Osteoarthritis
Conditions
Brief summary
A4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. The study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. There will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet).
Detailed description
A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.
Interventions
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
Sponsors
Eli Lilly and Company
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Personally signed and dated informed consent document. * Randomized and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study. * Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab study. * Willing and able to comply with scheduled visits and other study procedures.
Exclusion criteria
\- None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgeon's Assessment of Procedural Difficulty | Day 1 | Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications. Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint. |
| Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Week 24 | SAPS contained four questions; How satisfied are you with the 1) results of your surgery 2) results of surgery for improving pain 3) results of surgery for improving ability to do home or yard work, and 4) results of surgery for improving your ability to do recreational activities. Items scored on a 4-point Likert scale with response of 'very satisfied' (100 points), 'somewhat satisfied' (75 points), 'somewhat dissatisfied' (50 points), and 'very dissatisfied' (25 points). The scale score calculated as mean of the scores of individual items, ranging from 25 to 100, with higher scores indicating greater satisfaction. Here, number of participants are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Participants may have been counted more than once if they had TJR surgery in more than one joint. |
| Number of Participants With Post-Surgical Complications Upto Week 24 | Baseline up to Week 24 | Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Participants may have been counted more than once if they had TJR surgery in more than one joint. |
| Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Baseline up to Week 24 | Participants were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Participants, who responded as yes have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint. |
| Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Baseline up to Week 24 | Participants responded with a yes or no to the following question ''are you participating in physical rehabilitation activities related to your replaced joint''. Participants responded with a yes, have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint. |
| Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Baseline, Week 24 | Participants assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline, Week 24 | WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. 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 was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline, Week 24 | 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 replaced/to be replaced 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 was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline, Week 24 | 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 replaced/ to be replaced 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. Participants may have been counted more than once if they had TJR surgery in more than one joint. |
| Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 | Baseline, Week 24 | SPADI: self-administered questionnaire to measure pain and disability associated with shoulder pathology in participants with shoulder pain. It consists of two dimensions pain and function. Pain dimension:5 questions regarding severity of pain, scores ranged from 0=no pain to 10=worst pain imaginable, higher scores indicated extreme pain. Functional activities:8 questions to measure degree of difficulty with various activities of daily living that require upper extremity use, scores ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as the sum of non-missing scores divided by the maximum possible score (50 \[for pain\] and 80 \[for disability\]) multiplied by 100. A total score was calculated as the mean of two dimensions, ranged from 0=best to 100=worst, higher scores indicated worsening of condition. |
| Number of Participants Who Used Concomitant Analgesic Medications | Baseline up to Week 24 | — |
Countries
Australia, Canada, Germany, Hungary, Italy, Japan, Lithuania, New Zealand, Portugal, Russia, Serbia, Slovakia, Spain, Sweden, United States
Participant flow
Recruitment details
This study included participants from studies A4091056 (NCT02697773), A4091057 (NCT02709486) and A4091058 (NCT02528188) who had undergone a total joint replacement (TJR) surgery of knee, hip, or shoulder. During this study, if participant underwent an additional TJR surgery, then data for that additional TJR surgery was also assessed.
Pre-assignment details
Pre-specified intent of this study was to compare results regardless of treatment group/doses in parent studies and also to report data for overall (combined participants from all parent studies).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | 20 |
| Tanezumab Combined Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | 113 |
| NSAID Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | 17 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Enrolled but not evaluated | 0 | 4 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | NSAID | Tanezumab Combined |
|---|---|---|---|---|
| Age, Continuous | 65.26 Years STANDARD_DEVIATION 8.77 | 64.47 Years STANDARD_DEVIATION 8.33 | 62.94 Years STANDARD_DEVIATION 9.13 | 64.57 Years STANDARD_DEVIATION 8.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 7 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 141 Participants | 14 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 9 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 131 Participants | 14 Participants | 100 Participants |
| Sex/Gender, Customized Female | 13 Participants | 88 Participants | 13 Participants | 62 Participants |
| Sex/Gender, Customized Male | 6 Participants | 60 Participants | 4 Participants | 50 Participants |
| Sex/Gender, Customized Unspecified | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 52 | 0 / 8 | 0 / 53 | 0 / 113 | 0 / 17 | 0 / 150 |
| other Total, other adverse events | 0 / 20 | 9 / 52 | 3 / 8 | 9 / 53 | 21 / 113 | 4 / 17 | 25 / 150 |
| serious Total, serious adverse events | 0 / 20 | 5 / 52 | 3 / 8 | 7 / 53 | 15 / 113 | 2 / 17 | 17 / 150 |
Outcome results
Primary
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24
Participants assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time frame: Baseline, Week 24
Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'n' = participants evaluable for this OM at specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Baseline: Knee | 6.00 units on a scale | Standard Deviation 2.31 |
| Placebo | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Baseline: Hip | 6.10 units on a scale | Standard Deviation 2.13 |
| Placebo | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Change at Week 24: Knee | -4.56 units on a scale | Standard Deviation 1.24 |
| Placebo | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Change at Week 24: Hip | -5.20 units on a scale | Standard Deviation 2.3 |
| Tanezumab Combined | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Baseline: Hip | 6.81 units on a scale | Standard Deviation 2.27 |
| Tanezumab Combined | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Change at Week 24: Knee | -5.32 units on a scale | Standard Deviation 2.63 |
| Tanezumab Combined | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Change at Week 24: Hip | -5.67 units on a scale | Standard Deviation 2.37 |
| Tanezumab Combined | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Baseline: Knee | 6.86 units on a scale | Standard Deviation 2.14 |
| NSAID | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Change at Week 24: Knee | -5.43 units on a scale | Standard Deviation 2.51 |
| NSAID | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Baseline: Hip | 5.86 units on a scale | Standard Deviation 3.44 |
| NSAID | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Change at Week 24: Hip | -5.00 units on a scale | Standard Deviation 4.1 |
| NSAID | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Baseline: Knee | 6.80 units on a scale | Standard Deviation 2.2 |
| All Participants | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Change at Week 24: Hip | -5.52 units on a scale | Standard Deviation 2.53 |
| All Participants | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Baseline: Hip | 6.60 units on a scale | Standard Deviation 2.38 |
| All Participants | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Baseline: Knee | 6.76 units on a scale | Standard Deviation 2.16 |
| All Participants | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 | Change at Week 24: Knee | -5.24 units on a scale | Standard Deviation 2.49 |
Primary
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24
SPADI: self-administered questionnaire to measure pain and disability associated with shoulder pathology in participants with shoulder pain. It consists of two dimensions pain and function. Pain dimension:5 questions regarding severity of pain, scores ranged from 0=no pain to 10=worst pain imaginable, higher scores indicated extreme pain. Functional activities:8 questions to measure degree of difficulty with various activities of daily living that require upper extremity use, scores ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as the sum of non-missing scores divided by the maximum possible score (50 \[for pain\] and 80 \[for disability\]) multiplied by 100. A total score was calculated as the mean of two dimensions, ranged from 0=best to 100=worst, higher scores indicated worsening of condition.
Time frame: Baseline, Week 24
Population: Enrolled participants who received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had qualifying shoulder replacement. N=those participants who had data available for this OM, hence data for Placebo and Tanezumab reporting groups were not collected as no participants were evaluable for this OM.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| NSAID | Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 | Baseline | 89.88 units on a scale |
| NSAID | Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 | Change at Week 24 | -89.88 units on a scale |
| All Participants | Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 | Baseline | 89.88 units on a scale |
| All Participants | Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 | Change at Week 24 | -89.88 units on a scale |
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. 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 was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time frame: Baseline, Week 24
Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline: Knee | 4.66 units on a scale | Standard Deviation 3.05 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline: Hip | 4.80 units on a scale | Standard Deviation 2.61 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24: Knee | -3.13 units on a scale | Standard Deviation 1.74 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24: Hip | -4.34 units on a scale | Standard Deviation 2.52 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline: Hip | 5.97 units on a scale | Standard Deviation 2.46 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24: Knee | -4.50 units on a scale | Standard Deviation 2.43 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24: Hip | -4.92 units on a scale | Standard Deviation 2.62 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline: Knee | 5.62 units on a scale | Standard Deviation 2.33 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24: Knee | -4.54 units on a scale | Standard Deviation 3.15 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline: Hip | 6.13 units on a scale | Standard Deviation 1.98 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24: Hip | -5.92 units on a scale | Standard Deviation 2.4 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline: Knee | 6.11 units on a scale | Standard Deviation 2.31 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24: Hip | -4.91 units on a scale | Standard Deviation 2.57 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline: Hip | 5.80 units on a scale | Standard Deviation 2.45 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline: Knee | 5.56 units on a scale | Standard Deviation 2.41 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24: Knee | -4.34 units on a scale | Standard Deviation 2.44 |
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
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 replaced/ to be replaced 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. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time frame: Baseline, Week 24
Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline: Knee | 4.83 units on a scale | Standard Deviation 2.99 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline: Hip | 5.56 units on a scale | Standard Deviation 2.21 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24: Knee | -2.69 units on a scale | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24: Hip | -4.64 units on a scale | Standard Deviation 2.13 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline: Hip | 6.50 units on a scale | Standard Deviation 2.22 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24: Knee | -4.42 units on a scale | Standard Deviation 2.19 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24: Hip | -5.05 units on a scale | Standard Deviation 2.44 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline: Knee | 5.82 units on a scale | Standard Deviation 2.11 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24: Knee | -4.59 units on a scale | Standard Deviation 2.9 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline: Hip | 6.86 units on a scale | Standard Deviation 1.48 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24: Hip | -5.95 units on a scale | Standard Deviation 1.84 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline: Knee | 6.63 units on a scale | Standard Deviation 1.98 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24: Hip | -5.06 units on a scale | Standard Deviation 2.33 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline: Hip | 6.38 units on a scale | Standard Deviation 2.17 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline: Knee | 5.79 units on a scale | Standard Deviation 2.23 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24: Knee | -4.24 units on a scale | Standard Deviation 2.24 |
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24
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 replaced/to be replaced 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 was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time frame: Baseline, Week 24
Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline: Knee | 4.80 units on a scale | Standard Deviation 2.78 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline: Hip | 4.70 units on a scale | Standard Deviation 2.75 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24: Knee | -1.78 units on a scale | Standard Deviation 1.52 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24: Hip | -4.00 units on a scale | Standard Deviation 2.66 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline: Hip | 5.96 units on a scale | Standard Deviation 2.69 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24: Knee | -4.13 units on a scale | Standard Deviation 2.58 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24: Hip | -4.48 units on a scale | Standard Deviation 2.87 |
| Tanezumab Combined | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline: Knee | 5.75 units on a scale | Standard Deviation 2.52 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24: Knee | -3.43 units on a scale | Standard Deviation 3.13 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline: Hip | 5.25 units on a scale | Standard Deviation 3.5 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24: Hip | -3.80 units on a scale | Standard Deviation 3.7 |
| NSAID | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline: Knee | 6.44 units on a scale | Standard Deviation 2.58 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24: Hip | -4.33 units on a scale | Standard Deviation 2.86 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline: Hip | 5.69 units on a scale | Standard Deviation 2.77 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline: Knee | 5.71 units on a scale | Standard Deviation 2.55 |
| All Participants | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24: Knee | -3.79 units on a scale | Standard Deviation 2.62 |
Primary
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24
Participants responded with a yes or no to the following question ''are you participating in physical rehabilitation activities related to your replaced joint''. Participants responded with a yes, have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time frame: Baseline up to Week 24
Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Knee | 10 Participants |
| Placebo | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Shoulder | 0 Participants |
| Placebo | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Hip | 9 Participants |
| Tanezumab Combined | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Knee | 55 Participants |
| Tanezumab Combined | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Shoulder | 0 Participants |
| Tanezumab Combined | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Hip | 33 Participants |
| NSAID | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Hip | 3 Participants |
| NSAID | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Knee | 7 Participants |
| NSAID | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Shoulder | 1 Participants |
| All Participants | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Knee | 72 Participants |
| All Participants | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Shoulder | 1 Participants |
| All Participants | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 | Hip | 45 Participants |
Primary
Number of Participants Who Used Concomitant Analgesic Medications
Time frame: Baseline up to Week 24
Population: Safety analysis set: all enrolled participants of this study who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Used Concomitant Analgesic Medications | 18 Participants |
| Tanezumab Combined | Number of Participants Who Used Concomitant Analgesic Medications | 100 Participants |
| NSAID | Number of Participants Who Used Concomitant Analgesic Medications | 15 Participants |
| All Participants | Number of Participants Who Used Concomitant Analgesic Medications | 133 Participants |
Primary
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24
Participants were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Participants, who responded as yes have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time frame: Baseline up to Week 24
Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Knee | 0 Participants |
| Placebo | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Shoulder | 0 Participants |
| Placebo | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Hip | 0 Participants |
| Tanezumab Combined | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Knee | 4 Participants |
| Tanezumab Combined | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Shoulder | 0 Participants |
| Tanezumab Combined | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Hip | 5 Participants |
| NSAID | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Hip | 1 Participants |
| NSAID | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Knee | 0 Participants |
| NSAID | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Shoulder | 0 Participants |
| All Participants | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Knee | 4 Participants |
| All Participants | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Shoulder | 0 Participants |
| All Participants | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 | Hip | 6 Participants |
Primary
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24
SAPS contained four questions; How satisfied are you with the 1) results of your surgery 2) results of surgery for improving pain 3) results of surgery for improving ability to do home or yard work, and 4) results of surgery for improving your ability to do recreational activities. Items scored on a 4-point Likert scale with response of 'very satisfied' (100 points), 'somewhat satisfied' (75 points), 'somewhat dissatisfied' (50 points), and 'very dissatisfied' (25 points). The scale score calculated as mean of the scores of individual items, ranging from 25 to 100, with higher scores indicating greater satisfaction. Here, number of participants are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time frame: Week 24
Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability for home or yard work | Satisfied | 9 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder:Improving ability-recreational activities | Dissatisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Satisfaction with result of surgery | Satisfied | 9 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Satisfaction with result of surgery | Dissatisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Results of surgery for relieving pain | Satisfied | 9 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Results of surgery for relieving pain | Dissatisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder:Improving ability-recreational activities | Satisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability for home or yard work | Dissatisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability-recreational activities | Satisfied | 9 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability-recreational activities | Dissatisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Satisfaction with result of surgery | Satisfied | 9 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Satisfaction with result of surgery | Dissatisfied | 1 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Results of surgery for relieving pain | Satisfied | 9 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Results of surgery for relieving pain | Dissatisfied | 1 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability for home or yard work | Satisfied | 9 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability for home or yard work | Dissatisfied | 1 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability-recreational activities | Satisfied | 9 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability-recreational activities | Dissatisfied | 1 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Satisfaction with result of surgery | Satisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Satisfaction with result of surgery | Dissatisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Results of surgery for relieving pain | Satisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Results of surgery for relieving pain | Dissatisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Improving ability for home or yard work | Satisfied | 0 Participants |
| Placebo | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Improving ability for home or yard work | Dissatisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Improving ability for home or yard work | Dissatisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Results of surgery for relieving pain | Satisfied | 41 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Satisfaction with result of surgery | Dissatisfied | 5 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Improving ability for home or yard work | Satisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Results of surgery for relieving pain | Dissatisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Results of surgery for relieving pain | Dissatisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability-recreational activities | Satisfied | 50 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability-recreational activities | Satisfied | 40 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Results of surgery for relieving pain | Dissatisfied | 6 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability for home or yard work | Satisfied | 41 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Satisfaction with result of surgery | Satisfied | 53 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability for home or yard work | Dissatisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Results of surgery for relieving pain | Satisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability-recreational activities | Dissatisfied | 8 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Satisfaction with result of surgery | Dissatisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder:Improving ability-recreational activities | Dissatisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability for home or yard work | Dissatisfied | 10 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Satisfaction with result of surgery | Satisfied | 40 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability for home or yard work | Satisfied | 48 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Satisfaction with result of surgery | Satisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder:Improving ability-recreational activities | Satisfied | 0 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Satisfaction with result of surgery | Dissatisfied | 1 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Results of surgery for relieving pain | Satisfied | 52 Participants |
| Tanezumab Combined | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability-recreational activities | Dissatisfied | 1 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Satisfaction with result of surgery | Satisfied | 6 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability for home or yard work | Satisfied | 5 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability for home or yard work | Dissatisfied | 1 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability-recreational activities | Satisfied | 5 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability-recreational activities | Dissatisfied | 1 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Results of surgery for relieving pain | Satisfied | 1 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Satisfaction with result of surgery | Dissatisfied | 0 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Satisfaction with result of surgery | Dissatisfied | 0 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Results of surgery for relieving pain | Satisfied | 6 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Results of surgery for relieving pain | Dissatisfied | 0 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Results of surgery for relieving pain | Dissatisfied | 0 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability for home or yard work | Satisfied | 6 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability for home or yard work | Dissatisfied | 0 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Improving ability for home or yard work | Dissatisfied | 0 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability-recreational activities | Satisfied | 6 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability-recreational activities | Dissatisfied | 0 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Improving ability for home or yard work | Satisfied | 1 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder:Improving ability-recreational activities | Satisfied | 1 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder:Improving ability-recreational activities | Dissatisfied | 0 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Satisfaction with result of surgery | Satisfied | 1 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Satisfaction with result of surgery | Satisfied | 5 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Satisfaction with result of surgery | Dissatisfied | 1 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Results of surgery for relieving pain | Satisfied | 5 Participants |
| NSAID | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Results of surgery for relieving pain | Dissatisfied | 1 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Improving ability for home or yard work | Satisfied | 1 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Results of surgery for relieving pain | Satisfied | 1 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability for home or yard work | Dissatisfied | 11 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder:Improving ability-recreational activities | Satisfied | 1 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Satisfaction with result of surgery | Satisfied | 55 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability-recreational activities | Dissatisfied | 9 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Results of surgery for relieving pain | Dissatisfied | 7 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder:Improving ability-recreational activities | Dissatisfied | 0 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Results of surgery for relieving pain | Satisfied | 66 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability-recreational activities | Satisfied | 64 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Satisfaction with result of surgery | Dissatisfied | 0 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Satisfaction with result of surgery | Satisfied | 67 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Results of surgery for relieving pain | Dissatisfied | 0 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability for home or yard work | Satisfied | 56 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Satisfaction with result of surgery | Satisfied | 1 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability for home or yard work | Dissatisfied | 1 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Shoulder: Improving ability for home or yard work | Dissatisfied | 0 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Results of surgery for relieving pain | Dissatisfied | 1 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Improving ability for home or yard work | Satisfied | 62 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability-recreational activities | Satisfied | 55 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Results of surgery for relieving pain | Satisfied | 56 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Satisfaction with result of surgery | Dissatisfied | 2 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Knee: Satisfaction with result of surgery | Dissatisfied | 6 Participants |
| All Participants | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 | Hip: Improving ability-recreational activities | Dissatisfied | 2 Participants |
Primary
Number of Participants With Post-Surgical Complications Upto Week 24
Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time frame: Baseline up to Week 24
Population: Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Post-Surgical Complications Upto Week 24 | Knee | 0 Participants |
| Placebo | Number of Participants With Post-Surgical Complications Upto Week 24 | Shoulder | 0 Participants |
| Placebo | Number of Participants With Post-Surgical Complications Upto Week 24 | Hip | 0 Participants |
| Tanezumab Combined | Number of Participants With Post-Surgical Complications Upto Week 24 | Knee | 1 Participants |
| Tanezumab Combined | Number of Participants With Post-Surgical Complications Upto Week 24 | Shoulder | 0 Participants |
| Tanezumab Combined | Number of Participants With Post-Surgical Complications Upto Week 24 | Hip | 5 Participants |
| NSAID | Number of Participants With Post-Surgical Complications Upto Week 24 | Hip | 0 Participants |
| NSAID | Number of Participants With Post-Surgical Complications Upto Week 24 | Knee | 0 Participants |
| NSAID | Number of Participants With Post-Surgical Complications Upto Week 24 | Shoulder | 0 Participants |
| All Participants | Number of Participants With Post-Surgical Complications Upto Week 24 | Knee | 1 Participants |
| All Participants | Number of Participants With Post-Surgical Complications Upto Week 24 | Shoulder | 0 Participants |
| All Participants | Number of Participants With Post-Surgical Complications Upto Week 24 | Hip | 5 Participants |
Primary
Number of Participants With Surgeon's Assessment of Procedural Difficulty
Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications. Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time frame: Day 1
Population: Safety analysis set analyzed. Here, 'Overall number of participants analyzed (N)' = only those participants who had data available for this outcome measure (OM). 'Number analyzed (n)' = participants evaluable for this OM at specified categories.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Uneventful | 9 Participants |
| Placebo | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Minor Complications | 0 Participants |
| Placebo | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Major Complications | 0 Participants |
| Placebo | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Minor Complications | 0 Participants |
| Placebo | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Uneventful | 8 Participants |
| Placebo | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Major Complications | 0 Participants |
| Placebo | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Uneventful | 0 Participants |
| Placebo | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Major Complications | 0 Participants |
| Placebo | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Minor Complications | 0 Participants |
| Tanezumab Combined | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Major Complications | 0 Participants |
| Tanezumab Combined | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Major Complications | 0 Participants |
| Tanezumab Combined | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Uneventful | 49 Participants |
| Tanezumab Combined | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Major Complications | 0 Participants |
| Tanezumab Combined | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Minor Complications | 4 Participants |
| Tanezumab Combined | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Uneventful | 0 Participants |
| Tanezumab Combined | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Uneventful | 37 Participants |
| Tanezumab Combined | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Minor Complications | 0 Participants |
| Tanezumab Combined | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Minor Complications | 2 Participants |
| NSAID | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Major Complications | 0 Participants |
| NSAID | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Minor Complications | 0 Participants |
| NSAID | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Major Complications | 0 Participants |
| NSAID | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Uneventful | 1 Participants |
| NSAID | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Minor Complications | 0 Participants |
| NSAID | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Uneventful | 8 Participants |
| NSAID | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Minor Complications | 0 Participants |
| NSAID | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Major Complications | 0 Participants |
| NSAID | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Uneventful | 4 Participants |
| All Participants | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Minor Complications | 4 Participants |
| All Participants | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Minor Complications | 2 Participants |
| All Participants | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Uneventful | 1 Participants |
| All Participants | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Uneventful | 49 Participants |
| All Participants | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Major Complications | 0 Participants |
| All Participants | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Hip | Major Complications | 0 Participants |
| All Participants | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Knee | Uneventful | 66 Participants |
| All Participants | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Major Complications | 0 Participants |
| All Participants | Number of Participants With Surgeon's Assessment of Procedural Difficulty | Shoulder | Minor Complications | 0 Participants |