TriangleNCT04195750 · OUTCOME
Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
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
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review is presented here.
Analysis population: Per protocol, the analysis population consisted of all randomized participants based on the treatment group to which they were randomized. 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 | 374 |
| Everolimus | 372 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belzutifan | 5.6 | Not reported | 3.8 | 6.5 | Not reported |
| Everolimus | 5.6 | Not reported | 4.8 | 5.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.88
- 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
- SUPERIORITY
- p Value
- 0.00031
- param Type
- Hazard Ratio (HR)
- param Value
- 0.74
- statistical Comment
- One-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
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.88
- 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
- SUPERIORITY
- p Value
- 0.00031
- param Type
- Hazard Ratio (HR)
- param Value
- 0.74
- statistical Comment
- One-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
- group Id
- OG000
- lower Limit
- 3.8
- upper Limit
- 6.5
- value
- 5.6
- group Id
- OG001
- lower Limit
- 4.8
- upper Limit
- 5.8
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 374
- group Id
- OG001
- value
- 372
- units
- Participants
- description
- PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review is presented here.
- 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 based on the treatment group to which they were randomized. 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
- Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice