NCT02609828 · OUTCOME
Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) 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
- LEAST_SQUARES_MEAN
- Unit
- Units on a scale
- Interval / dispersion
- Standard Error
- 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. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''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 10mg
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 10mg | 9 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 71 |
|---|
Reported measurements
Change at Week 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10mg | 9 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 71 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -0.39 | 0.11 | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were 0, 0, -3, 0, -2, 1, 0, -1 and -1. |
|---|
| Tanezumab 10/20 mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 1. |
|---|
| Tanezumab 20 mg | -0.43 | 0.12 | Not reported | Not reported | Not reported |
|---|
Change at Week 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10mg | 9 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 71 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -0.36 | 0.14 | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were 0, 1, 0, 0, -3, 1, 0, 0 and -1. |
|---|
| Tanezumab 10/20 mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 0. |
|---|
| Tanezumab 20 mg | -0.66 | 0.14 | Not reported | Not reported | Not reported |
|---|
Change at Week 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10mg | 9 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 71 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -0.23 | 0.16 | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -1, 0, -1, 0, -3, 1, 0, -1 and -1. |
|---|
| Tanezumab 10/20 mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 1. |
|---|
| Tanezumab 20 mg | -0.56 | 0.17 | Not reported | Not reported | Not reported |
|---|
Change at Week 16
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10mg | 6 |
|---|
| Tanezumab 10/20 mg | 0 |
|---|
| Tanezumab 20 mg | 71 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -0.16 | 0.16 | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -2, 0, -3, 1, 0 and -1. |
|---|
| Tanezumab 20 mg | -0.32 | 0.17 | Not reported | Not reported | Not reported |
|---|
Change at Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| Tanezumab 10mg | 6 |
|---|
| Tanezumab 10/20 mg | 0 |
|---|
| Tanezumab 20 mg | 71 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -0.19 | 0.18 | Not reported | Not reported | Not reported |
|---|
| Tanezumab 10mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -1, 0, -3, 1, 2 and -1. |
|---|
| Tanezumab 20 mg | -0.29 | 0.17 | 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
- -0.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.19
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.12
- group Description
- Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7045
- param Type
- Difference in LS mean
- param Value
- -0.04
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.01
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.14
- group Description
- Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0402
- param Type
- Difference in LS mean
- param Value
- -0.30
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.02
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.17
- group Description
- Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0637
- param Type
- Difference in LS mean
- param Value
- -0.33
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.20
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.18
- group Description
- Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3804
- param Type
- Difference in LS mean
- param Value
- -0.16
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.27
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.18
- group Description
- Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5894
- param Type
- Difference in LS mean
- param Value
- -0.10
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -0.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.19
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.12
- group Description
- Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7045
- param Type
- Difference in LS mean
- param Value
- -0.04
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.01
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.14
- group Description
- Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0402
- param Type
- Difference in LS mean
- param Value
- -0.30
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.02
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.17
- group Description
- Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0637
- param Type
- Difference in LS mean
- param Value
- -0.33
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.20
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.18
- group Description
- Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3804
- param Type
- Difference in LS mean
- param Value
- -0.16
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.27
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.18
- group Description
- Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5894
- param Type
- Difference in LS mean
- param Value
- -0.10
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.11
- value
- -0.39
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were 0, 0, -3, 0, -2, 1, 0, -1 and -1.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 1.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 0.12
- value
- -0.43
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 71
- units
- Participants
- title
- Change at Week 2
- categories
- measurements
- group Id
- OG000
- spread
- 0.14
- value
- -0.36
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were 0, 1, 0, 0, -3, 1, 0, 0 and -1.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 0.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 0.14
- value
- -0.66
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 71
- units
- Participants
- title
- Change at Week 4
- categories
- measurements
- group Id
- OG000
- spread
- 0.16
- value
- -0.23
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -1, 0, -1, 0, -3, 1, 0, -1 and -1.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 1.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 0.17
- value
- -0.56
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 71
- units
- Participants
- title
- Change at Week 8
- categories
- measurements
- group Id
- OG000
- spread
- 0.16
- value
- -0.16
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -2, 0, -3, 1, 0 and -1.
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 0.17
- value
- -0.32
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 71
- units
- Participants
- title
- Change at Week 16
- categories
- measurements
- group Id
- OG000
- spread
- 0.18
- value
- -0.19
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -1, 0, -3, 1, 2 and -1.
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 0.17
- value
- -0.29
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 71
- units
- Participants
- title
- Change at Week 24
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 71
- 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.
- dispersion Type
- Standard Error
- 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 10mg
- 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
- LEAST_SQUARES_MEAN
- 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. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.
- reporting Status
- POSTED
- time Frame
- Baseline, Weeks 2, 4, 8, 16 and 24
- title
- Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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