TriangleNCT02184195 · OUTCOME
Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 4 years
What was measured
To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.
Analysis population: All randomised patients with measurable disease at baseline.
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) | 72 |
| Placebo | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Olaparib 300 mg Twice Daily (bd) | 22 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 11 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.668
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.610
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3273
- param Type
- Odds Ratio (OR)
- param Value
- 1.520
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 0.668
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.610
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3273
- param Type
- Odds Ratio (OR)
- param Value
- 1.520
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 72
- group Id
- OG001
- value
- 49
- units
- Participants
- description
- To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- All randomised patients with measurable disease at baseline.
- reporting Status
- POSTED
- time Frame
- Up to 4 years
- title
- Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice