TriangleNCT04195750 · OUTCOME
Duration of Response (DOR) Per RECIST 1.1 as Assessed by 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 49 months
What was measured
For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR as assessed by blinded independent central review is presented here. The Median DOR was analyzed by the Kaplan-Meier method for censored data.
Analysis population: Per protocol, the analysis population consisted of all randomized participants based on the treatment group to which they were randomized, and who experienced a confirmed complete response (CR) or partial response (PR). 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 | 85 |
| Everolimus | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belzutifan | 19.3 | Not reported | 14.0 | 28.6 | Not reported |
| Everolimus | 13.7 | Not reported | 5.6 | 20.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.0
- upper Limit
- 28.6
- value
- 19.3
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 20.5
- value
- 13.7
- denoms
- counts
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR as assessed by blinded independent central review is presented here. The Median DOR was analyzed by the 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 based on the treatment group to which they were randomized, and who experienced a confirmed complete response (CR) or partial response (PR). 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 49 months
- title
- Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice