Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open Label Extension In Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00830180
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : February 2, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neoplasms
Bone Metastases
Intervention Biological: Anti-NGF AB
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tanezumab 10 mg (A4091029)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 41
Received Tanezumab in Parent Study A4091003 19
Received Placebo in Parent Study A4091003 22
Completed 15
Not Completed 26
Reason Not Completed
Adverse Event             6
Death             11
Insufficient clinical response             1
Withdrawal by Subject             5
Progressive disease             2
Other - Unspecified             1
Arm/Group Title Tanezumab 10 mg (A4091029)
Hide Arm/Group Description 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 Number of Baseline Participants 41
Hide Baseline Analysis Population Description
The intent to treat (ITT) analysis set included all participants who received at least 1 of IV study medication during study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
58.7  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
21
  51.2%
Male
20
  48.8%
1.Primary Outcome
Title 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
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat (ITT) Population: all participants who received at least day 1 dose of IV study medication during Study A4091029. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (A4091029) Number Analyzed 19 participants 18 participants
-1.00  (2.16) -1.17  (1.72)
Week 4 Number Analyzed 18 participants 17 participants
-1.67  (2.17) -1.88  (1.76)
Week 8 Number Analyzed 15 participants 15 participants
-1.33  (1.50) -1.87  (1.55)
Week 16 Number Analyzed 12 participants 13 participants
-1.58  (2.02) -2.15  (2.41)
Week 24 Number Analyzed 10 participants 12 participants
-1.60  (1.58) -2.58  (1.68)
Week 40 Number Analyzed 6 participants 9 participants
0.50  (1.38) -2.44  (2.65)
Week 48 Number Analyzed 0 participants 1 participants
-1.00
Week 56 Number Analyzed 0 participants 1 participants
-1.00
Week 64 Number Analyzed 0 participants 1 participants
-4.00
2.Primary Outcome
Title Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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 Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 (n=33) Number Analyzed 33 participants
-0.82  (1.55)
Week 8 (n=29) Number Analyzed 29 participants
-0.69  (1.28)
Week 16 (n=24) Number Analyzed 24 participants
-0.67  (2.14)
Week 24 (n=21) Number Analyzed 21 participants
-1.19  (1.75)
Week 40 (n=14) Number Analyzed 14 participants
-0.21  (2.86)
Week 48 (n=1) Number Analyzed 1 participants
0.00
Week 56 (n=1) Number Analyzed 1 participants
0.00
Week 64 (n=1) Number Analyzed 1 participants
-3.00
3.Primary Outcome
Title Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (A4091029) Number Analyzed 19 participants 18 participants
-0.68  (2.69) -0.72  (2.08)
Week 4 Number Analyzed 18 participants 17 participants
-1.22  (2.44) -1.24  (1.71)
Week 8 Number Analyzed 15 participants 15 participants
-0.87  (2.17) -0.87  (1.92)
Week 16 Number Analyzed 12 participants 13 participants
-0.67  (2.96) -1.23  (2.68)
Week 24 Number Analyzed 10 participants 12 participants
-1.20  (2.10) -2.17  (1.99)
Week 40 Number Analyzed 6 participants 9 participants
-0.33  (2.07) -2.11  (2.62)
Week 48 Number Analyzed 0 participants 1 participants
-2.0
Week 56 Number Analyzed 0 participants 1 participants
-2.0
Week 64 Number Analyzed 0 participants 1 participants
-5.0
4.Primary Outcome
Title Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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 Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 Number Analyzed 33 participants
-0.82  (1.83)
Week 8 Number Analyzed 29 participants
-0.48  (1.72)
Week 16 Number Analyzed 24 participants
-0.25  (2.92)
Week 24 Number Analyzed 21 participants
-1.14  (2.20)
Week 40 Number Analyzed 14 participants
-0.36  (2.87)
Week 48 Number Analyzed 1 participants
0.00
Week 56 Number Analyzed 1 participants
0.00
Week 64 Number Analyzed 1 participants
-3.00
5.Primary Outcome
Title Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (A4091029) Number Analyzed 19 participants 18 participants
-1.05  (2.04) -1.28  (2.14)
Week 4 Number Analyzed 18 participants 17 participants
-2.28  (1.96) -2.18  (2.07)
Week 8 Number Analyzed 15 participants 15 participants
-1.40  (1.76) -2.60  (1.64)
Week 16 Number Analyzed 12 participants 13 participants
-1.67  (2.53) -3.31  (2.32)
Week 24 Number Analyzed 10 participants 12 participants
-2.50  (1.84) -3.25  (1.82)
Week 40 Number Analyzed 6 participants 9 participants
-1.00  (1.67) -2.67  (2.83)
Week 48 Number Analyzed 0 participants 1 participants
-3.0
Week 56 Number Analyzed 0 participants 1 participants
-3.0
Week 64 Number Analyzed 0 participants 1 participants
-3.0
6.Primary Outcome
Title Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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 Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 Number Analyzed 33 participants
-1.15  (1.46)
Week 8 Number Analyzed 29 participants
-1.00  (1.36)
Week 16 Number Analyzed 24 participants
-1.08  (1.93)
Week 24 Number Analyzed 21 participants
-1.81  (1.60)
Week 40 Number Analyzed 14 participants
-1.00  (2.11)
Week 48 Number Analyzed 1 participants
-1.00
Week 56 Number Analyzed 1 participants
-1.00
Week 64 Number Analyzed 1 participants
-1.00
7.Primary Outcome
Title 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
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (A4091029) Number Analyzed 19 participants 18 participants
-0.68  (2.73) -1.61  (1.85)
Week 4 Number Analyzed 18 participants 17 participants
-1.67  (1.94) -2.24  (2.31)
Week 8 Number Analyzed 15 participants 15 participants
-1.20  (1.82) -2.40  (2.16)
Week 16 Number Analyzed 12 participants 13 participants
-1.08  (2.64) -2.54  (3.04)
Week 24 Number Analyzed 10 participants 12 participants
-1.20  (1.48) -2.75  (2.56)
Week 40 Number Analyzed 6 participants 9 participants
0.00  (1.10) -2.11  (3.76)
Week 48 Number Analyzed 0 participants 1 participants
-2.00
Week 56 Number Analyzed 0 participants 1 participants
-4.00
Week 64 Number Analyzed 0 participants 1 participants
-4.00
8.Primary Outcome
Title Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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 Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 Number Analyzed 33 participants
-0.82  (1.61)
Week 8 Number Analyzed 29 participants
-0.72  (1.62)
Week 16 Number Analyzed 24 participants
-0.67  (2.62)
Week 24 Number Analyzed 21 participants
-0.95  (1.72)
Week 40 Number Analyzed 14 participants
-0.21  (3.49)
Week 48 Number Analyzed 1 participants
-1.00
Week 56 Number Analyzed 1 participants
-3.00
Week 64 Number Analyzed 1 participants
-3.00
9.Primary Outcome
Title 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
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
Time Frame Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (A4091029) Number Analyzed 18 participants 18 participants
-0.81  (2.32) -1.10  (2.11)
Week 4 Number Analyzed 17 participants 17 participants
-2.03  (2.02) -1.26  (1.91)
Week 8 Number Analyzed 14 participants 15 participants
-1.22  (1.49) -1.61  (2.13)
Week 16 Number Analyzed 11 participants 13 participants
-1.05  (2.35) -1.38  (2.56)
Week 24 Number Analyzed 10 participants 12 participants
-1.41  (1.84) -1.94  (1.87)
Week 40 Number Analyzed 6 participants 8 participants
-0.90  (2.04) -2.38  (2.89)
Week 48 Number Analyzed 0 participants 1 participants
-3.00
Week 56 Number Analyzed 0 participants 1 participants
-3.29
Week 64 Number Analyzed 0 participants 1 participants
-5.43
10.Primary Outcome
Title 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
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
Time Frame Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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 Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 Number Analyzed 33 participants
-0.69  (1.33)
Week 8 Number Analyzed 29 participants
-0.79  (1.90)
Week 16 Number Analyzed 24 participants
-0.29  (2.46)
Week 24 Number Analyzed 21 participants
-0.88  (1.77)
Week 40 Number Analyzed 13 participants
-0.56  (2.81)
Week 48 Number Analyzed 1 participants
-1.71
Week 56 Number Analyzed 1 participants
-2.00
Week 64 Number Analyzed 1 participants
-4.14
11.Primary Outcome
Title 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
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with, general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Time Frame Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
General activity: Baseline Number Analyzed 19 participants 18 participants
-0.68  (2.65) -1.39  (2.57)
General activity: Week 4 Number Analyzed 18 participants 17 participants
-1.94  (2.04) -1.76  (2.11)
General activity: Week 8 Number Analyzed 15 participants 15 participants
-1.47  (2.17) -2.27  (2.19)
General activity: Week 16 Number Analyzed 12 participants 13 participants
-1.00  (2.95) -1.31  (3.09)
General activity: Week 24 Number Analyzed 10 participants 12 participants
-1.60  (1.71) -2.17  (2.37)
General activity: Week 40 Number Analyzed 6 participants 9 participants
-0.83  (1.72) -2.78  (3.03)
General activity: Week 48 Number Analyzed 0 participants 1 participants
-3.00
General activity: Week 56 Number Analyzed 0 participants 1 participants
-3.00
General activity: Week 64 Number Analyzed 0 participants 1 participants
-6.00
Mood: Baseline Number Analyzed 19 participants 18 participants
-1.58  (1.98) -0.94  (2.78)
Mood: Week 4 Number Analyzed 18 participants 17 participants
-2.33  (1.78) -1.53  (2.48)
Mood: Week 8 Number Analyzed 15 participants 15 participants
-2.27  (2.43) -1.53  (2.72)
Mood: Week 16 Number Analyzed 12 participants 13 participants
-1.50  (2.97) -1.62  (3.57)
Mood: Week 24 Number Analyzed 10 participants 12 participants
-2.20  (2.90) -1.58  (2.87)
Mood: Week 40 Number Analyzed 6 participants 9 participants
-1.00  (2.97) -2.56  (3.05)
Mood: Week 48 Number Analyzed 0 participants 1 participants
-4.00
Mood: Week 56 Number Analyzed 0 participants 1 participants
-4.00
Mood: Week 64 Number Analyzed 0 participants 1 participants
-7.00
Walking ability: Baseline Number Analyzed 18 participants 18 participants
-0.67  (2.77) -0.17  (2.57)
Walking ability: Week 4 Number Analyzed 17 participants 17 participants
-1.65  (2.57) -0.24  (2.25)
Walking ability: Week 8 Number Analyzed 14 participants 15 participants
-0.86  (2.25) -0.73  (1.83)
Walking ability: Week 16 Number Analyzed 11 participants 13 participants
-1.00  (2.93) -0.23  (1.88)
Walking ability: Week 24 Number Analyzed 10 participants 12 participants
-1.00  (2.75) -0.92  (1.88)
Walking ability: Week 40 Number Analyzed 6 participants 8 participants
-1.50  (2.81) -0.63  (3.07)
Walking ability: Week 48 Number Analyzed 0 participants 1 participants
-3.00
Walking ability: Week 56 Number Analyzed 0 participants 1 participants
-4.00
Walking ability: Week 64 Number Analyzed 0 participants 1 participants
-5.00
Normal work: Baseline Number Analyzed 18 participants 18 participants
-0.28  (2.85) -1.28  (2.61)
Normal work: Week 4 Number Analyzed 17 participants 17 participants
-1.41  (3.43) -1.12  (2.74)
Normal work: Week 8 Number Analyzed 14 participants 15 participants
-0.50  (2.71) -1.93  (2.94)
Normal work: Week 16 Number Analyzed 11 participants 13 participants
-1.00  (2.28) -1.00  (3.29)
Normal work: Week 24 Number Analyzed 10 participants 12 participants
-1.10  (2.33) -1.75  (2.83)
Normal work: Week 40 Number Analyzed 6 participants 8 participants
-0.67  (2.88) -1.88  (4.49)
Normal work: Week 48 Number Analyzed 0 participants 1 participants
1.00
Normal work: Week 56 Number Analyzed 0 participants 1 participants
0.00
Normal work: Week 64 Number Analyzed 0 participants 1 participants
-3.00
Relations with other people: Baseline Number Analyzed 18 participants 18 participants
-0.50  (2.92) -1.28  (2.44)
Relations with other people: Week 4 Number Analyzed 17 participants 17 participants
-2.41  (2.50) -1.41  (2.29)
Relations with other people: Week 8 Number Analyzed 14 participants 15 participants
-1.00  (2.04) -1.47  (2.64)
Relations with other people: Week 16 Number Analyzed 11 participants 13 participants
-1.36  (3.20) -1.31  (2.50)
Relations with other people: Week 24 Number Analyzed 10 participants 12 participants
-1.40  (2.99) -1.92  (2.31)
Relations with other people: Week 40 Number Analyzed 6 participants 9 participants
-1.17  (2.23) -1.89  (3.06)
Relations with other people: Week 48 Number Analyzed 0 participants 1 participants
-3.00
Relations with other people: Week 56 Number Analyzed 0 participants 1 participants
-3.00
Relations with other people: Week 64 Number Analyzed 0 participants 1 participants
-5.00
Sleep: Baseline Number Analyzed 18 participants 18 participants
-1.00  (2.89) -1.00  (2.43)
Sleep: Week 4 Number Analyzed 17 participants 17 participants
-2.18  (2.32) -1.59  (2.53)
Sleep: Week 8 Number Analyzed 14 participants 15 participants
-1.21  (2.01) -1.47  (3.16)
Sleep: Week 16 Number Analyzed 11 participants 13 participants
-1.09  (1.81) -1.85  (3.02)
Sleep: Week 24 Number Analyzed 10 participants 12 participants
-0.60  (1.90) -2.08  (2.75)
Sleep: Week 40 Number Analyzed 6 participants 9 participants
-0.17  (1.83) -3.11  (3.18)
Sleep: Week 48 Number Analyzed 0 participants 1 participants
-5.00
Sleep: Week 56 Number Analyzed 0 participants 1 participants
-5.00
Sleep: Week 64 Number Analyzed 0 participants 1 participants
-5.00
Enjoyment of life: Baseline Number Analyzed 18 participants 18 participants
-1.39  (2.99) -1.67  (2.72)
Enjoyment of life: Week 4 Number Analyzed 17 participants 17 participants
-2.53  (2.92) -1.18  (2.77)
Enjoyment of life: Week 8 Number Analyzed 14 participants 15 participants
-1.71  (2.64) -1.87  (3.38)
Enjoyment of life: Week 16 Number Analyzed 11 participants 13 participants
-1.09  (2.43) -2.38  (3.50)
Enjoyment of life: Week 24 Number Analyzed 10 participants 12 participants
-2.00  (2.36) -3.17  (2.12)
Enjoyment of life: Week 40 Number Analyzed 6 participants 8 participants
-1.00  (3.58) -3.38  (3.46)
Enjoyment of life: Week 48 Number Analyzed 0 participants 1 participants
-4.00
Enjoyment of life: Week 56 Number Analyzed 0 participants 1 participants
-4.00
Enjoyment of life: Week 64 Number Analyzed 0 participants 1 participants
-7.00
12.Primary Outcome
Title Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Hide Description The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Time Frame Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.
Arm/Group Title Tanezumab 10 mg (A4091029)
Hide Arm/Group Description:
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 Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
General activity: Week 4 Number Analyzed 33 participants
-0.85  (1.84)
General activity: Week 8 Number Analyzed 29 participants
-1.10  (2.27)
General activity: Week 16 Number Analyzed 24 participants
0.04  (2.90)
General activity: Week 24 Number Analyzed 21 participants
-0.90  (2.32)
General activity: Week 40 Number Analyzed 14 participants
-0.57  (2.93)
General activity: Week 48 Number Analyzed 1 participants
-1.00
General activity: Week 56 Number Analyzed 1 participants
-1.00
General activity: Week 64 Number Analyzed 1 participants
-4.00
Mood: Week 4 Number Analyzed 33 participants
-0.70  (1.55)
Mood: Week 8 Number Analyzed 29 participants
-0.86  (2.26)
Mood: Week 16 Number Analyzed 24 participants
-0.21  (2.77)
Mood: Week 24 Number Analyzed 21 participants
-0.62  (1.88)
Mood: Week 40 Number Analyzed 14 participants
-0.14  (3.13)
Mood: Week 48 Number Analyzed 1 participants
-2.00
Mood: Week 56 Number Analyzed 1 participants
-2.00
Mood: Week 64 Number Analyzed 1 participants
-5.00
Walking ability: Week 4 ( Number Analyzed 33 participants
-0.61  (1.60)
Walking ability: Week 8 Number Analyzed 29 participants
-0.79  (1.90)
Walking ability: Week 16 Number Analyzed 24 participants
-0.50  (2.11)
Walking ability: Week 24 Number Analyzed 21 participants
-1.05  (2.06)
Walking ability: Week 40 Number Analyzed 13 participants
-1.08  (2.90)
Walking ability: Week 48 Number Analyzed 1 participants
-2.00
Walking ability: Week 56 Number Analyzed 1 participants
-3.00
Walking ability: Week 64 Number Analyzed 1 participants
-4.00
Normal work: Week 4 Number Analyzed 33 participants
-0.42  (2.02)
Normal work: Week 8 Number Analyzed 29 participants
-0.62  (2.41)
Normal work: Week 16 Number Analyzed 24 participants
0.08  (2.78)
Normal work: Week 24 Number Analyzed 21 participants
-0.76  (1.87)
Normal work: Week 40 Number Analyzed 13 participants
-0.46  (3.36)
Normal work: Week 48 Number Analyzed 1 participants
-1.00
Normal work: Week 56 Number Analyzed 1 participants
-2.00
Normal Work: Week 64 Number Analyzed 1 participants
-5.00
Relations with other people: Week 4 Number Analyzed 33 participants
-1.18  (2.05)
Relations with other people: Week 8 Number Analyzed 29 participants
-0.86  (2.43)
Relations with other people: Week 16 Number Analyzed 24 participants
-0.67  (2.46)
Relations with other people: Week 24 Number Analyzed 21 participants
-1.19  (2.09)
Relations with other people: Week 40 Number Analyzed 14 participants
-0.71  (2.70)
Relations with other people: Week 48 Number Analyzed 1 participants
-3.00
Relations with other people: Week 56 Number Analyzed 1 participants
-3.00
Relations with other people: Week 64 Number Analyzed 1 participants
-5.00
Sleep: Week 4 Number Analyzed 33 participants
-0.94  (1.60)
Sleep: Week 8 Number Analyzed 29 participants
-0.76  (2.15)
Sleep: Week 16 Number Analyzed 24 participants
-0.63  (2.73)
Sleep: Week 24 Number Analyzed 21 participants
-0.86  (2.20)
Sleep: Week 40 Number Analyzed 14 participants
-0.71  (2.76)
Sleep: Week 48 Number Analyzed 1 participants
-1.00
Sleep: Week 56 Number Analyzed 1 participants
-1.00
Sleep: Week 64 Number Analyzed 1 participants
-1.00
Enjoyment of life: Week 4 Number Analyzed 33 participants
-0.12  (1.75)
Enjoyment of life: Week 8 Number Analyzed 29 participants
-0.55  (2.57)
Enjoyment of life: Week 16 Number Analyzed 24 participants
-0.17  (3.12)
Enjoyment of life: Week 24 Number Analyzed 21 participants
-0.81  (2.40)
Enjoyment of life: Week 40 Number Analyzed 13 participants
-0.08  (3.75)
Enjoyment of life: Week 48 Number Analyzed 1 participants
-2.00
Enjoyment of life: Week 56 Number Analyzed 1 participants
-2.00
Enjoyment of life: Week 64 Number Analyzed 1 participants
-5.00
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Tanezumab 10 mg (A4091029)
Hide Arm/Group Description 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.
All-Cause Mortality
Tanezumab 10 mg (A4091029)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Tanezumab 10 mg (A4091029)
Affected / at Risk (%)
Total   23/41 (56.10%) 
Blood and lymphatic system disorders   
Anaemia * 1  4/41 (9.76%) 
Aplastic anaemia * 1  1/41 (2.44%) 
Disseminated intravascular coagulation * 1  1/41 (2.44%) 
Thrombocytopenia * 1  1/41 (2.44%) 
Cardiac disorders   
Cardiovascular insufficiency * 1  1/41 (2.44%) 
General disorders   
Disease progression * 1  3/41 (7.32%) 
Hepatobiliary disorders   
Hepatorenal failure * 1  1/41 (2.44%) 
Infections and infestations   
Bronchopneumonia * 1  1/41 (2.44%) 
Pneumonia * 1  1/41 (2.44%) 
Metabolism and nutrition disorders   
Hypercalcaemia * 1  1/41 (2.44%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness * 1  1/41 (2.44%) 
Pathological fracture * 1  2/41 (4.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer * 1  1/41 (2.44%) 
Malignant neoplasm progression * 1  1/41 (2.44%) 
Meningioma * 1  1/41 (2.44%) 
Metastatic neoplasm * 1  2/41 (4.88%) 
Multiple myeloma * 1  1/41 (2.44%) 
Prostate cancer * 1  3/41 (7.32%) 
Prostate cancer metastatic * 1  2/41 (4.88%) 
Renal cancer * 1  1/41 (2.44%) 
Nervous system disorders   
Cerebral infarction * 1  1/41 (2.44%) 
Renal and urinary disorders   
Renal failure acute * 1  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/41 (2.44%) 
Pulmonary embolism * 1  1/41 (2.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tanezumab 10 mg (A4091029)
Affected / at Risk (%)
Total   18/41 (43.90%) 
Gastrointestinal disorders   
Constipation * 1  3/41 (7.32%) 
Nausea * 1  8/41 (19.51%) 
Vomiting * 1  4/41 (9.76%) 
General disorders   
Asthenia * 1  6/41 (14.63%) 
Oedema peripheral * 1  5/41 (12.20%) 
Pyrexia * 1  5/41 (12.20%) 
Investigations   
Weight decreased * 1  3/41 (7.32%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  3/41 (7.32%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  3/41 (7.32%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/41 (7.32%) 
Dyspnoea * 1  5/41 (12.20%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00830180    
Other Study ID Numbers: A4091029
2008-005182-66 ( EudraCT Number )
CANCER PAIN OL EXTENSION ( Other Identifier: Alias Study Number )
First Submitted: January 26, 2009
First Posted: January 27, 2009
Results First Submitted: January 11, 2021
Results First Posted: February 2, 2021
Last Update Posted: April 5, 2021