TriangleNCT02184195 · OUTCOME
Time From Randomisation to Second Progression (PFS2)
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 efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.
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) | 16.9 | Not reported | 8.21 | 23.85 | Not reported |
| Placebo | 9.3 | Not reported | 8.15 | 13.54 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.426
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.020
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0613
- param Type
- Hazard Ratio (HR)
- param Value
- 0.659
- statistical Method
- Log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.426
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.020
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0613
- param Type
- Hazard Ratio (HR)
- param Value
- 0.659
- statistical Method
- Log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.21
- upper Limit
- 23.85
- value
- 16.9
- group Id
- OG001
- lower Limit
- 8.15
- upper Limit
- 13.54
- value
- 9.3
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.
- 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
- Time From Randomisation to Second Progression (PFS2)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice