NCT04145349 · OUTCOME
Complete Response (CR) : Percentage of Participants Who Achieved a CR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 80% Confidence Interval
- Time frame
- Randomization until measured progressive disease (Up To 23 Months)
What was measured
CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to \<10 mm.Tumor marker results were required to have normalized.
Analysis population: All randomized participants who received at least one dose of study drug.
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 | 20 |
| Cyclophosphamide + Vinorelbine | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Cyclophosphamide + Vinorelbine | 5.0 | Not reported | 0.5 | 18.1 | Not reported |
| Cyclophosphamide + Vinorelbine | 0 | Not reported | 0.0 | 20.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 18.1
- value
- 5.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 20.6
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to \<10 mm.Tumor marker results were required to have normalized.
- 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
- NUMBER
- population Description
- All randomized participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Randomization until measured progressive disease (Up To 23 Months)
- title
- Complete Response (CR) : Percentage of Participants Who Achieved a CR
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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