TriangleNCT01168973 · OUTCOME
Percentage of Participants Achieving an Objective Response (Objective Response Rate)
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
- Baseline to measured PD (up to 29 months)
What was measured
Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100.
Analysis population: ITT population: All randomized participants grouped according to their assigned treatment at randomization.
Groups in this outcome
Ramucirumab and Docetaxel
On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
Placebo and Docetaxel
On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
| Group | Source count |
|---|---|
| Ramucirumab and Docetaxel | 628 |
| Placebo and Docetaxel | 625 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab and Docetaxel | 22.9 | Not reported | 19.7 | 26.4 | Not reported |
| Placebo and Docetaxel | 13.6 | Not reported | 11.0 | 16.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.7
- upper Limit
- 26.4
- value
- 22.9
- group Id
- OG001
- lower Limit
- 11.0
- upper Limit
- 16.5
- value
- 13.6
- denoms
- counts
- group Id
- OG000
- value
- 628
- group Id
- OG001
- value
- 625
- units
- Participants
- description
- Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
- id
- OG000
- title
- Ramucirumab and Docetaxel
- description
- On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
- id
- OG001
- title
- Placebo and Docetaxel
- param Type
- NUMBER
- population Description
- ITT population: All randomized participants grouped according to their assigned treatment at randomization.
- reporting Status
- POSTED
- time Frame
- Baseline to measured PD (up to 29 months)
- title
- Percentage of Participants Achieving an Objective Response (Objective Response Rate)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice