TriangleNCT01995513 · OUTCOME
Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
What was measured
Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to \<10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: \>= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
Analysis population: ITT population (with measurable disease at screening) included all participants randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.
Groups in this outcome
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
| Group | Source count |
|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 38 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 40 |
Reported measurements
CR + PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 0.0 | Not reported | 0.00 | 9.25 | Not reported |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 5.0 | Not reported | 0.61 | 16.92 | Not reported |
CR + PR + SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 68.4 | Not reported | 51.35 | 82.50 | Not reported |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 57.5 | Not reported | 40.89 | 72.96 | Not reported |
Source statistical analyses
- ci Lower Limit
- -11.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.75
- estimate Comment
- Difference in objective response rate was based upon standard normal approximation.
- group Description
- This analysis is reported for participants with CR+PR.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1653
- p Value Comment
- P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Difference in Objective Response Rate
- param Value
- -5.00
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -10.37
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 32.21
- estimate Comment
- Difference in objective response rate was based upon standard normal approximation.
- group Description
- This analysis is reported for participants with CR+PR+SD.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3216
- p Value Comment
- P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Difference in Objective Response Rate
- param Value
- 10.92
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -11.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.75
- estimate Comment
- Difference in objective response rate was based upon standard normal approximation.
- group Description
- This analysis is reported for participants with CR+PR.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1653
- p Value Comment
- P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Difference in Objective Response Rate
- param Value
- -5.00
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -10.37
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 32.21
- estimate Comment
- Difference in objective response rate was based upon standard normal approximation.
- group Description
- This analysis is reported for participants with CR+PR+SD.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3216
- p Value Comment
- P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Difference in Objective Response Rate
- param Value
- 10.92
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 9.25
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.61
- upper Limit
- 16.92
- value
- 5.0
- title
- CR + PR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.35
- upper Limit
- 82.50
- value
- 68.4
- group Id
- OG001
- lower Limit
- 40.89
- upper Limit
- 72.96
- value
- 57.5
- title
- CR + PR + SD
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to \<10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: \>= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
- id
- OG000
- title
- Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
- description
- Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
- id
- OG001
- title
- Placebo+Abiraterone 1000mg+ Prednisone 10mg
- param Type
- NUMBER
- population Description
- ITT population (with measurable disease at screening) included all participants randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice