TriangleNCT01844986 · OUTCOME
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
What was measured
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of overall survival (OS). Reports results of a pre-specified interim analysis; results for final OS analysis (235 OS events) anticipated 2029.
Analysis population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).
Groups in this outcome
Olaparib 300mg Tablets (Global Cohort)
Taken orally twice daily
Placebo Tablets (Global Cohort)
Taken orally twice daily
Olaparib 300mg Tablets (China Cohort)
Taken orally twice daily
Placebo Tablets (China Cohort)
Taken orally twice daily
| Group | Source count |
|---|---|
| Olaparib 300mg Tablets (Global Cohort) | 260 |
| Placebo Tablets (Global Cohort) | 131 |
| Olaparib 300mg Tablets (China Cohort) | 44 |
| Placebo Tablets (China Cohort) | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Olaparib 300mg Tablets (Global Cohort) | NA | Not reported | NA | NA | Insufficient OS events to estimate median, lower and upper confidence limit. |
| Placebo Tablets (Global Cohort) | NA | Not reported | NA | NA | Insufficient OS events to estimate median, lower and upper confidence limit. |
| Olaparib 300mg Tablets (China Cohort) | NA | Not reported | NA | NA | Insufficient OS events to estimate median, lower and upper confidence limit. |
| Placebo Tablets (China Cohort) | NA | Not reported | NA | NA | Insufficient OS events to estimate median, lower and upper confidence limit. |
Source statistical analyses
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.53
- estimate Comment
- A hazard ratio \< 1 favours olaparib
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8903
- p Value Comment
- Determined using a log-rank test stratified by response to previous platinum chemotherapy
- param Type
- Hazard Ratio (HR)
- param Value
- 0.95
- statistical Comment
- Model includes a factor for response to previous platinum chemotherapy
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.28
- estimate Comment
- A hazard ratio \< 1 favours olaparib
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value Comment
- Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.77
- statistical Comment
- Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.53
- estimate Comment
- A hazard ratio \< 1 favours olaparib
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8903
- p Value Comment
- Determined using a log-rank test stratified by response to previous platinum chemotherapy
- param Type
- Hazard Ratio (HR)
- param Value
- 0.95
- statistical Comment
- Model includes a factor for response to previous platinum chemotherapy
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.28
- estimate Comment
- A hazard ratio \< 1 favours olaparib
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value Comment
- Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.77
- statistical Comment
- Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- comment
- Insufficient OS events to estimate median, lower and upper confidence limit.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Insufficient OS events to estimate median, lower and upper confidence limit.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Insufficient OS events to estimate median, lower and upper confidence limit.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Insufficient OS events to estimate median, lower and upper confidence limit.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 260
- group Id
- OG001
- value
- 131
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 20
- units
- Participants
- description
- To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of overall survival (OS). Reports results of a pre-specified interim analysis; results for final OS analysis (235 OS events) anticipated 2029.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Taken orally twice daily
- id
- OG000
- title
- Olaparib 300mg Tablets (Global Cohort)
- description
- Taken orally twice daily
- id
- OG001
- title
- Placebo Tablets (Global Cohort)
- description
- Taken orally twice daily
- id
- OG002
- title
- Olaparib 300mg Tablets (China Cohort)
- description
- Taken orally twice daily
- id
- OG003
- title
- Placebo Tablets (China Cohort)
- param Type
- MEDIAN
- population Description
- Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).
- reporting Status
- POSTED
- time Frame
- Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
- title
- Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice