TriangleNCT02855944 · OUTCOME
Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline to the end of Cycle 6, or up to approximately 6 months
What was measured
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed.
Analysis population: Efficacy population - All randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation, and with a baseline value and at least one post-baseline value for the EORTC QLQ-C30 Global Health Status score during the first 6 cycles.
Groups in this outcome
Rucaparib
Patients randomized to the rucaparib arm.
Chemotherapy
Patients randomized to the chemotherapy arm.
| Group | Source count |
|---|---|
| Rucaparib | 197 |
| Chemotherapy | 91 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rucaparib | 0.5 | 0.55 | Not reported | Not reported | Not reported |
| Chemotherapy | 0.3 | 0.86 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.55
- value
- 0.5
- group Id
- OG001
- spread
- 0.86
- value
- 0.3
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 91
- units
- Participants
- description
- EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed.
- dispersion Type
- Standard Error
- groups
- description
- Patients randomized to the rucaparib arm.
- id
- OG000
- title
- Rucaparib
- description
- Patients randomized to the chemotherapy arm.
- id
- OG001
- title
- Chemotherapy
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Efficacy population - All randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation, and with a baseline value and at least one post-baseline value for the EORTC QLQ-C30 Global Health Status score during the first 6 cycles.
- reporting Status
- POSTED
- time Frame
- Baseline to the end of Cycle 6, or up to approximately 6 months
- title
- Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice