Trial Outcomes & Findings for Open Label Extension In Cancer Patients (NCT NCT00830180)
NCT ID: NCT00830180
Last Updated: 2021-04-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Results posted on
2021-04-05
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
Received Tanezumab in Parent Study A4091003
|
19
|
|
Overall Study
Received Placebo in Parent Study A4091003
|
22
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Death
|
11
|
|
Overall Study
Insufficient clinical response
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Progressive disease
|
2
|
|
Overall Study
Other - Unspecified
|
1
|
Baseline Characteristics
Open Label Extension In Cancer Patients
Baseline characteristics by cohort
| Measure |
Tanezumab 10 mg (A4091029)
n=41 Participants
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.
|
|---|---|
|
Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 12.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=19 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=18 Participants
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
-1.88 units on a scale
Standard Deviation 1.76
|
|
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
|
-1.17 units on a scale
Standard Deviation 1.72
|
|
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 1.50
|
-1.87 units on a scale
Standard Deviation 1.55
|
|
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
|
-2.15 units on a scale
Standard Deviation 2.41
|
|
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
|
-2.58 units on a scale
Standard Deviation 1.68
|
|
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
|
-2.44 units on a scale
Standard Deviation 2.65
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=33 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=19 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=18 Participants
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
-0.72 units on a scale
Standard Deviation 2.08
|
|
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
|
-1.24 units on a scale
Standard Deviation 1.71
|
|
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
|
-0.87 units on a scale
Standard Deviation 1.92
|
|
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
|
-1.23 units on a scale
Standard Deviation 2.68
|
|
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 2.10
|
-2.17 units on a scale
Standard Deviation 1.99
|
|
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
|
-2.11 units on a scale
Standard Deviation 2.62
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=33 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 2.20
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
PRIMARY outcome
Timeframe: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=19 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=18 Participants
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
-1.28 units on a scale
Standard Deviation 2.14
|
|
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
|
-2.18 units on a scale
Standard Deviation 2.07
|
|
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
|
-2.60 units on a scale
Standard Deviation 1.64
|
|
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
|
-3.31 units on a scale
Standard Deviation 2.32
|
|
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
|
-3.25 units on a scale
Standard Deviation 1.82
|
|
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
|
-2.67 units on a scale
Standard Deviation 2.83
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=33 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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 1.60
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
PRIMARY outcome
Timeframe: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=19 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=18 Participants
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
-2.54 units on a scale
Standard Deviation 3.04
|
|
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
|
-1.61 units on a scale
Standard Deviation 1.85
|
|
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
|
-2.24 units on a scale
Standard Deviation 2.31
|
|
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
|
-2.40 units on a scale
Standard Deviation 2.16
|
|
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
|
-2.75 units on a scale
Standard Deviation 2.56
|
|
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 1.10
|
-2.11 units on a scale
Standard Deviation 3.76
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=33 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=18 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=18 Participants
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
-1.10 units on a scale
Standard Deviation 2.11
|
|
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
|
-1.26 units on a scale
Standard Deviation 1.91
|
|
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
|
-1.61 units on a scale
Standard Deviation 2.13
|
|
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
|
-1.38 units on a scale
Standard Deviation 2.56
|
|
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
|
-1.94 units on a scale
Standard Deviation 1.87
|
|
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
|
-2.38 units on a scale
Standard Deviation 2.89
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=33 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 1.90
|
—
|
|
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
|
—
|
PRIMARY outcome
Timeframe: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=19 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=18 Participants
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
-0.24 units on a scale
Standard Deviation 2.25
|
|
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
|
-1.39 units on a scale
Standard Deviation 2.57
|
|
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
|
-1.76 units on a scale
Standard Deviation 2.11
|
|
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
|
-2.27 units on a scale
Standard Deviation 2.19
|
|
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
|
-1.31 units on a scale
Standard Deviation 3.09
|
|
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
|
-2.17 units on a scale
Standard Deviation 2.37
|
|
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
|
-2.78 units on a scale
Standard Deviation 3.03
|
|
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
|
|
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
|
|
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
|
|
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
|
-0.94 units on a scale
Standard Deviation 2.78
|
|
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
|
-1.53 units on a scale
Standard Deviation 2.48
|
|
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
|
-1.53 units on a scale
Standard Deviation 2.72
|
|
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
|
-1.62 units on a scale
Standard Deviation 3.57
|
|
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 2.90
|
-1.58 units on a scale
Standard Deviation 2.87
|
|
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
|
-2.56 units on a scale
Standard Deviation 3.05
|
|
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
|
|
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
|
|
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
|
|
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
|
-0.17 units on a scale
Standard Deviation 2.57
|
|
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
|
-0.73 units on a scale
Standard Deviation 1.83
|
|
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
|
-0.23 units on a scale
Standard Deviation 1.88
|
|
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
|
-0.92 units on a scale
Standard Deviation 1.88
|
|
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
|
-0.63 units on a scale
Standard Deviation 3.07
|
|
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
|
|
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
|
|
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
|
|
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
|
-1.28 units on a scale
Standard Deviation 2.61
|
|
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
|
-1.12 units on a scale
Standard Deviation 2.74
|
|
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
|
-1.93 units on a scale
Standard Deviation 2.94
|
|
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
|
-1.00 units on a scale
Standard Deviation 3.29
|
|
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
|
-1.75 units on a scale
Standard Deviation 2.83
|
|
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
|
-1.88 units on a scale
Standard Deviation 4.49
|
|
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
|
|
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
|
|
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
|
|
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
|
-1.28 units on a scale
Standard Deviation 2.44
|
|
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 3.20
|
-1.31 units on a scale
Standard Deviation 2.50
|
|
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 1.90
|
-2.08 units on a scale
Standard Deviation 2.75
|
|
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
|
|
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
|
-1.18 units on a scale
Standard Deviation 2.77
|
|
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 2.50
|
-1.41 units on a scale
Standard Deviation 2.29
|
|
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
|
-1.47 units on a scale
Standard Deviation 2.64
|
|
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
|
-1.92 units on a scale
Standard Deviation 2.31
|
|
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
|
-1.89 units on a scale
Standard Deviation 3.06
|
|
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
|
|
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
|
|
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
|
|
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
|
-1.00 units on a scale
Standard Deviation 2.43
|
|
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
|
-1.59 units on a scale
Standard Deviation 2.53
|
|
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
|
-1.47 units on a scale
Standard Deviation 3.16
|
|
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
|
-1.85 units on a scale
Standard Deviation 3.02
|
|
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
|
-3.11 units on a scale
Standard Deviation 3.18
|
|
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
|
|
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
|
|
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
|
-1.67 units on a scale
Standard Deviation 2.72
|
|
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
|
-1.87 units on a scale
Standard Deviation 3.38
|
|
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
|
-2.38 units on a scale
Standard Deviation 3.50
|
|
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
|
-3.17 units on a scale
Standard Deviation 2.12
|
|
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
|
-3.38 units on a scale
Standard Deviation 3.46
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029Population: 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.
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.
Outcome measures
| Measure |
Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
n=33 Participants
Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 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). 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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 2.90
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 1.60
|
—
|
|
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 1.90
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 2.90
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 2.70
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 1.60
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 2.20
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 2.40
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
Adverse Events
Tanezumab 10 mg (A4091029)
Serious events: 23 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tanezumab 10 mg (A4091029)
n=41 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
4/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
4.9%
2/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
4.9%
2/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
7.3%
3/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
4.9%
2/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Disease progression
|
7.3%
3/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchopneumonia
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cerebral infarction
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
1/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Tanezumab 10 mg (A4091029)
n=41 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
3/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.2%
5/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
3/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
7.3%
3/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
19.5%
8/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
4/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
14.6%
6/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
12.2%
5/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
12.2%
5/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
7.3%
3/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.3%
3/41
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60