TriangleNCT02435433 · OUTCOME
Progression Free Survival (PFS)
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
- From Randomization to Objective Progression or Death from Any Cause (Up to 28 Months)
What was measured
Progression-free survival is defined as time from the date of randomization to the date of first observation of objective progression or death from any cause.
Analysis population: All randomized participants. Participants were censored in the Ramucirumab arm = 25 and in the Placebo arm = 9. All randomized participants (including the censored participants) were included in the analyses.
Groups in this outcome
Ramucirumab + BSC
8 mg/kg ramucirumab administered as an intravenous IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
Placebo + BSC
Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
| Group | Source count |
|---|---|
| Ramucirumab + BSC | 197 |
| Placebo + BSC | 95 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + BSC | 2.83 | Not reported | 2.76 | 4.11 | Not reported |
| Placebo + BSC | 1.61 | Not reported | 1.45 | 2.69 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.339
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.603
- estimate Comment
- Stratified analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.452
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.339
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.603
- estimate Comment
- Stratified analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.452
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.76
- upper Limit
- 4.11
- value
- 2.83
- group Id
- OG001
- lower Limit
- 1.45
- upper Limit
- 2.69
- value
- 1.61
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 95
- units
- Participants
- description
- Progression-free survival is defined as time from the date of randomization to the date of first observation of objective progression or death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 8 mg/kg ramucirumab administered as an intravenous IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
- id
- OG000
- title
- Ramucirumab + BSC
- description
- Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
- id
- OG001
- title
- Placebo + BSC
- param Type
- MEDIAN
- population Description
- All randomized participants. Participants were censored in the Ramucirumab arm = 25 and in the Placebo arm = 9. All randomized participants (including the censored participants) were included in the analyses.
- reporting Status
- POSTED
- time Frame
- From Randomization to Objective Progression or Death from Any Cause (Up to 28 Months)
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice