TriangleNCT01168973 · OUTCOME
Progression-Free Survival (PFS) Time
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
- Randomization to measured PD or date of death from any cause (up to 29 months)
What was measured
PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
Analysis population: ITT population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 70 participants; placebo and docetaxel arm = 42 participants.
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 | 4.5 | Not reported | 4.2 | 5.3 | Not reported |
| Placebo and Docetaxel | 3.0 | Not reported | 2.8 | 3.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 5.3
- value
- 4.5
- group Id
- OG001
- lower Limit
- 2.8
- upper Limit
- 3.9
- value
- 3.0
- denoms
- counts
- group Id
- OG000
- value
- 628
- group Id
- OG001
- value
- 625
- units
- Participants
- description
- PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
- 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
- MEDIAN
- population Description
- ITT population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 70 participants; placebo and docetaxel arm = 42 participants.
- reporting Status
- POSTED
- time Frame
- Randomization to measured PD or date of death from any cause (up to 29 months)
- title
- Progression-Free Survival (PFS) Time
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice