TriangleNCT04195750 · OUTCOME
TTD in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 39 months
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. TTD was defined as the time to first onset of a ≥3-point decrease in symptom score from baseline with confirmation by the subsequent visit of a ≥3-point deterioration from baseline under right-censoring rule. If the first deterioration is at the last PRO assessment timepoint at the time of analysis, then no confirmation is required. A longer TTD indicates a better outcome. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
Analysis population: Per protocol, the analysis population consisted of all randomized participants who have at least one assessment available for FKSI-DRS and have received at least one dose of the study intervention; and had data available for this TTD 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 | 352 |
| Everolimus | 334 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belzutifan | NA | Not reported | 21.26 | NA | NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event. |
| Everolimus | 11.99 | Not reported | 5.55 | 15.38 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.69
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.53
- statistical Comment
- Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.69
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.53
- statistical Comment
- Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
- group Id
- OG000
- lower Limit
- 21.26
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 5.55
- upper Limit
- 15.38
- value
- 11.99
- denoms
- counts
- group Id
- OG000
- value
- 352
- group Id
- OG001
- value
- 334
- 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. TTD was defined as the time to first onset of a ≥3-point decrease in symptom score from baseline with confirmation by the subsequent visit of a ≥3-point deterioration from baseline under right-censoring rule. If the first deterioration is at the last PRO assessment timepoint at the time of analysis, then no confirmation is required. A longer TTD indicates a better outcome. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.
- 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
- MEDIAN
- population Description
- Per protocol, the analysis population consisted of all randomized participants who have at least one assessment available for FKSI-DRS and have received at least one dose of the study intervention; and had data available for this TTD 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
- Up to approximately 39 months
- title
- TTD in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice