TriangleNCT02184195 · OUTCOME
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)
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
- Up to 4 years
What was measured
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.
Analysis population: Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
Groups in this outcome
Olaparib 300 mg Twice Daily (bd)
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Placebo
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
| Group | Source count |
|---|---|
| Olaparib 300 mg Twice Daily (bd) | 92 |
| Placebo | 62 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Olaparib 300 mg Twice Daily (bd) | 7.4 | Not reported | 4.14 | 11.01 | Not reported |
| Placebo | 3.8 | Not reported | 3.52 | 4.86 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.346
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.815
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0038
- param Type
- Hazard Ratio (HR)
- param Value
- 0.531
- statistical Method
- Log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.346
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.815
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0038
- param Type
- Hazard Ratio (HR)
- param Value
- 0.531
- statistical Method
- Log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.14
- upper Limit
- 11.01
- value
- 7.4
- group Id
- OG001
- lower Limit
- 3.52
- upper Limit
- 4.86
- value
- 3.8
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- id
- OG000
- title
- Olaparib 300 mg Twice Daily (bd)
- description
- Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
- reporting Status
- POSTED
- time Frame
- Up to 4 years
- title
- Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice