TriangleNCT04195750 · OUTCOME
Change From Baseline to Week 17 in the HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score
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
- 95% Confidence Interval
- Time frame
- Baseline (Day 1) and week 17
What was measured
The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a higher score indicating a better overall outcome. Change from baseline to Week 17 in EORTC QLQ-C30 Items 29 and 30 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.
Analysis population: Per protocol, the analysis population consisted of all randomized participants who have received at least one dose of the study intervention and had assessments available for EORTC QLQ-C30 at baseline or post-baseline up to Week 17; and had data available for this change from baseline in HRQoL outcome using EORTC QLQ-C30. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures.
Groups in this outcome
Belzutifan
Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.
Everolimus
Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.
| Group | Source count |
|---|---|
| Belzutifan | 363 |
| Everolimus | 353 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belzutifan | 0.28 | Not reported | -1.98 | 2.53 | Not reported |
| Everolimus | -6.11 | Not reported | -8.51 | -3.70 | Not reported |
Source statistical analyses
- ci Lower Limit
- 3.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 9.55
- estimate Comment
- Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Difference in Least Squares (LS) Means
- param Value
- 6.38
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- ci Lower Limit
- 3.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 9.55
- estimate Comment
- Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Difference in Least Squares (LS) Means
- param Value
- 6.38
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.98
- upper Limit
- 2.53
- value
- 0.28
- group Id
- OG001
- lower Limit
- -8.51
- upper Limit
- -3.70
- value
- -6.11
- denoms
- counts
- group Id
- OG000
- value
- 363
- group Id
- OG001
- value
- 353
- units
- Participants
- description
- The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a higher score indicating a better overall outcome. Change from baseline to Week 17 in EORTC QLQ-C30 Items 29 and 30 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.
- id
- OG000
- title
- Belzutifan
- description
- Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.
- id
- OG001
- title
- Everolimus
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Per protocol, the analysis population consisted of all randomized participants who have received at least one dose of the study intervention and had assessments available for EORTC QLQ-C30 at baseline or post-baseline up to Week 17; and had data available for this change from baseline in HRQoL outcome using EORTC QLQ-C30. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and week 17
- title
- Change From Baseline to Week 17 in the HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
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Preserved source evidence · Not medical advice