TriangleNCT02184195 · OUTCOME
Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Unit on scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From baseline up to 6 months
What was measured
To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100. A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful. bd twice daily.
Analysis population: Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.
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) | 84 |
| Placebo | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Olaparib 300 mg Twice Daily (bd) | -1.03 | Not reported | -3.826 | 1.759 | Not reported |
| Placebo | 1.18 | Not reported | -2.585 | 4.939 | Not reported |
Source statistical analyses
- ci Lower Limit
- -6.917
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.496
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.355
- param Type
- Mean Difference (Final Values)
- param Value
- -2.21
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -6.917
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.496
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.355
- param Type
- Mean Difference (Final Values)
- param Value
- -2.21
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.826
- upper Limit
- 1.759
- value
- -1.03
- group Id
- OG001
- lower Limit
- -2.585
- upper Limit
- 4.939
- value
- 1.18
- denoms
- counts
- group Id
- OG000
- value
- 84
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100. A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful. bd twice daily.
- 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
- MEAN
- population Description
- Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.
- reporting Status
- POSTED
- time Frame
- From baseline up to 6 months
- title
- Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
- type
- SECONDARY
- unit Of Measure
- Unit on scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice