NCT02609828 · OUTCOME
Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24
Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy · Source last updated 2023-02-16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, Weeks 2, 4, 8, 16 and 24
What was measured
Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores:1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition.
Analysis population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. Here, ''number analyzed'' signifies participants evaluable at specified time points.
Groups in this outcome
Placebo
Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
Tanezumab 10 mg
Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.
Tanezumab 10/20 mg
Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks.
Tanezumab 20 mg
Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10 mg | 9 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 72 |
|---|
Reported measurements
Week 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10 mg | 9 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 72 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10/20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 20 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10 mg | 9 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 72 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10/20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 20 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10 mg | 9 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 72 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10/20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 20 mg | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 16
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10 mg | 6 |
|---|
| Tanezumab 10/20 mg | 0 |
|---|
| Tanezumab 20 mg | 72 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 20 mg | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10 mg | 6 |
|---|
| Tanezumab 10/20 mg | 0 |
|---|
| Tanezumab 20 mg | 72 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tanezumab 20 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 0.09
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.69
- group Description
- Week 2: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2033
- param Type
- Odds Ratio (OR)
- param Value
- 0.38
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.41
- group Description
- Week 4: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7627
- param Type
- Odds Ratio (OR)
- param Value
- 1.18
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.43
- group Description
- Week 8: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.6894
- param Type
- Odds Ratio (OR)
- param Value
- 1.23
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.83
- group Description
- Week 16: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5905
- param Type
- Odds Ratio (OR)
- param Value
- 1.34
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.35
- group Description
- Week 24: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8354
- param Type
- Odds Ratio (OR)
- param Value
- 1.12
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 0.09
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.69
- group Description
- Week 2: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2033
- param Type
- Odds Ratio (OR)
- param Value
- 0.38
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.41
- group Description
- Week 4: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7627
- param Type
- Odds Ratio (OR)
- param Value
- 1.18
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.43
- group Description
- Week 8: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.6894
- param Type
- Odds Ratio (OR)
- param Value
- 1.23
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.83
- group Description
- Week 16: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5905
- param Type
- Odds Ratio (OR)
- param Value
- 1.34
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.35
- group Description
- Week 24: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8354
- param Type
- Odds Ratio (OR)
- param Value
- 1.12
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 72
- units
- Participants
- title
- Week 2
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 72
- units
- Participants
- title
- Week 4
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 72
- units
- Participants
- title
- Week 8
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 2
- group Id
- OG003
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 72
- units
- Participants
- title
- Week 16
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 1
- group Id
- OG003
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 72
- units
- Participants
- title
- Week 24
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 72
- units
- Participants
- description
- Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores:1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition.
- groups
- description
- Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
- id
- OG000
- title
- Placebo
- description
- Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.
- id
- OG001
- title
- Tanezumab 10 mg
- description
- Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks.
- id
- OG002
- title
- Tanezumab 10/20 mg
- description
- Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
- id
- OG003
- title
- Tanezumab 20 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. Here, ''number analyzed'' signifies participants evaluable at specified time points.
- reporting Status
- POSTED
- time Frame
- Baseline, Weeks 2, 4, 8, 16 and 24
- title
- Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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