TriangleNCT04195750 · OUTCOME
Change From Baseline to Week 17 in Disease Symptoms Using the FKSI-DRS Items 1-9 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 FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. The change from baseline to Week 17 in Disease Symptoms using the FKSI-DRS Items 1-9 score was calculated based on a constrained longitudinal data analysis (cLDA) model with the PRO 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 FKSI-DRS at baseline or post-baseline up to Week 17; and had data available for this change from baseline in disease symptoms outcome using FKSI-DRS. 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 | -0.17 | Not reported | -0.70 | 0.36 | Not reported |
| Everolimus | -1.62 | Not reported | -2.17 | -1.06 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.19
- estimate Comment
- Based on a cLDA model with the PRO 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
- 0.0002
- param Type
- Difference in LS Means
- param Value
- 1.45
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.19
- estimate Comment
- Based on a cLDA model with the PRO 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
- 0.0002
- param Type
- Difference in LS Means
- param Value
- 1.45
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.70
- upper Limit
- 0.36
- value
- -0.17
- group Id
- OG001
- lower Limit
- -2.17
- upper Limit
- -1.06
- value
- -1.62
- denoms
- counts
- group Id
- OG000
- value
- 363
- group Id
- OG001
- value
- 353
- units
- Participants
- description
- The FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. The change from baseline to Week 17 in Disease Symptoms using the FKSI-DRS Items 1-9 score was calculated based on a constrained longitudinal data analysis (cLDA) model with the PRO 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 FKSI-DRS at baseline or post-baseline up to Week 17; and had data available for this change from baseline in disease symptoms outcome using FKSI-DRS. 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 Disease Symptoms Using the FKSI-DRS Items 1-9 Score
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
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Preserved source evidence · Not medical advice