TriangleNCT04145349 · OUTCOME
Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 80% Confidence Interval
- Time frame
- Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 23 Months)
What was measured
DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence .Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Analysis population: All randomized participants who received at least one dose of study drug and who had CR or PR responses (including the censored participants). Number of participants censored in Ramucirumab + Cyclophosphamide + Vinorelbine = 0, Cyclophosphamide + Vinorelbine = 1.
Groups in this outcome
Ramucirumab + Cyclophosphamide + Vinorelbine
Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Cyclophosphamide + Vinorelbine
Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
| Group | Source count |
|---|---|
| Ramucirumab + Cyclophosphamide + Vinorelbine | 2 |
| Cyclophosphamide + Vinorelbine | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Cyclophosphamide + Vinorelbine | 9.55 | Not reported | 4.89 | NA | There were not enough events to estimate the upper limit of the 80% confidence interval. |
| Cyclophosphamide + Vinorelbine | NA | Not reported | NA | NA | Estimation of the median and the 80% confidence interval limits (lower and upper) was not possible as the participant did not achieve the event and was censored. |
Complete source fields
- classes
- categories
- measurements
- comment
- There were not enough events to estimate the upper limit of the 80% confidence interval.
- group Id
- OG000
- lower Limit
- 4.89
- upper Limit
- NA
- value
- 9.55
- comment
- Estimation of the median and the 80% confidence interval limits (lower and upper) was not possible as the participant did not achieve the event and was censored.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence .Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
- dispersion Type
- 80% Confidence Interval
- groups
- description
- Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
- id
- OG000
- title
- Ramucirumab + Cyclophosphamide + Vinorelbine
- description
- Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
- id
- OG001
- title
- Cyclophosphamide + Vinorelbine
- param Type
- MEDIAN
- population Description
- All randomized participants who received at least one dose of study drug and who had CR or PR responses (including the censored participants). Number of participants censored in Ramucirumab + Cyclophosphamide + Vinorelbine = 0, Cyclophosphamide + Vinorelbine = 1.
- reporting Status
- POSTED
- time Frame
- Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 23 Months)
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice