Bone Metastases, Neoplasms
Conditions
Keywords
Cancer pain, NGF, open-label extension
Brief summary
To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone metastases who participated in the double-blind Study A4091003 and who wish to receive open-label therapy.
Interventions
BIOLOGICALAnti-NGF AB
Solution for injection, 10 mg, one injection/8 weeks
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has been diagnosed as having metastasized to bone; * Karnofsky Performance Score ≥40% at Baseline; * patients randomized and treated with intravenous study drug in double-blind Study A4091003.
Exclusion criteria
* Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event; * Occurrence of any adverse event or condition during Study A4091003 or since termination from that study that, in the opinion of the Investigator, would put the patient at increased safety risk or should exclude the subject from participating in the open-label extension Study A4091029.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain. |
| Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain. |
| Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain. |
| Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain. |
| Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain. |
| Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain. |
| Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain. |
| Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain. |
| Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing. |
| Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing. |
| Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with, general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. |
| Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. |
Countries
Austria, Bosnia and Herzegovina, Croatia, Hungary, India, Latvia, Poland, Slovakia, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tanezumab 10 mg (A4091029) Participants received a single intravenous (IV) infusion of tanezumab 10 milligram (mg) administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). For participants in Poland entering the Extended-use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 11 |
| Overall Study | Insufficient clinical response | 1 |
| Overall Study | Other - Unspecified | 1 |
| Overall Study | Progressive disease | 2 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Tanezumab 10 mg (A4091029) |
|---|---|
| Age, Continuous | 58.7 Years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 41 |
| serious Total, serious adverse events | 23 / 41 |
Outcome results
Primary
Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 (n=33) | -0.82 units on a scale | Standard Deviation 1.55 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 (n=29) | -0.69 units on a scale | Standard Deviation 1.28 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 (n=24) | -0.67 units on a scale | Standard Deviation 2.14 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 (n=21) | -1.19 units on a scale | Standard Deviation 1.75 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 (n=14) | -0.21 units on a scale | Standard Deviation 2.86 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 (n=1) | 0.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 (n=1) | 0.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 (n=1) | -3.00 units on a scale | — |
Primary
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with, general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Time frame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 16 | -1.00 units on a scale | Standard Deviation 2.93 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 8 | -1.00 units on a scale | Standard Deviation 2.04 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 16 | -1.50 units on a scale | Standard Deviation 2.97 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 16 | -1.36 units on a scale | Standard Deviation 3.2 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 24 | -1.00 units on a scale | Standard Deviation 2.75 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 24 | -1.40 units on a scale | Standard Deviation 2.99 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 16 | -1.00 units on a scale | Standard Deviation 2.95 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 40 | -1.17 units on a scale | Standard Deviation 2.23 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 40 | -1.50 units on a scale | Standard Deviation 2.81 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 24 | -2.20 units on a scale | Standard Deviation 2.9 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Baseline | -0.68 units on a scale | Standard Deviation 2.65 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 40 | -1.00 units on a scale | Standard Deviation 2.97 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Baseline | -1.00 units on a scale | Standard Deviation 2.89 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 24 | -1.60 units on a scale | Standard Deviation 1.71 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 4 | -2.18 units on a scale | Standard Deviation 2.32 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Baseline | -0.28 units on a scale | Standard Deviation 2.85 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 8 | -1.21 units on a scale | Standard Deviation 2.01 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Baseline | -1.58 units on a scale | Standard Deviation 1.98 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 16 | -1.09 units on a scale | Standard Deviation 1.81 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 4 | -1.41 units on a scale | Standard Deviation 3.43 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 24 | -0.60 units on a scale | Standard Deviation 1.9 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 8 | -1.47 units on a scale | Standard Deviation 2.17 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 40 | -0.17 units on a scale | Standard Deviation 1.83 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 16 | -1.00 units on a scale | Standard Deviation 2.28 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 4 | -2.33 units on a scale | Standard Deviation 1.78 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 24 | -1.10 units on a scale | Standard Deviation 2.33 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Baseline | -0.67 units on a scale | Standard Deviation 2.77 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Baseline | -1.39 units on a scale | Standard Deviation 2.99 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 40 | -0.67 units on a scale | Standard Deviation 2.88 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 4 | -2.53 units on a scale | Standard Deviation 2.92 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 40 | -0.83 units on a scale | Standard Deviation 1.72 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 8 | -1.71 units on a scale | Standard Deviation 2.64 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 4 | -1.65 units on a scale | Standard Deviation 2.57 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 16 | -1.09 units on a scale | Standard Deviation 2.43 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 8 | -2.27 units on a scale | Standard Deviation 2.43 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 24 | -2.00 units on a scale | Standard Deviation 2.36 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 8 | -0.86 units on a scale | Standard Deviation 2.25 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 40 | -1.00 units on a scale | Standard Deviation 3.58 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Baseline | -0.50 units on a scale | Standard Deviation 2.92 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 4 | -1.94 units on a scale | Standard Deviation 2.04 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 4 | -2.41 units on a scale | Standard Deviation 2.5 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 8 | -0.50 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 40 | -1.89 units on a scale | Standard Deviation 3.06 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 48 | -3.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 56 | -3.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 64 | -5.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Baseline | -1.00 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 4 | -1.59 units on a scale | Standard Deviation 2.53 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 8 | -1.47 units on a scale | Standard Deviation 3.16 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 16 | -1.85 units on a scale | Standard Deviation 3.02 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 24 | -2.08 units on a scale | Standard Deviation 2.75 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 40 | -3.11 units on a scale | Standard Deviation 3.18 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 48 | -5.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 56 | -5.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 64 | -5.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Baseline | -1.67 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 4 | -1.18 units on a scale | Standard Deviation 2.77 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 8 | -1.87 units on a scale | Standard Deviation 3.38 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 16 | -2.38 units on a scale | Standard Deviation 3.5 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 24 | -3.17 units on a scale | Standard Deviation 2.12 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 40 | -3.38 units on a scale | Standard Deviation 3.46 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 48 | -4.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 56 | -4.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 64 | -7.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 8 | -1.93 units on a scale | Standard Deviation 2.94 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Baseline | -1.39 units on a scale | Standard Deviation 2.57 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 4 | -1.76 units on a scale | Standard Deviation 2.11 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 8 | -2.27 units on a scale | Standard Deviation 2.19 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 16 | -1.31 units on a scale | Standard Deviation 3.09 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 24 | -2.17 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 40 | -2.78 units on a scale | Standard Deviation 3.03 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 48 | -3.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 56 | -3.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 64 | -6.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Baseline | -0.94 units on a scale | Standard Deviation 2.78 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 4 | -1.53 units on a scale | Standard Deviation 2.48 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 8 | -1.53 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 16 | -1.62 units on a scale | Standard Deviation 3.57 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 24 | -1.58 units on a scale | Standard Deviation 2.87 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 40 | -2.56 units on a scale | Standard Deviation 3.05 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 48 | -4.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 56 | -4.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 64 | -7.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Baseline | -0.17 units on a scale | Standard Deviation 2.57 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 4 | -0.24 units on a scale | Standard Deviation 2.25 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 8 | -0.73 units on a scale | Standard Deviation 1.83 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 16 | -0.23 units on a scale | Standard Deviation 1.88 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 24 | -0.92 units on a scale | Standard Deviation 1.88 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 40 | -0.63 units on a scale | Standard Deviation 3.07 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 48 | -3.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 56 | -4.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 64 | -5.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Baseline | -1.28 units on a scale | Standard Deviation 2.61 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 4 | -1.12 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 16 | -1.00 units on a scale | Standard Deviation 3.29 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 24 | -1.75 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 40 | -1.88 units on a scale | Standard Deviation 4.49 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 48 | 1.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 56 | 0.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 64 | -3.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Baseline | -1.28 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 4 | -1.41 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 8 | -1.47 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 16 | -1.31 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 24 | -1.92 units on a scale | Standard Deviation 2.31 |
Primary
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -2.28 units on a scale | Standard Deviation 1.96 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -1.00 units on a scale | Standard Deviation 1.67 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -1.67 units on a scale | Standard Deviation 2.53 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -1.40 units on a scale | Standard Deviation 1.76 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -2.50 units on a scale | Standard Deviation 1.84 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -1.05 units on a scale | Standard Deviation 2.04 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -2.67 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 | -3.0 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 | -3.0 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 | -3.0 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -1.28 units on a scale | Standard Deviation 2.14 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -2.18 units on a scale | Standard Deviation 2.07 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -2.60 units on a scale | Standard Deviation 1.64 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -3.31 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -3.25 units on a scale | Standard Deviation 1.82 |
Primary
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
Time frame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -2.03 units on a scale | Standard Deviation 2.02 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -0.90 units on a scale | Standard Deviation 2.04 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -1.05 units on a scale | Standard Deviation 2.35 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -1.22 units on a scale | Standard Deviation 1.49 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -1.41 units on a scale | Standard Deviation 1.84 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -0.81 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -2.38 units on a scale | Standard Deviation 2.89 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 | -3.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 | -3.29 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 | -5.43 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -1.10 units on a scale | Standard Deviation 2.11 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -1.26 units on a scale | Standard Deviation 1.91 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -1.61 units on a scale | Standard Deviation 2.13 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -1.38 units on a scale | Standard Deviation 2.56 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -1.94 units on a scale | Standard Deviation 1.87 |
Primary
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -1.67 units on a scale | Standard Deviation 1.94 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | 0.00 units on a scale | Standard Deviation 1.1 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -1.08 units on a scale | Standard Deviation 2.64 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -1.20 units on a scale | Standard Deviation 1.82 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -1.20 units on a scale | Standard Deviation 1.48 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -0.68 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -2.11 units on a scale | Standard Deviation 3.76 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 | -2.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 | -4.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 | -4.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -1.61 units on a scale | Standard Deviation 1.85 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -2.24 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -2.40 units on a scale | Standard Deviation 2.16 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -2.54 units on a scale | Standard Deviation 3.04 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -2.75 units on a scale | Standard Deviation 2.56 |
Primary
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -1.22 units on a scale | Standard Deviation 2.44 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -0.33 units on a scale | Standard Deviation 2.07 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -0.67 units on a scale | Standard Deviation 2.96 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -0.87 units on a scale | Standard Deviation 2.17 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -1.20 units on a scale | Standard Deviation 2.1 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -0.68 units on a scale | Standard Deviation 2.69 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -2.11 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 | -2.0 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 | -2.0 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 | -5.0 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -0.72 units on a scale | Standard Deviation 2.08 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -1.24 units on a scale | Standard Deviation 1.71 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -0.87 units on a scale | Standard Deviation 1.92 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -1.23 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -2.17 units on a scale | Standard Deviation 1.99 |
Primary
Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: The Intent to Treat (ITT) Population: all participants who received at least day 1 dose of IV study medication during Study A4091029. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -1.67 units on a scale | Standard Deviation 2.17 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | 0.50 units on a scale | Standard Deviation 1.38 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -1.58 units on a scale | Standard Deviation 2.02 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -1.33 units on a scale | Standard Deviation 1.5 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -1.60 units on a scale | Standard Deviation 1.58 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -1.00 units on a scale | Standard Deviation 2.16 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -2.44 units on a scale | Standard Deviation 2.65 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 | -1.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 | -1.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 | -4.00 units on a scale | — |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Baseline (A4091029) | -1.17 units on a scale | Standard Deviation 1.72 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -1.88 units on a scale | Standard Deviation 1.76 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -1.87 units on a scale | Standard Deviation 1.55 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -2.15 units on a scale | Standard Deviation 2.41 |
| Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -2.58 units on a scale | Standard Deviation 1.68 |
Primary
Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 4 | -0.85 units on a scale | Standard Deviation 1.84 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 8 | -1.10 units on a scale | Standard Deviation 2.27 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 16 | 0.04 units on a scale | Standard Deviation 2.9 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 24 | -0.90 units on a scale | Standard Deviation 2.32 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 40 | -0.57 units on a scale | Standard Deviation 2.93 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 48 | -1.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 56 | -1.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | General activity: Week 64 | -4.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 4 | -0.70 units on a scale | Standard Deviation 1.55 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 8 | -0.86 units on a scale | Standard Deviation 2.26 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 16 | -0.21 units on a scale | Standard Deviation 2.77 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 24 | -0.62 units on a scale | Standard Deviation 1.88 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 40 | -0.14 units on a scale | Standard Deviation 3.13 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 48 | -2.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 56 | -2.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Mood: Week 64 | -5.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 4 ( | -0.61 units on a scale | Standard Deviation 1.6 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 8 | -0.79 units on a scale | Standard Deviation 1.9 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 16 | -0.50 units on a scale | Standard Deviation 2.11 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 24 | -1.05 units on a scale | Standard Deviation 2.06 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 40 | -1.08 units on a scale | Standard Deviation 2.9 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 48 | -2.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 56 | -3.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Walking ability: Week 64 | -4.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 4 | -0.42 units on a scale | Standard Deviation 2.02 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 8 | -0.62 units on a scale | Standard Deviation 2.41 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 16 | 0.08 units on a scale | Standard Deviation 2.78 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 24 | -0.76 units on a scale | Standard Deviation 1.87 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 40 | -0.46 units on a scale | Standard Deviation 3.36 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 48 | -1.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal work: Week 56 | -2.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Normal Work: Week 64 | -5.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 4 | -1.18 units on a scale | Standard Deviation 2.05 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 8 | -0.86 units on a scale | Standard Deviation 2.43 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 16 | -0.67 units on a scale | Standard Deviation 2.46 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 24 | -1.19 units on a scale | Standard Deviation 2.09 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 40 | -0.71 units on a scale | Standard Deviation 2.7 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 48 | -3.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 56 | -3.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Relations with other people: Week 64 | -5.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 4 | -0.94 units on a scale | Standard Deviation 1.6 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 8 | -0.76 units on a scale | Standard Deviation 2.15 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 16 | -0.63 units on a scale | Standard Deviation 2.73 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 24 | -0.86 units on a scale | Standard Deviation 2.2 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 40 | -0.71 units on a scale | Standard Deviation 2.76 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 48 | -1.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 56 | -1.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Sleep: Week 64 | -1.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 4 | -0.12 units on a scale | Standard Deviation 1.75 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 8 | -0.55 units on a scale | Standard Deviation 2.57 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 16 | -0.17 units on a scale | Standard Deviation 3.12 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 24 | -0.81 units on a scale | Standard Deviation 2.4 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 40 | -0.08 units on a scale | Standard Deviation 3.75 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 48 | -2.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 56 | -2.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Enjoyment of life: Week 64 | -5.00 units on a scale | — |
Primary
Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -1.15 units on a scale | Standard Deviation 1.46 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -1.00 units on a scale | Standard Deviation 1.36 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -1.08 units on a scale | Standard Deviation 1.93 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -1.81 units on a scale | Standard Deviation 1.6 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -1.00 units on a scale | Standard Deviation 2.11 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 | -1.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 | -1.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 | -1.00 units on a scale | — |
Primary
Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -0.69 units on a scale | Standard Deviation 1.33 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -0.79 units on a scale | Standard Deviation 1.9 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -0.29 units on a scale | Standard Deviation 2.46 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -0.88 units on a scale | Standard Deviation 1.77 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -0.56 units on a scale | Standard Deviation 2.81 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 | -1.71 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 | -2.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 | -4.14 units on a scale | — |
Primary
Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -0.82 units on a scale | Standard Deviation 1.61 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -0.72 units on a scale | Standard Deviation 1.62 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -0.67 units on a scale | Standard Deviation 2.62 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -0.95 units on a scale | Standard Deviation 1.72 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -0.21 units on a scale | Standard Deviation 3.49 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 | -1.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 | -3.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 | -3.00 units on a scale | — |
Primary
Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Population: ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 64 | -3.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 4 | -0.82 units on a scale | Standard Deviation 1.83 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 8 | -0.48 units on a scale | Standard Deviation 1.72 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 16 | -0.25 units on a scale | Standard Deviation 2.92 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 24 | -1.14 units on a scale | Standard Deviation 2.2 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 40 | -0.36 units on a scale | Standard Deviation 2.87 |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 48 | 0.00 units on a scale | — |
| Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 | Week 56 | 0.00 units on a scale | — |