TriangleNCT04269200 · OUTCOME
Change From Baseline in Physical Functioning Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients 30 (EORTC QLQ-C30)
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
- At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.
What was measured
To determine effects on symptoms, functioning, and overall health related quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
Analysis population: FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline physical functioning score available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.
Groups in this outcome
Global Cohort - SoC
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
Global Cohort - SoC + Durvalumab
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
Global Cohort - SoC + Durvalumab + Olaparib
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
| Group | Source count |
|---|---|
| Global Cohort - SoC | 187 |
| Global Cohort - SoC + Durvalumab | 190 |
| Global Cohort - SoC + Durvalumab + Olaparib | 199 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Global Cohort - SoC | -5.3 | 1.03 | Not reported | Not reported | Not reported |
| Global Cohort - SoC + Durvalumab | -3.6 | 1.02 | Not reported | Not reported | Not reported |
| Global Cohort - SoC + Durvalumab + Olaparib | -5.9 | 0.98 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.5
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value Comment
- Descriptive analysis only.
- param Type
- Least-squares Mean Difference
- param Value
- 1.7
- statistical Comment
- Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
- statistical Method
- Mixed model for repeated measures
- ci Lower Limit
- -3.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.2
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value Comment
- Descriptive analysis only.
- param Type
- Least-squares Mean Difference
- param Value
- -0.6
- statistical Comment
- Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
- statistical Method
- Mixed model for repeated measures
Complete source fields
- analyses
- ci Lower Limit
- -1.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.5
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value Comment
- Descriptive analysis only.
- param Type
- Least-squares Mean Difference
- param Value
- 1.7
- statistical Comment
- Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
- statistical Method
- Mixed model for repeated measures
- ci Lower Limit
- -3.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.2
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value Comment
- Descriptive analysis only.
- param Type
- Least-squares Mean Difference
- param Value
- -0.6
- statistical Comment
- Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
- statistical Method
- Mixed model for repeated measures
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.03
- value
- -5.3
- group Id
- OG001
- spread
- 1.02
- value
- -3.6
- group Id
- OG002
- spread
- 0.98
- value
- -5.9
- denoms
- counts
- group Id
- OG000
- value
- 187
- group Id
- OG001
- value
- 190
- group Id
- OG002
- value
- 199
- units
- Participants
- description
- To determine effects on symptoms, functioning, and overall health related quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
- dispersion Type
- Standard Error
- groups
- description
- Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
- id
- OG000
- title
- Global Cohort - SoC
- description
- Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
- id
- OG001
- title
- Global Cohort - SoC + Durvalumab
- description
- Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
- id
- OG002
- title
- Global Cohort - SoC + Durvalumab + Olaparib
- param Type
- LEAST_SQUARES_MEAN
- population Description
- FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline physical functioning score available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.
- reporting Status
- POSTED
- time Frame
- At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.
- title
- Change From Baseline in Physical Functioning Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients 30 (EORTC QLQ-C30)
- type
- SECONDARY
- unit Of Measure
- Score on a scale
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Preserved source evidence · Not medical advice