TriangleNCT01844986 · OUTCOME
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported
What was measured
To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
Analysis population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) with a baseline and post baseline TOI scores available.
Groups in this outcome
Olaparib 300mg Tablets (Global Cohort)
Taken orally twice daily
Placebo Tablets (Global Cohort)
Taken orally twice daily
| Group | Source count |
|---|---|
| Olaparib 300mg Tablets (Global Cohort) | 260 |
| Placebo Tablets (Global Cohort) | 131 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Olaparib 300mg Tablets (Global Cohort) | 0.30 | Not reported | -0.717 | 1.318 | Not reported |
| Placebo Tablets (Global Cohort) | 3.30 | Not reported | 1.839 | 4.758 | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.779
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.216
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0010
- param Type
- Mean Difference (Final Values)
- param Value
- -3.00
- statistical Comment
- Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -4.779
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.216
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0010
- param Type
- Mean Difference (Final Values)
- param Value
- -3.00
- statistical Comment
- Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.717
- upper Limit
- 1.318
- value
- 0.30
- group Id
- OG001
- lower Limit
- 1.839
- upper Limit
- 4.758
- value
- 3.30
- denoms
- counts
- group Id
- OG000
- value
- 260
- group Id
- OG001
- value
- 131
- units
- Participants
- description
- To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
- 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)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) with a baseline and post baseline TOI scores available.
- reporting Status
- POSTED
- time Frame
- Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported
- title
- Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice