TriangleNCT02426125 · OUTCOME
Percentage of Participants With an Objective Response Rate (ORR)
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
- 95% Confidence Interval
- Time frame
- Randomization to Disease Progression (Up to 29.7 Months)
What was measured
ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 millimeter (mm). Tumor-marker results must have normalized. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1.
Analysis population: All randomized participants.
Groups in this outcome
Ramucirumab + Docetaxel
Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Placebo + Docetaxel
Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
| Group | Source count |
|---|---|
| Ramucirumab + Docetaxel | 263 |
| Placebo + Docetaxel | 267 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Docetaxel | 25.9 | Not reported | 20.6 | 31.1 | Not reported |
| Placebo + Docetaxel | 13.9 | Not reported | 9.7 | 18.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.6
- upper Limit
- 31.1
- value
- 25.9
- group Id
- OG001
- lower Limit
- 9.7
- upper Limit
- 18.0
- value
- 13.9
- denoms
- counts
- group Id
- OG000
- value
- 263
- group Id
- OG001
- value
- 267
- units
- Participants
- description
- ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 millimeter (mm). Tumor-marker results must have normalized. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG000
- title
- Ramucirumab + Docetaxel
- description
- Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG001
- title
- Placebo + Docetaxel
- param Type
- NUMBER
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Randomization to Disease Progression (Up to 29.7 Months)
- title
- Percentage of Participants With an Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice