | 44 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Moderate problem in walking | 121 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Moderate problem in walking | 91 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Moderate problem in walking | 301 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Slight problem in walking | 194 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Severe problem in walking | 9 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | Slight problem in walking | 392 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | Unable to walk | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Moderate problem in walking | 186 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 56 | Unable to walk | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Severe problem in walking | 29 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Slight problem in walking | 337 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 8 | No problem in walking | 216 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | Unable to walk | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 24 | No problem in walking | 260 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Severe problem in walking | 189 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | No problem in walking | 218 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Unable to walk | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 64 | No problem in walking | 107 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Slight problem in walking | 217 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Severe problem in walking | 26 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Baseline | Moderate problem in walking | 588 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 40 | Moderate problem in walking | 91 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | Week 16 | Moderate problem in walking | 185 Participants |
Secondary
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain
Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the 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, Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Extreme pain or discomfort | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Moderate pain or discomfort | 235 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Severe pain or discomfort | 66 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Severe pain or discomfort | 25 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Severe pain or discomfort | 39 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | No pain or discomfort | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Moderate pain or discomfort | 139 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Extreme pain or discomfort | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | No pain or discomfort | 82 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Slight pain or discomfort | 298 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | No pain or discomfort | 117 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Moderate pain or discomfort | 548 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | No pain or discomfort | 97 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Slight pain or discomfort | 413 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | No pain or discomfort | 45 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Extreme pain or discomfort | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Moderate pain or discomfort | 213 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Slight pain or discomfort | 433 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Severe pain or discomfort | 70 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Slight pain or discomfort | 81 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Extreme pain or discomfort | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Moderate pain or discomfort | 369 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Moderate pain or discomfort | 165 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Severe pain or discomfort | 23 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Severe pain or discomfort | 68 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Severe pain or discomfort | 334 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Moderate pain or discomfort | 111 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Extreme pain or discomfort | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Extreme pain or discomfort | 5 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Slight pain or discomfort | 248 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | No pain or discomfort | 128 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Slight pain or discomfort | 169 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | No pain or discomfort | 76 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Slight pain or discomfort | 508 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Extreme pain or discomfort | 31 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | No pain or discomfort | 35 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | No pain or discomfort | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Slight pain or discomfort | 75 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Moderate pain or discomfort | 574 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Severe pain or discomfort | 314 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Extreme pain or discomfort | 28 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | No pain or discomfort | 102 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Slight pain or discomfort | 465 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Moderate pain or discomfort | 327 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Severe pain or discomfort | 68 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Extreme pain or discomfort | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | No pain or discomfort | 163 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Slight pain or discomfort | 482 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Moderate pain or discomfort | 225 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Severe pain or discomfort | 44 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Extreme pain or discomfort | 6 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | No pain or discomfort | 148 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Slight pain or discomfort | 384 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Moderate pain or discomfort | 218 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Severe pain or discomfort | 62 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Extreme pain or discomfort | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | No pain or discomfort | 122 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Slight pain or discomfort | 264 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Moderate pain or discomfort | 130 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Severe pain or discomfort | 30 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Extreme pain or discomfort | 7 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | No pain or discomfort | 90 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Slight pain or discomfort | 211 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Moderate pain or discomfort | 128 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Severe pain or discomfort | 26 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Extreme pain or discomfort | 3 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Slight pain or discomfort | 115 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Moderate pain or discomfort | 191 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Severe pain or discomfort | 76 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Extreme pain or discomfort | 11 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Severe pain or discomfort | 29 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Severe pain or discomfort | 13 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Slight pain or discomfort | 515 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Slight pain or discomfort | 191 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Extreme pain or discomfort | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | No pain or discomfort | 131 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Moderate pain or discomfort | 588 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | No pain or discomfort | 85 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Extreme pain or discomfort | 3 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | No pain or discomfort | 5 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Slight pain or discomfort | 259 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Severe pain or discomfort | 71 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Moderate pain or discomfort | 171 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Moderate pain or discomfort | 103 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Moderate pain or discomfort | 365 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Slight pain or discomfort | 86 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Severe pain or discomfort | 9 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | Slight pain or discomfort | 434 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | Extreme pain or discomfort | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Moderate pain or discomfort | 215 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 56 | Extreme pain or discomfort | 3 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Severe pain or discomfort | 51 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Slight pain or discomfort | 413 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 8 | No pain or discomfort | 83 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | Extreme pain or discomfort | 4 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 24 | No pain or discomfort | 130 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Extreme pain or discomfort | 20 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | No pain or discomfort | 110 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Extreme pain or discomfort | 6 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 64 | No pain or discomfort | 62 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Slight pain or discomfort | 308 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Severe pain or discomfort | 46 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Baseline | Severe pain or discomfort | 295 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 40 | Moderate pain or discomfort | 104 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | Week 16 | Moderate pain or discomfort | 217 Participants |
Secondary
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain
Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the 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, Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Unable to wash or dress | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Moderate problems washing or dressing | 81 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Severe problems washing or dressing | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Severe problems washing or dressing | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Severe problems washing or dressing | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | No problems washing or dressing | 251 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Moderate problems washing or dressing | 42 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Unable to wash or dress | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | No problems washing or dressing | 551 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Slight problems washing or dressing | 140 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | No problems washing or dressing | 504 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Moderate problems washing or dressing | 361 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | No problems washing or dressing | 377 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Slight problems washing or dressing | 214 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | No problems washing or dressing | 233 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Unable to wash or dress | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Moderate problems washing or dressing | 91 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Slight problems washing or dressing | 270 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Severe problems washing or dressing | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Slight problems washing or dressing | 315 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Unable to wash or dress | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Moderate problems washing or dressing | 126 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Moderate problems washing or dressing | 66 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Severe problems washing or dressing | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Severe problems washing or dressing | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Severe problems washing or dressing | 73 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Moderate problems washing or dressing | 42 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Unable to wash or dress | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Unable to wash or dress | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Slight problems washing or dressing | 107 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | No problems washing or dressing | 610 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Slight problems washing or dressing | 142 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | No problems washing or dressing | 305 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Slight problems washing or dressing | 216 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Unable to wash or dress | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | No problems washing or dressing | 192 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | No problems washing or dressing | 242 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Slight problems washing or dressing | 295 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Moderate problems washing or dressing | 389 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Severe problems washing or dressing | 69 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Unable to wash or dress | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | No problems washing or dressing | 569 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Slight problems washing or dressing | 261 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Moderate problems washing or dressing | 128 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Severe problems washing or dressing | 8 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Unable to wash or dress | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | No problems washing or dressing | 597 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Slight problems washing or dressing | 231 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Moderate problems washing or dressing | 87 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Severe problems washing or dressing | 5 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Unable to wash or dress | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | No problems washing or dressing | 504 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Slight problems washing or dressing | 200 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Moderate problems washing or dressing | 102 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Severe problems washing or dressing | 9 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Unable to wash or dress | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | No problems washing or dressing | 359 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Slight problems washing or dressing | 136 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Moderate problems washing or dressing | 54 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Severe problems washing or dressing | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Unable to wash or dress | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | No problems washing or dressing | 294 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Slight problems washing or dressing | 115 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Moderate problems washing or dressing | 47 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Severe problems washing or dressing | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Unable to wash or dress | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Slight problems washing or dressing | 136 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Moderate problems washing or dressing | 89 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Severe problems washing or dressing | 11 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Unable to wash or dress | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Severe problems washing or dressing | 2 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Severe problems washing or dressing | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Slight problems washing or dressing | 246 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Slight problems washing or dressing | 131 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Unable to wash or dress | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | No problems washing or dressing | 583 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Moderate problems washing or dressing | 350 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | No problems washing or dressing | 291 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Unable to wash or dress | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | No problems washing or dressing | 270 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Slight problems washing or dressing | 122 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Severe problems washing or dressing | 3 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Moderate problems washing or dressing | 57 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Moderate problems washing or dressing | 40 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Moderate problems washing or dressing | 134 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Slight problems washing or dressing | 319 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Severe problems washing or dressing | 5 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | Slight problems washing or dressing | 276 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | Unable to wash or dress | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Moderate problems washing or dressing | 86 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 56 | Unable to wash or dress | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Severe problems washing or dressing | 8 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Slight problems washing or dressing | 192 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 8 | No problems washing or dressing | 542 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | Unable to wash or dress | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 24 | No problems washing or dressing | 527 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Unable to wash or dress | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | No problems washing or dressing | 371 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Unable to wash or dress | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 64 | No problems washing or dressing | 264 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Slight problems washing or dressing | 125 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Severe problems washing or dressing | 9 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Baseline | Severe problems washing or dressing | 55 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 40 | Moderate problems washing or dressing | 38 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | Week 16 | Moderate problems washing or dressing | 77 Participants |
Secondary
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain
Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the 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, Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Unable to do usual activities | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Moderate problems doing usual activities | 184 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Severe problems doing usual activities | 37 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Severe problems doing usual activities | 12 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Severe problems doing usual activities | 24 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | No problems doing usual activities | 22 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Moderate problems doing usual activities | 85 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Unable to do usual activities | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | No problems doing usual activities | 229 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Slight problems doing usual activities | 239 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | No problems doing usual activities | 262 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Moderate problems doing usual activities | 538 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | No problems doing usual activities | 225 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Slight problems doing usual activities | 353 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | No problems doing usual activities | 101 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Unable to do usual activities | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Moderate problems doing usual activities | 174 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Slight problems doing usual activities | 402 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Severe problems doing usual activities | 27 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Slight problems doing usual activities | 229 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Unable to do usual activities | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Moderate problems doing usual activities | 292 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Moderate problems doing usual activities | 138 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Severe problems doing usual activities | 13 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Severe problems doing usual activities | 33 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Severe problems doing usual activities | 208 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Moderate problems doing usual activities | 79 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Unable to do usual activities | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Unable to do usual activities | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Slight problems doing usual activities | 211 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | No problems doing usual activities | 302 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Slight problems doing usual activities | 173 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | No problems doing usual activities | 155 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Slight problems doing usual activities | 402 Participants |
| Tanezumab 2.5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Unable to do usual activities | 3 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | No problems doing usual activities | 69 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | No problems doing usual activities | 24 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Slight problems doing usual activities | 218 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Moderate problems doing usual activities | 551 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Severe problems doing usual activities | 201 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Unable to do usual activities | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | No problems doing usual activities | 266 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Slight problems doing usual activities | 411 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Moderate problems doing usual activities | 256 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Severe problems doing usual activities | 31 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Unable to do usual activities | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | No problems doing usual activities | 333 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Slight problems doing usual activities | 382 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Moderate problems doing usual activities | 182 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Severe problems doing usual activities | 21 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Unable to do usual activities | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | No problems doing usual activities | 290 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Slight problems doing usual activities | 315 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Moderate problems doing usual activities | 182 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Severe problems doing usual activities | 27 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Unable to do usual activities | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | No problems doing usual activities | 221 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Slight problems doing usual activities | 213 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Moderate problems doing usual activities | 97 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Severe problems doing usual activities | 20 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Unable to do usual activities | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | No problems doing usual activities | 170 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Slight problems doing usual activities | 179 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Moderate problems doing usual activities | 86 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Severe problems doing usual activities | 22 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Unable to do usual activities | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Slight problems doing usual activities | 163 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Moderate problems doing usual activities | 155 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Severe problems doing usual activities | 37 Participants |
| Tanezumab 5 mg | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Unable to do usual activities | 4 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Severe problems doing usual activities | 12 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Severe problems doing usual activities | 10 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Slight problems doing usual activities | 408 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Slight problems doing usual activities | 197 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Unable to do usual activities | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | No problems doing usual activities | 310 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Moderate problems doing usual activities | 561 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | No problems doing usual activities | 182 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Unable to do usual activities | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | No problems doing usual activities | 38 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Slight problems doing usual activities | 199 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Severe problems doing usual activities | 35 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Moderate problems doing usual activities | 115 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Moderate problems doing usual activities | 69 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Moderate problems doing usual activities | 274 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Slight problems doing usual activities | 225 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Severe problems doing usual activities | 9 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | Slight problems doing usual activities | 426 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | Unable to do usual activities | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Moderate problems doing usual activities | 166 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 56 | Unable to do usual activities | 0 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Severe problems doing usual activities | 29 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Slight problems doing usual activities | 344 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 8 | No problems doing usual activities | 221 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | Unable to do usual activities | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 24 | No problems doing usual activities | 273 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Unable to do usual activities | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | No problems doing usual activities | 218 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Unable to do usual activities | 1 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 64 | No problems doing usual activities | 129 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Slight problems doing usual activities | 233 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Severe problems doing usual activities | 24 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Baseline | Severe problems doing usual activities | 169 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 40 | Moderate problems doing usual activities | 74 Participants |
| NSAID | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | Week 16 | Moderate problems doing usual activities | 172 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 pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 681 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 78 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 744 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 110 Participants |
| NSAID | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 666 Participants |
| NSAID | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 66 Participants |
Secondary
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a 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 Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment Related AEs | 190 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment Related SAEs | 7 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment Related AEs | 250 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment Related SAEs | 20 Participants |
| NSAID | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment Related AEs | 179 Participants |
| NSAID | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment Related SAEs | 7 Participants |
Secondary
Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tanezumab 2.5 mg | Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome | 9.7 events per 1000 participant-years |
| Tanezumab 5 mg | Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome | 21.8 events per 1000 participant-years |
| NSAID | Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome | 4.9 events per 1000 participant-years |
p-value: 0.203595% CI: [-2.6, 12.2]Poisson model for rate difference
p-value: 0.00195% CI: [6.8, 27]Poisson model for rate difference
Secondary
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 1 or 2 | 31.4 events per 1000 participant-years |
| Tanezumab 2.5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 1 | 28.4 events per 1000 participant-years |
| Tanezumab 2.5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 2 | 2.9 events per 1000 participant-years |
| Tanezumab 2.5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Primary Osteonecrosis | 1.0 events per 1000 participant-years |
| Tanezumab 2.5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Pathological Fracture | 0 events per 1000 participant-years |
| Tanezumab 2.5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Subchondral Insufficiency Fracture | 5.8 events per 1000 participant-years |
| Tanezumab 5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Subchondral Insufficiency Fracture | 6.9 events per 1000 participant-years |
| Tanezumab 5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 1 or 2 | 63.3 events per 1000 participant-years |
| Tanezumab 5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Primary Osteonecrosis | 1.0 events per 1000 participant-years |
| Tanezumab 5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Pathological Fracture | 0 events per 1000 participant-years |
| Tanezumab 5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 1 | 49.1 events per 1000 participant-years |
| Tanezumab 5 mg | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 2 | 13.9 events per 1000 participant-years |
| NSAID | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 1 | 10.9 events per 1000 participant-years |
| NSAID | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 2 | 1.0 events per 1000 participant-years |
| NSAID | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Subchondral Insufficiency Fracture | 3.9 events per 1000 participant-years |
| NSAID | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Primary Osteonecrosis | 0 events per 1000 participant-years |
| NSAID | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 1 or 2 | 11.9 events per 1000 participant-years |
| NSAID | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | Pathological Fracture | 0 events per 1000 participant-years |
Comparison: Rapidly Progressive OA Type 1 or 2p-value: 0.002795% CI: [6.78, 32.35]Poisson model for rate difference
Comparison: Rapidly Progressive OA Type 1 or 2p-value: <0.000195% CI: [34.47, 68.5]Poisson model for rate difference
Comparison: Rapidly Progressive OA Type 1p-value: 0.004795% CI: [5.39, 29.76]Poisson model for rate difference
Comparison: Rapidly Progressive OA Type 1p-value: <0.000195% CI: [23.05, 53.4]Poisson model for rate difference
Comparison: Rapidly Progressive OA Type 2p-value: 0.321495% CI: [-1.89, 5.76]Poisson model for rate difference
Comparison: Rapidly Progressive OA Type 2p-value: 0.000895% CI: [5.36, 20.39]Poisson model for rate difference
Comparison: Subchondral Insufficiency Fracturep-value: 0.539495% CI: [-4.17, 7.96]Poisson model for rate difference
Comparison: Subchondral Insufficiency Fracturep-value: 0.363695% CI: [-3.44, 9.39]Poisson model for rate difference
Comparison: Primary osteonecrosis
Comparison: Primary osteonecrosis
Secondary
Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tanezumab 2.5 mg | Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | 84.9 events per 1000 participant-years |
| Tanezumab 5 mg | Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | 132.5 events per 1000 participant-years |
| NSAID | Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | 36.7 events per 1000 participant-years |
p-value: <0.000195% CI: [26.76, 69.74]Poisson model for rate difference
p-value: <0.000195% CI: [70.25, 121.42]Poisson model for rate difference
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?
The mPRTI is a self-administered questionnaire containing 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 preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the 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 the investigational product. Number of participants who responded for the specified question were reported.
Time frame: Weeks 16 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, Number analyzed = participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 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 | 577 Participants |
| Tanezumab 2.5 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 | 141 Participants |
| Tanezumab 2.5 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 | 149 Participants |
| Tanezumab 2.5 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 | 28 Participants |
| Tanezumab 2.5 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 | 44 Participants |
| Tanezumab 2.5 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 | 342 Participants |
| Tanezumab 2.5 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 | 70 Participants |
| Tanezumab 2.5 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 | 61 Participants |
| Tanezumab 2.5 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 | 16 Participants |
| Tanezumab 2.5 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 | 9 Participants |
| 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 | 16 Participants |
| 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 | 597 Participants |
| 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 | 323 Participants |
| 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 | 40 Participants |
| 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 | 169 Participants |
| 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 | 8 Participants |
| 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 | 65 Participants |
| 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 | 114 Participants |
| 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 | 75 Participants |
| 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 | 34 Participants |
| NSAID | 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 | 71 Participants |
| NSAID | 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 | 36 Participants |
| NSAID | 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 | 47 Participants |
| NSAID | 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 | 302 Participants |
| NSAID | 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 | 13 Participants |
| NSAID | 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 | 89 Participants |
| NSAID | 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 | 531 Participants |
| NSAID | 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 | 14 Participants |
| NSAID | 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 | 158 Participants |
| NSAID | 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 | 164 Participants |
Comparison: Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.0823Cochran-Mantel-Haenszel
Comparison: Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.0049Cochran-Mantel-Haenszel
Comparison: Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.0718Cochran-Mantel-Haenszel
Comparison: Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.1947Cochran-Mantel-Haenszel
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 Osteoarthritis Pain Before Enrolling?
The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent 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. Number of participants who responded for the specified question were reported.
Time frame: Weeks 16 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, Number analyzed signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Injectable prescription medicines | 99 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines taken by mouth | 611 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Surgery | 7 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines and surgery | 33 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 16 | No treatment | 189 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Injectable prescription medicines | 44 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Prescription medicines taken by mouth | 307 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Surgery | 8 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Prescription medicines and surgery | 20 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain Before Enrolling? | Week 56 | No treatment | 119 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Prescription medicines and surgery | 18 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Injectable prescription medicines | 98 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Injectable prescription medicines | 47 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 16 | No treatment | 188 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines taken by mouth | 633 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 56 | No treatment | 122 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Surgery | 4 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Surgery | 7 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Prescription medicines taken by mouth | 296 Participants |
| 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines and surgery | 28 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Surgery | 2 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines and surgery | 27 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 16 | No treatment | 171 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Injectable prescription medicines | 40 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Prescription medicines and surgery | 20 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 56 | Prescription medicines taken by mouth | 324 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Injectable prescription medicines | 82 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 56 | No treatment | 103 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines taken by mouth | 647 Participants |
| NSAID | 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 Osteoarthritis Pain Before Enrolling? | Week 16 | Surgery | 9 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 Osteoarthritis Pain?
The mPRTI is a self-administered questionnaire containing 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 participant willingness to use drug again, participants responded using IRT on a 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. Number of participants who responded for the specified question were reported.
Time frame: Weeks 16 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, Number analyzed = participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 16 | Yes, definitely want to use the same drug again | 627 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 16 | Might want to use the same drug again | 138 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 16 | I am not sure | 108 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 16 | Might not want to use the same drug again | 19 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 16 | No:definitely wouldn't want to use same drug again | 47 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 56 | Yes, definitely want to use the same drug again | 352 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 56 | Might want to use the same drug again | 78 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 56 | I am not sure | 54 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 56 | Might not want to use the same drug again | 4 Participants |
| Tanezumab 2.5 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 Osteoarthritis Pain? | Week 56 | No:definitely wouldn't want to use same drug again | 10 Participants |
| 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 Osteoarthritis Pain? | Week 56 | Might not want to use the same drug again | 11 Participants |
| 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 Osteoarthritis Pain? | Week 16 | Yes, definitely want to use the same drug again | 641 Participants |
| 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 Osteoarthritis Pain? | Week 56 | Yes, definitely want to use the same drug again | 341 Participants |
| 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 Osteoarthritis Pain? | Week 16 | No:definitely wouldn't want to use same drug again | 42 Participants |
| 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 Osteoarthritis Pain? | Week 16 | Might want to use the same drug again | 154 Participants |
| 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 Osteoarthritis Pain? | Week 56 | No:definitely wouldn't want to use same drug again | 14 Participants |
| 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 Osteoarthritis Pain? | Week 56 | I am not sure | 46 Participants |
| 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 Osteoarthritis Pain? | Week 16 | I am not sure | 96 Participants |
| 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 Osteoarthritis Pain? | Week 56 | Might want to use the same drug again | 75 Participants |
| 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 Osteoarthritis Pain? | Week 16 | Might not want to use the same drug again | 21 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 56 | I am not sure | 58 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 16 | Might not want to use the same drug again | 23 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 16 | No:definitely wouldn't want to use same drug again | 50 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 56 | Yes, definitely want to use the same drug again | 310 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 56 | Might not want to use the same drug again | 12 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 56 | Might want to use the same drug again | 97 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 16 | Yes, definitely want to use the same drug again | 560 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 56 | No:definitely wouldn't want to use same drug again | 12 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 16 | Might want to use the same drug again | 169 Participants |
| NSAID | 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 Osteoarthritis Pain? | Week 16 | I am not sure | 134 Participants |
Comparison: Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.0229Cochran-Mantel-Haenszel
Comparison: Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.0029Cochran-Mantel-Haenszel
Comparison: Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.0266Cochran-Mantel-Haenszel
Comparison: Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)p-value: 0.1835Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Overall number of participants analyzed = participants who were evaluable for this outcome measure. Number analyzed=participants who were evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40 | 21.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8 | 21.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48 | 22.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56 | 21.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2 | 14.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64 | 21.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16 | 29.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4 | 21.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24 | 23.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32 | 23.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40 | 21.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16 | 30.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32 | 22.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48 | 21.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8 | 23.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2 | 15.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56 | 19.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24 | 24.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4 | 22.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64 | 17.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24 | 23.7 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2 | 11.6 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4 | 15.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8 | 19.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16 | 28.2 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64 | 25.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32 | 23.6 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40 | 21.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48 | 21.1 percentage of participants |
| NSAID | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56 | 20.8 percentage of participants |
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.000295% CI: [1.26, 2.1]Regression, Logistic
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.177295% CI: [0.91, 1.62]Regression, Logistic
Comparison: Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.015495% CI: [1.07, 1.89]Regression, Logistic
Comparison: Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.010595% CI: [1.08, 1.81]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.400795% CI: [0.87, 1.43]Regression, Logistic
Comparison: Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.011695% CI: [1.07, 1.75]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.627995% CI: [0.76, 1.18]Regression, Logistic
Comparison: Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.467495% CI: [0.87, 1.35]Regression, Logistic
Comparison: Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.313595% CI: [0.71, 1.12]Regression, Logistic
Comparison: Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.758195% CI: [0.83, 1.3]Regression, Logistic
Comparison: Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.450495% CI: [0.73, 1.15]Regression, Logistic
Comparison: Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.262995% CI: [0.7, 1.1]Regression, Logistic
Comparison: Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.676395% CI: [0.75, 1.2]Regression, Logistic
Comparison: Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.945695% CI: [0.8, 1.27]Regression, Logistic
Comparison: Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.75295% CI: [0.76, 1.22]Regression, Logistic
Comparison: Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.998195% CI: [0.79, 1.26]Regression, Logistic
Comparison: Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.528495% CI: [0.74, 1.17]Regression, Logistic
Comparison: Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.p-value: 0.32295% CI: [0.7, 1.12]Regression, Logistic
Secondary
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Percentage of participants with reduction in WOMAC pain intensity of \>= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Number analyzed=participants who were evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 70% reduction | 19.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 50% reduction | 17.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 70% reduction | 7.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 90% reduction | 2.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 30% reduction | 50.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 50% reduction | 30.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 70% reduction | 14.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 90% reduction | 4.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 30% reduction | 55.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 50% reduction | 36.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 30% reduction | 34.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 90% reduction | 4.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 30% reduction | 71.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 50% reduction | 54.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 70% reduction | 28.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 90% reduction | 10.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 30% reduction | 59.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 50% reduction | 49.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 70% reduction | 30.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 90% reduction | 10.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 30% reduction | 56.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 50% reduction | 47.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 70% reduction | 31.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 90% reduction | 10.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 30% reduction | 55.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 50% reduction | 47.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 70% reduction | 30.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 90% reduction | 10.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 30% reduction | 54.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 50% reduction | 46.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 70% reduction | 29.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 90% reduction | 10.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 30% reduction | 53.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 50% reduction | 44.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 70% reduction | 28.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 90% reduction | 10.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 30% reduction | 73.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 50% reduction | 55.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 70% reduction | 31.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 90% reduction | 9.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 50% reduction | 56.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 90% reduction | 11.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 70% reduction | 35.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 90% reduction | 12.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 50% reduction | 47.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 30% reduction | 61.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 30% reduction | 51.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 50% reduction | 49.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 70% reduction | 33.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 90% reduction | 13.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 50% reduction | 41.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 30% reduction | 55.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 50% reduction | 45.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 90% reduction | 7.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 70% reduction | 31.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 70% reduction | 27.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 90% reduction | 12.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 30% reduction | 54.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 70% reduction | 24.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 50% reduction | 45.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 90% reduction | 10.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 70% reduction | 30.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 30% reduction | 30.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 50% reduction | 16.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 90% reduction | 12.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 70% reduction | 7.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 90% reduction | 2.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 30% reduction | 49.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 30% reduction | 52.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 50% reduction | 30.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 70% reduction | 16.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 30% reduction | 69.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 90% reduction | 4.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 50% reduction | 43.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 30% reduction | 59.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 50% reduction | 39.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 70% reduction | 22.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 70% reduction | 29.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 90% reduction | 6.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 30% reduction | 72.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 70% reduction | 29.3 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 50% reduction | 51.5 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 70% reduction | 15.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 30% reduction | 32.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 70% reduction | 28.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 90% reduction | 10.6 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 90% reduction | 10.1 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 90% reduction | 8.5 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 90% reduction | 3.1 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 50% reduction | 14.7 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 30% reduction | 59.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 90% reduction | 12.6 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 30% reduction | 68.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 50% reduction | 47.5 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 30% reduction | 52.7 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 70% reduction | 6.2 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 70% reduction | 29.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 50% reduction | 60.2 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 90% reduction | 10.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 90% reduction | 11.5 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 30% reduction | 54.1 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 90% reduction | 1.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 30% reduction | 56.3 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 50% reduction | 43.5 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 70% reduction | 34.2 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 50% reduction | 46.3 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 50% reduction | 44.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 30% reduction | 44.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 70% reduction | 27.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 90% reduction | 4.2 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 50% reduction | 32.6 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 90% reduction | 10.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 70% reduction | 27.5 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 50% reduction | 24.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 30% reduction | 54.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 30% reduction | 54.2 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 30% reduction | 81.3 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 50% reduction | 46.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 70% reduction | 11.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 70% reduction | 28.5 percentage of participants |
Comparison: Week 2: \>=30% reductionp-value: 0.293895% CI: [0.92, 1.33]Regression, Logistic
Comparison: Week 2: \>=30% reductionp-value: 0.314695% CI: [0.75, 1.1]Regression, Logistic
Comparison: Week 2: \>=50% reductionp-value: 0.074895% CI: [0.98, 1.58]Regression, Logistic
Comparison: Week 2: \>=50% reductionp-value: 0.395% CI: [0.89, 1.45]Regression, Logistic
Comparison: Week 2: \>=70% reductionp-value: 0.25595% CI: [0.86, 1.74]Regression, Logistic
Comparison: Week 2: \>=70% reductionp-value: 0.47895% CI: [0.8, 1.62]Regression, Logistic
Comparison: Week 2: \>=90% reductionp-value: 0.400695% CI: [0.7, 2.42]Regression, Logistic
Comparison: Week 2: \>=90% reductionp-value: 0.308995% CI: [0.74, 2.54]Regression, Logistic
Comparison: Week 4: \>=30% reductionp-value: 0.011495% CI: [1.05, 1.5]Regression, Logistic
Comparison: Week 4: \>=30% reductionp-value: 0.023995% CI: [1.03, 1.47]Regression, Logistic
Comparison: Week 4: \>=50% reductionp-value: 0.007995% CI: [1.07, 1.6]Regression, Logistic
Comparison: Week 4: \>=50% reductionp-value: 0.006895% CI: [1.08, 1.6]Regression, Logistic
Comparison: Week 4: \>=70% reductionp-value: 0.103795% CI: [0.96, 1.62]Regression, Logistic
Comparison: Week 4: \>=70% reductionp-value: 0.004695% CI: [1.12, 1.88]Regression, Logistic
Comparison: Week 4: \>=90% reductionp-value: 0.197195% CI: [0.85, 2.19]Regression, Logistic
Comparison: Week 4: \>=90% reductionp-value: 0.04895% CI: [1, 2.52]Regression, Logistic
Comparison: Week 8: \>=30% reductionp-value: 0.474495% CI: [0.89, 1.28]Regression, Logistic
Comparison: Week 8: \>=30% reductionp-value: 0.033695% CI: [1.02, 1.45]Regression, Logistic
Comparison: Week 8: \>=50% reductionp-value: 0.055995% CI: [1, 1.44]Regression, Logistic
Comparison: Week 8: \>=50% reductionp-value: 0.002195% CI: [1.11, 1.61]Regression, Logistic
Comparison: Week 8: \>=70% reductionp-value: 0.053595% CI: [1, 1.59]Regression, Logistic
Comparison: Week 8: \>=70% reductionp-value: 0.000395% CI: [1.22, 1.92]Regression, Logistic
Comparison: Week 8: \>=90% reductionp-value: 0.642195% CI: [0.72, 1.7]Regression, Logistic
Comparison: Week 8: \>=90% reductionp-value: 0.020795% CI: [1.07, 2.38]Regression, Logistic
Comparison: Week 16: \>=30% reductionp-value: 0.163595% CI: [0.95, 1.39]Regression, Logistic
Comparison: Week 16: \>=30% reductionp-value: 0.052995% CI: [1, 1.47]Regression, Logistic
Comparison: Week 16: \>=50% reductionp-value: 0.132295% CI: [0.96, 1.37]Regression, Logistic
Comparison: Week 16: \>=50% reductionp-value: 0.026295% CI: [1.02, 1.46]Regression, Logistic
Comparison: Week 16: \>=70% reductionp-value: 0.980595% CI: [0.83, 1.22]Regression, Logistic
Comparison: Week 16: \>=70% reductionp-value: 0.003395% CI: [1.1, 1.61]Regression, Logistic
Comparison: Week 16: \>=90% reductionp-value: 0.15995% CI: [0.92, 1.69]Regression, Logistic
Comparison: Week 16: \>=90% reductionp-value: 0.002495% CI: [1.17, 2.11]Regression, Logistic
Comparison: Week 24: \>=30% reductionp-value: 0.993295% CI: [0.83, 1.2]Regression, Logistic
Comparison: Week 24: \>=30% reductionp-value: 0.437495% CI: [0.9, 1.29]Regression, Logistic
Comparison: Week 24: \>=50% reductionp-value: 0.440695% CI: [0.9, 1.28]Regression, Logistic
Comparison: Week 24: \>=50% reductionp-value: 0.407895% CI: [0.9, 1.29]Regression, Logistic
Comparison: Week 24: \>=70% reductionp-value: 0.407195% CI: [0.89, 1.31]Regression, Logistic
Comparison: Week 24: \>=70% reductionp-value: 0.024895% CI: [1.03, 1.5]Regression, Logistic
Comparison: Week 24: \>=90% reductionp-value: 0.364195% CI: [0.66, 1.16]Regression, Logistic
Comparison: Week 24: \>=90% reductionp-value: 0.249795% CI: [0.89, 1.53]Regression, Logistic
Comparison: Week 32: \>=30% reductionp-value: 0.868295% CI: [0.85, 1.21]Regression, Logistic
Comparison: Week 32: \>=30% reductionp-value: 0.731795% CI: [0.81, 1.16]Regression, Logistic
Comparison: Week 32: \>=50% reductionp-value: 0.649395% CI: [0.87, 1.24]Regression, Logistic
Comparison: Week 32: \>=50% reductionp-value: 0.797395% CI: [0.82, 1.17]Regression, Logistic
Comparison: Week 32: \>=70% reductionp-value: 0.075795% CI: [0.98, 1.45]Regression, Logistic
Comparison: Week 32: \>=70% reductionp-value: 0.057895% CI: [0.99, 1.47]Regression, Logistic
Comparison: Week 32: \>=90% reductionp-value: 0.90195% CI: [0.76, 1.37]Regression, Logistic
Comparison: Week 32: \>=90% reductionp-value: 0.054895% CI: [0.99, 1.74]Regression, Logistic
Comparison: Week 40: \>=30% reductionp-value: 0.733195% CI: [0.86, 1.23]Regression, Logistic
Comparison: Week 40: \>=30% reductionp-value: 0.863295% CI: [0.82, 1.18]Regression, Logistic
Comparison: Week 40: \>=50% reductionp-value: 0.626295% CI: [0.88, 1.25]Regression, Logistic
Comparison: Week 40: \>=50% reductionp-value: 0.681795% CI: [0.81, 1.15]Regression, Logistic
Comparison: Week 40: \>=70% reductionp-value: 0.79995% CI: [0.85, 1.24]Regression, Logistic
Comparison: Week 40: \>=70% reductionp-value: 0.678695% CI: [0.86, 1.26]Regression, Logistic
Comparison: Week 40: \>=90% reductionp-value: 0.806995% CI: [0.78, 1.38]Regression, Logistic
Comparison: Week 40: \>=90% reductionp-value: 0.295195% CI: [0.88, 1.54]Regression, Logistic
Comparison: Week 48: \>=30% reductionp-value: 0.909395% CI: [0.85, 1.21]Regression, Logistic
Comparison: Week 48: \>=30% reductionp-value: 0.503295% CI: [0.79, 1.12]Regression, Logistic
Comparison: Week 48: \>=50% reductionp-value: 0.438295% CI: [0.9, 1.28]Regression, Logistic
Comparison: Week 48: \>=50% reductionp-value: 0.563895% CI: [0.79, 1.13]Regression, Logistic
Comparison: Week 48: \>=70% reductionp-value: 0.643695% CI: [0.86, 1.27]Regression, Logistic
Comparison: Week 48: \>=70% reductionp-value: 0.70695% CI: [0.85, 1.26]Regression, Logistic
Comparison: Week 48: \>=90% reductionp-value: 0.772995% CI: [0.72, 1.28]Regression, Logistic
Comparison: Week 48: \>=90% reductionp-value: 0.640595% CI: [0.81, 1.42]Regression, Logistic
Comparison: Week 56: \>=30% reductionp-value: 0.904695% CI: [0.85, 1.21]Regression, Logistic
Comparison: Week 56: \>=30% reductionp-value: 0.449195% CI: [0.78, 1.11]Regression, Logistic
Comparison: Week 56: \>=50% reductionp-value: 0.742995% CI: [0.86, 1.23]Regression, Logistic
Comparison: Week 56: \>=50% reductionp-value: 0.346795% CI: [0.77, 1.1]Regression, Logistic
Comparison: Week 56: \>=70% reductionp-value: 0.762495% CI: [0.85, 1.26]Regression, Logistic
Comparison: Week 56: \>=70% reductionp-value: 0.768695% CI: [0.8, 1.18]Regression, Logistic
Comparison: Week 56: \>=90% reductionp-value: 0.938495% CI: [0.74, 1.33]Regression, Logistic
Comparison: Week 56: \>=90% reductionp-value: 0.849595% CI: [0.77, 1.38]Regression, Logistic
Secondary
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Percentage of participants with reduction in WOMAC physical function of \>=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Overall number of participants analyzed = participants who were evaluable for this outcome measure. Number analyzed=participants who were evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 70% reduction | 18.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 50% reduction | 20.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 70% reduction | 8.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 90% reduction | 2.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 30% reduction | 49.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 50% reduction | 31.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 70% reduction | 15.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 90% reduction | 4.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 30% reduction | 56.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 50% reduction | 36.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 30% reduction | 35.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 90% reduction | 5.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 30% reduction | 71.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 50% reduction | 53.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 70% reduction | 29.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 90% reduction | 10.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 30% reduction | 59.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 50% reduction | 49.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 70% reduction | 30.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 90% reduction | 11.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 30% reduction | 56.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 50% reduction | 47.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 70% reduction | 29.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 90% reduction | 11.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 30% reduction | 55.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 50% reduction | 45.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 70% reduction | 29.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 90% reduction | 10.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 30% reduction | 54.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 50% reduction | 45.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 70% reduction | 29.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 90% reduction | 10.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 30% reduction | 52.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 50% reduction | 44.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 70% reduction | 26.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 90% reduction | 9.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 30% reduction | 71.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 50% reduction | 52.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 70% reduction | 31.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 90% reduction | 9.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 50% reduction | 55.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 90% reduction | 12.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 70% reduction | 34.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 90% reduction | 13.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 50% reduction | 44.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 30% reduction | 61.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 30% reduction | 51.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 50% reduction | 48.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 70% reduction | 32.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 90% reduction | 13.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 50% reduction | 41.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 30% reduction | 56.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 50% reduction | 45.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 90% reduction | 7.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 70% reduction | 30.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 70% reduction | 26.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 90% reduction | 13.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 30% reduction | 55.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 70% reduction | 22.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 50% reduction | 45.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 90% reduction | 10.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 70% reduction | 29.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 30% reduction | 32.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 50% reduction | 17.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 90% reduction | 13.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 70% reduction | 8.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 90% reduction | 3.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 30% reduction | 49.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 30% reduction | 53.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 50% reduction | 31.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 70% reduction | 15.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 30% reduction | 68.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 90% reduction | 5.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 50% reduction | 43.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 30% reduction | 59.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 50% reduction | 40.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 70% reduction | 21.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 70% reduction | 27.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 90% reduction | 7.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 30% reduction | 71.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 70% reduction | 27.6 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 50% reduction | 50.1 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 70% reduction | 14.1 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 30% reduction | 31.7 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 70% reduction | 27.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 90% reduction | 9.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 90% reduction | 9.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 90% reduction | 9.7 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 90% reduction | 2.6 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 50% reduction | 15.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 30% reduction | 59.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 90% reduction | 13.3 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16: At least 30% reduction | 68.1 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 50% reduction | 46.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 30% reduction | 52.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 70% reduction | 5.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 70% reduction | 27.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 50% reduction | 58.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 90% reduction | 9.5 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24: At least 90% reduction | 9.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 30% reduction | 55.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2: At least 90% reduction | 1.7 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 30% reduction | 55.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 50% reduction | 42.5 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 70% reduction | 33.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 50% reduction | 44.7 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 50% reduction | 43.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 30% reduction | 43.2 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 70% reduction | 26.8 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 90% reduction | 4.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8: At least 50% reduction | 31.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32: At least 90% reduction | 9.4 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56: At least 70% reduction | 26.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 50% reduction | 23.1 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 30% reduction | 54.9 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 30% reduction | 54.6 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64: At least 30% reduction | 78.2 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40: At least 50% reduction | 45.0 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4: At least 70% reduction | 11.2 percentage of participants |
| NSAID | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48: At least 70% reduction | 26.1 percentage of participants |
Comparison: Week 4: \>=70% reductionp-value: 0.003195% CI: [1.14, 1.93]Regression, Logistic
Comparison: Week 4: \>=90% reductionp-value: 0.023595% CI: [1.08, 2.88]Regression, Logistic
Comparison: Week 4: \>=90% reductionp-value: 0.002195% CI: [1.31, 3.42]Regression, Logistic
Comparison: Week 8: \>=30% reductionp-value: 0.761395% CI: [0.86, 1.23]Regression, Logistic
Comparison: Week 8: \>=30% reductionp-value: 0.054895% CI: [1, 1.43]Regression, Logistic
Comparison: Week 8: \>=50% reductionp-value: 0.019695% CI: [1.04, 1.51]Regression, Logistic
Comparison: Week 8: \>=50% reductionp-value: <0.000195% CI: [1.2, 1.75]Regression, Logistic
Comparison: Week 8: \>=70% reductionp-value: 0.007795% CI: [1.09, 1.77]Regression, Logistic
Comparison: Week 8: \>=70% reductionp-value: <0.000195% CI: [1.3, 2.09]Regression, Logistic
Comparison: Week 8: \>=90% reductionp-value: 0.194295% CI: [0.87, 1.96]Regression, Logistic
Comparison: Week 8: \>=90% reductionp-value: 0.012295% CI: [1.11, 2.43]Regression, Logistic
Comparison: Week 16: \>=30% reductionp-value: 0.097795% CI: [0.97, 1.43]Regression, Logistic
Comparison: Week 16: \>=30% reductionp-value: 0.080695% CI: [0.98, 1.44]Regression, Logistic
Comparison: Week 2: \>=30% reductionp-value: 0.065195% CI: [0.99, 1.44]Regression, Logistic
Comparison: Week 2: \>=30% reductionp-value: 0.903295% CI: [0.84, 1.22]Regression, Logistic
Comparison: Week 2: \>=50% reductionp-value: 0.0195% CI: [1.08, 1.72]Regression, Logistic
Comparison: Week 2: \>=50% reductionp-value: 0.372895% CI: [0.88, 1.42]Regression, Logistic
Comparison: Week 2: \>=70% reductionp-value: 0.043495% CI: [1.01, 2.04]Regression, Logistic
Comparison: Week 2: \>=70% reductionp-value: 0.042595% CI: [1.01, 2.04]Regression, Logistic
Comparison: Week 2: \>=90% reductionp-value: 0.544295% CI: [0.64, 2.34]Regression, Logistic
Comparison: Week 2: \>=90% reductionp-value: 0.034995% CI: [1.05, 3.45]Regression, Logistic
Comparison: Week 4: \>=30% reductionp-value: 0.010895% CI: [1.05, 1.51]Regression, Logistic
Comparison: Week 4: \>=30% reductionp-value: 0.00895% CI: [1.07, 1.52]Regression, Logistic
Comparison: Week 4: \>=50% reductionp-value: <0.000195% CI: [1.22, 1.83]Regression, Logistic
Comparison: Week 4: \>=50% reductionp-value: <0.000195% CI: [1.24, 1.85]Regression, Logistic
Comparison: Week 4: \>=70% reductionp-value: 0.00695% CI: [1.11, 1.88]Regression, Logistic
Comparison: Week 16: \>=50% reductionp-value: 0.209795% CI: [0.94, 1.34]Regression, Logistic
Comparison: Week 16: \>=50% reductionp-value: 0.013595% CI: [1.05, 1.49]Regression, Logistic
Comparison: Week 16: \>=90% reductionp-value: 0.010895% CI: [1.09, 1.9]Regression, Logistic
Comparison: Week 24: \>=30% reductionp-value: 0.839395% CI: [0.85, 1.22]Regression, Logistic
Comparison: Week 16: \>=70% reductionp-value: 0.357195% CI: [0.9, 1.33]Regression, Logistic
Comparison: Week 16: \>=70% reductionp-value: 0.002595% CI: [1.11, 1.63]Regression, Logistic
Comparison: Week 24: \>=30% reductionp-value: 0.297795% CI: [0.92, 1.32]Regression, Logistic
Comparison: Week 24: \>=50% reductionp-value: 0.194495% CI: [0.94, 1.34]Regression, Logistic
Comparison: Week 16: \>=90% reductionp-value: 0.465895% CI: [0.83, 1.49]Regression, Logistic
Comparison: Week 24: \>=50% reductionp-value: 0.571495% CI: [0.88, 1.26]Regression, Logistic
Comparison: Week 24: \>=70% reductionp-value: 0.247295% CI: [0.92, 1.36]Regression, Logistic
Comparison: Week 24: \>=70% reductionp-value: 0.023595% CI: [1.03, 1.51]Regression, Logistic
Comparison: Week 24: \>=90% reductionp-value: 0.407495% CI: [0.85, 1.51]Regression, Logistic
Comparison: Week 24: \>=90% reductionp-value: 0.029695% CI: [1.03, 1.81]Regression, Logistic
Comparison: Week 32: \>=30% reductionp-value: 0.760795% CI: [0.86, 1.23]Regression, Logistic
Comparison: Week 32: \>=30% reductionp-value: 0.797995% CI: [0.86, 1.22]Regression, Logistic
Comparison: Week 32: \>=50% reductionp-value: 0.296495% CI: [0.92, 1.31]Regression, Logistic
Comparison: Week 32: \>=50% reductionp-value: 0.69595% CI: [0.87, 1.24]Regression, Logistic
Comparison: Week 32: \>=70% reductionp-value: 0.198595% CI: [0.93, 1.38]Regression, Logistic
Comparison: Week 32: \>=70% reductionp-value: 0.123995% CI: [0.96, 1.42]Regression, Logistic
Comparison: Week 32: \>=90% reductionp-value: 0.276295% CI: [0.88, 1.58]Regression, Logistic
Comparison: Week 32: \>=90% reductionp-value: 0.012195% CI: [1.08, 1.91]Regression, Logistic
Comparison: Week 40: \>=30% reductionp-value: 0.844395% CI: [0.85, 1.22]Regression, Logistic
Comparison: Week 40: \>=30% reductionp-value: 0.847295% CI: [0.85, 1.22]Regression, Logistic
Comparison: Week 40: \>=50% reductionp-value: 0.89895% CI: [0.85, 1.21]Regression, Logistic
Comparison: Week 40: \>=50% reductionp-value: 0.938595% CI: [0.83, 1.19]Regression, Logistic
Comparison: Week 40: \>=70% reductionp-value: 0.426195% CI: [0.89, 1.32]Regression, Logistic
Comparison: Week 40: \>=70% reductionp-value: 0.52595% CI: [0.88, 1.3]Regression, Logistic
Comparison: Week 40: \>=90% reductionp-value: 0.627395% CI: [0.8, 1.45]Regression, Logistic
Comparison: Week 40: \>=90% reductionp-value: 0.013295% CI: [1.08, 1.9]Regression, Logistic
Comparison: Week 48: \>=30% reductionp-value: 0.909595% CI: [0.83, 1.18]Regression, Logistic
Comparison: Week 48: \>=30% reductionp-value: 0.509895% CI: [0.79, 1.12]Regression, Logistic
Comparison: Week 48: \>=50% reductionp-value: 0.448895% CI: [0.9, 1.28]Regression, Logistic
Comparison: Week 48: \>=50% reductionp-value: 0.975795% CI: [0.83, 1.19]Regression, Logistic
Comparison: Week 48: \>=70% reductionp-value: 0.184395% CI: [0.94, 1.39]Regression, Logistic
Comparison: Week 48: \>=70% reductionp-value: 0.435695% CI: [0.89, 1.32]Regression, Logistic
Comparison: Week 48: \>=90% reductionp-value: 0.634295% CI: [0.8, 1.45]Regression, Logistic
Comparison: Week 48: \>=90% reductionp-value: 0.08195% CI: [0.97, 1.73]Regression, Logistic
Comparison: Week 56: \>=30% reductionp-value: 0.652795% CI: [0.8, 1.15]Regression, Logistic
Comparison: Week 56: \>=30% reductionp-value: 0.385795% CI: [0.77, 1.1]Regression, Logistic
Comparison: Week 56: \>=50% reductionp-value: 0.52895% CI: [0.89, 1.27]Regression, Logistic
Comparison: Week 56: \>=50% reductionp-value: 0.535595% CI: [0.79, 1.13]Regression, Logistic
Comparison: Week 56: \>=70% reductionp-value: 0.773295% CI: [0.84, 1.26]Regression, Logistic
Comparison: Week 56: \>=70% reductionp-value: 0.939795% CI: [0.82, 1.23]Regression, Logistic
Comparison: Week 56: \>=90% reductionp-value: 0.904495% CI: [0.75, 1.39]Regression, Logistic
Comparison: Week 56: \>=90% reductionp-value: 0.319395% CI: [0.86, 1.57]Regression, Logistic
Secondary
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was \>=50 percent and \>= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and PGA of OA (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).
Time frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Number analyzed=participants who were evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2 | 46.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4 | 62.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8 | 67.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16 | 78.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24 | 62.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32 | 59.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40 | 58.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48 | 57.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56 | 56.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64 | 79.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56 | 54.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2 | 43.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32 | 59.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24 | 64.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4 | 62.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64 | 75.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48 | 56.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8 | 70.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40 | 58.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16 | 78.3 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 48 | 57.3 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 16 | 75.1 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 24 | 61.3 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 32 | 58.6 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 56 | 56.0 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 40 | 58.2 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 2 | 44.8 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 64 | 86.5 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 4 | 56.4 percentage of participants |
| NSAID | Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | Week 8 | 64.4 percentage of participants |
Comparison: Week 2p-value: 0.469195% CI: [0.89, 1.28]Regression, Logistic
Comparison: Week 2p-value: 0.545195% CI: [0.79, 1.13]Regression, Logistic
Comparison: Week 4p-value: 0.005995% CI: [1.08, 1.54]Regression, Logistic
Comparison: Week 4p-value: 0.005795% CI: [1.08, 1.55]Regression, Logistic
Comparison: Week 8p-value: 0.158495% CI: [0.95, 1.38]Regression, Logistic
Comparison: Week 8p-value: 0.00695% CI: [1.08, 1.58]Regression, Logistic
Comparison: Week 16p-value: 0.111795% CI: [0.96, 1.46]Regression, Logistic
Comparison: Week 16p-value: 0.100495% CI: [0.97, 1.47]Regression, Logistic
Comparison: Week 24p-value: 0.625895% CI: [0.87, 1.25]Regression, Logistic
Comparison: Week 24p-value: 0.115495% CI: [0.96, 1.39]Regression, Logistic
Comparison: Week 32p-value: 0.801895% CI: [0.86, 1.22]Regression, Logistic
Comparison: Week 32p-value: 0.569795% CI: [0.88, 1.26]Regression, Logistic
Comparison: Week 40p-value: 0.955795% CI: [0.84, 1.2]Regression, Logistic
Comparison: Week 40p-value: 0.855395% CI: [0.85, 1.22]Regression, Logistic
Comparison: Week 48p-value: 0.990195% CI: [0.84, 1.2]Regression, Logistic
Comparison: Week 48p-value: 0.58795% CI: [0.8, 1.14]Regression, Logistic
Comparison: Week 56p-value: 0.830295% CI: [0.85, 1.22]Regression, Logistic
Comparison: Week 56p-value: 0.482395% CI: [0.79, 1.12]Regression, Logistic
Secondary
Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome
Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome | 1.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome | 2.2 percentage of participants |
| NSAID | Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome | 0.5 percentage of participants |
p-value: 0.408295% CI: [-0.75, 2.28]Exact methods for risk difference
p-value: 0.023895% CI: [0.31, 3.63]Exact methods for risk difference
Secondary
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than \[\>\] 0% ; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale 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.
Time frame: Baseline, Weeks 16, 24 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >0% | 66.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=40% | 63.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: =100% | 3.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=10% | 64.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=90% | 10.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >0% | 89.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=20% | 62.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=60% | 37.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=90% | 10.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=30% | 59.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=50% | 54.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=80% | 20.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=40% | 55.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=20% | 78.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=70% | 30.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=50% | 49.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=50% | 44.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=60% | 40.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=60% | 40.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=10% | 85.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=40% | 48.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=70% | 28.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=80% | 18.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=30% | 53.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=80% | 19.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=30% | 71.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=20% | 55.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=90% | 10.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: =100% | 4.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=10% | 59.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: =100% | 4.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=70% | 28.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >0% | 60.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=90% | 13.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >0% | 87.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=10% | 82.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=20% | 78.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=30% | 72.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=40% | 63.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=50% | 56.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=60% | 44.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=70% | 35.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=80% | 23.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=90% | 12.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: =100% | 3.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >0% | 68.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=10% | 66.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=20% | 65.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=30% | 61.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=40% | 55.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=50% | 49.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=60% | 41.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=70% | 33.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=80% | 24.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: =100% | 4.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >0% | 59.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=10% | 57.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=20% | 54.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=30% | 51.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=40% | 46.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=50% | 41.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=60% | 33.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=70% | 27.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=80% | 19.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=90% | 10.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: =100% | 5.3 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: =100% | 3.3 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=90% | 10.1 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >0% | 59.7 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=90% | 8.5 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=70% | 27.5 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=10% | 58.1 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=80% | 18.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=20% | 75.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=20% | 56.3 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=70% | 28.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >0% | 87.1 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=30% | 52.7 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=60% | 38.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=80% | 18.6 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=40% | 48.6 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=50% | 51.5 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=10% | 82.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=50% | 43.5 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=50% | 47.5 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=40% | 59.9 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=60% | 38.1 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=40% | 54.7 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: =100% | 4.1 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=70% | 29.0 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=30% | 59.4 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 56: >=60% | 36.3 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=80% | 20.2 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=20% | 62.1 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=10% | 63.4 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >=90% | 11.5 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: >0% | 64.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 16: >=30% | 68.9 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 | Week 24: =100% | 3.4 percentage of participants |
Secondary
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56
Percentage of participants with cumulative reduction (as percent) (\> 0 %; \>= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Baseline, Weeks 16, 24 and 56
Population: ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >0% | 66.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=40% | 63.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: =100% | 3.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=10% | 65.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=90% | 9.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >0% | 90.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=20% | 62.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=60% | 36.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=90% | 11.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=30% | 59.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=50% | 53.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=80% | 19.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=40% | 54.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=20% | 78.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=70% | 30.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=50% | 49.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=50% | 44.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=60% | 41.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=60% | 41.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=10% | 85.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=40% | 48.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=70% | 29.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=80% | 17.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=30% | 52.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=80% | 20.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=30% | 71.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=20% | 56.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=90% | 10.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: =100% | 2.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=10% | 59.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: =100% | 2.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=70% | 26.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >0% | 61.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=90% | 13.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >0% | 88.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=10% | 83.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=20% | 77.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=30% | 71.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=40% | 64.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=50% | 55.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=60% | 44.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=70% | 34.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=80% | 24.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=90% | 13.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: =100% | 3.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >0% | 68.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=10% | 66.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=20% | 64.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=30% | 61.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=40% | 56.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=50% | 48.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=60% | 42.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=70% | 32.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=80% | 22.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: =100% | 3.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >0% | 59.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=10% | 57.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=20% | 54.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=30% | 51.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=40% | 46.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=50% | 41.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=60% | 34.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=70% | 26.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=80% | 17.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=90% | 10.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: =100% | 3.6 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: =100% | 2.0 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=90% | 9.0 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >0% | 60.1 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=90% | 9.7 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=70% | 26.0 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=10% | 57.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=80% | 17.9 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=20% | 73.7 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=20% | 55.4 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=70% | 27.9 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >0% | 87.4 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=30% | 52.9 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=60% | 39.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=80% | 17.4 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=40% | 48.9 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=50% | 50.1 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=10% | 81.4 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=50% | 42.5 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=50% | 46.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=40% | 61.0 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=60% | 37.7 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=40% | 53.9 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: =100% | 3.3 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=70% | 27.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=30% | 59.0 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 56: >=60% | 34.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=80% | 18.9 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=20% | 60.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=10% | 63.3 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >=90% | 9.8 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: >0% | 65.0 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 16: >=30% | 68.1 percentage of participants |
| NSAID | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 | Week 24: =100% | 2.7 percentage of participants |
Secondary
Percentage of Participants With Individual Adjudicated Joint Safety Outcome
Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW \>=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 1 or 2 | 3.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA type 1 | 2.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA type 2 | 0.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Primary Osteonecrosis | 0.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Pathological Fracture | 0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Subchondral Insufficiency Fracture | 0.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Subchondral Insufficiency Fracture | 0.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 1 or 2 | 6.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Primary Osteonecrosis | 0.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Pathological Fracture | 0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA type 1 | 4.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA type 2 | 1.4 percentage of participants |
| NSAID | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA type 1 | 1.1 percentage of participants |
| NSAID | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA type 2 | 0.1 percentage of participants |
| NSAID | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Subchondral Insufficiency Fracture | 0.4 percentage of participants |
| NSAID | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Primary Osteonecrosis | 0 percentage of participants |
| NSAID | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Rapidly Progressive OA Type 1 or 2 | 1.2 percentage of participants |
| NSAID | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | Pathological Fracture | 0 percentage of participants |
Comparison: Rapidly progressive OA Type 1 or 2p-value: 0.024895% CI: [0.31, 4.17]Exact methods for risk difference
Comparison: Rapidly Progressive OA Type 1 or 2p-value: <0.000195% CI: [3.16, 7.54]Exact methods for risk difference
Comparison: Rapidly Progressive OA Type 1p-value: 0.036695% CI: [0.16, 3.92]Exact methods for risk difference
Comparison: Rapidly Progressive OA Type 1p-value: 0.000195% CI: [1.99, 6.12]Exact methods for risk difference
Comparison: Rapidly Progressive OA Type 2p-value: 0.616895% CI: [-0.76, 1.71]Exact methods for risk difference
Comparison: Rapidly Progressive OA Type 2p-value: 0.038895% CI: [0.17, 2.97]Exact methods for risk difference
Comparison: Primary osteonecrosisp-value: 0.724595% CI: [-0.74, 1.51]Exact methods for risk difference
Comparison: Primary osteonecrosisp-value: 0.718295% CI: [-0.74, 1.52]Exact methods for risk difference
Comparison: Subchondral insufficiency fracturep-value: 0.682495% CI: [-0.96, 1.9]Exact methods for risk difference
Comparison: Subchondral insufficiency fracturep-value: 0.563295% CI: [-0.86, 2.03]Exact methods for risk difference
Secondary
Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture.
Time frame: Baseline up to Week 80
Population: Safety population included all participants treated with tanezumab or placebo SC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | 8.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | 13.1 percentage of participants |
| NSAID | Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | 3.7 percentage of participants |
p-value: 0.000295% CI: [2.43, 7.74]Exact methods for risk difference
p-value: <0.000195% CI: [6.73, 12.52]Exact methods for risk difference
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). Here, 'Overall number of participants analyzed' signifies participants who discontinued from the study due to lack of efficacy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tanezumab 2.5 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tanezumab 5 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| NSAID | 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: 0.0074Log 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: 0.0162Log Rank
Secondary
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses
TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied\]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied\] and 1 question on 2 point scale \[0 =No, 1=Yes\]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction.
Time frame: Weeks 16 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'=participants evaluable for this outcome measure. Here, Number analyzed =participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Effectiveness | 64.26 units on a scale | Standard Error 1.03 |
| Tanezumab 2.5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Side Effects | 68.61 units on a scale | Standard Error 3.2 |
| Tanezumab 2.5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Convenience | 75.50 units on a scale | Standard Error 0.8 |
| Tanezumab 2.5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Global Satisfaction | 70.32 units on a scale | Standard Error 0.99 |
| Tanezumab 2.5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Effectiveness | 69.79 units on a scale | Standard Error 1.38 |
| Tanezumab 2.5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Side Effects | 78.62 units on a scale | Standard Error 5.28 |
| Tanezumab 2.5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Convenience | 78.03 units on a scale | Standard Error 1.12 |
| Tanezumab 2.5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Global Satisfaction | 75.31 units on a scale | Standard Error 1.27 |
| Tanezumab 5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Convenience | 75.78 units on a scale | Standard Error 0.79 |
| Tanezumab 5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Convenience | 77.67 units on a scale | Standard Error 1.1 |
| Tanezumab 5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Global Satisfaction | 70.69 units on a scale | Standard Error 0.98 |
| Tanezumab 5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Effectiveness | 67.91 units on a scale | Standard Error 1.36 |
| Tanezumab 5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Side Effects | 62.00 units on a scale | Standard Error 4.88 |
| Tanezumab 5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Effectiveness | 66.27 units on a scale | Standard Error 1.02 |
| Tanezumab 5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Side Effects | 73.32 units on a scale | Standard Error 3.09 |
| Tanezumab 5 mg | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Global Satisfaction | 73.37 units on a scale | Standard Error 1.25 |
| NSAID | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Convenience | 73.70 units on a scale | Standard Error 0.8 |
| NSAID | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Side Effects | 71.03 units on a scale | Standard Error 3.15 |
| NSAID | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Effectiveness | 61.61 units on a scale | Standard Error 1.03 |
| NSAID | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 16: Global Satisfaction | 67.13 units on a scale | Standard Error 0.99 |
| NSAID | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Convenience | 76.18 units on a scale | Standard Error 1.11 |
| NSAID | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Side Effects | 71.34 units on a scale | Standard Error 5.14 |
| NSAID | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Effectiveness | 67.64 units on a scale | Standard Error 1.38 |
| NSAID | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | Week 56: Global Satisfaction | 73.37 units on a scale | Standard Error 1.26 |
Comparison: TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.014295% CI: [0.53, 4.78]ANCOVA
Comparison: TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [2.56, 6.78]ANCOVA
Comparison: TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.137195% CI: [-0.69, 4.99]ANCOVA
Comparison: TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.852495% CI: [-2.6, 3.14]ANCOVA
Comparison: TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.525395% CI: [-9.93, 5.09]ANCOVA
Comparison: TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.538195% CI: [-5.04, 9.62]ANCOVA
Comparison: TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.269495% CI: [-5.99, 20.54]ANCOVA
Comparison: TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.134995% CI: [-21.8, 3.11]ANCOVA
Comparison: TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.026495% CI: [0.21, 3.38]ANCOVA
Comparison: TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.009895% CI: [0.5, 3.65]ANCOVA
Comparison: TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.093795% CI: [-0.31, 4.01]ANCOVA
Comparison: TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.183895% CI: [-0.7, 3.67]ANCOVA
Comparison: TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.002595% CI: [1.12, 5.25]ANCOVA
Comparison: TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000795% CI: [1.51, 5.6]ANCOVA
Comparison: TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.137395% CI: [-0.62, 4.51]ANCOVA
Comparison: TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.p-value: 0.99695% CI: [-2.59, 2.6]ANCOVA