TriangleNCT01183780 · OUTCOME
Overall Survival (OS)
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 Date of Death from Any Cause Up to 39.36 Months
What was measured
OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.
Analysis population: All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.
Groups in this outcome
Ramucirumab + FOLFIRI
On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
Placebo + FOLFIRI
On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
| Group | Source count |
|---|---|
| Ramucirumab + FOLFIRI | 536 |
| Placebo + FOLFIRI | 536 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + FOLFIRI | 13.3 | Not reported | 12.4 | 14.5 | Not reported |
| Placebo + FOLFIRI | 11.7 | Not reported | 10.8 | 12.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.730
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.976
- estimate Comment
- The estimation was performed on stratified data.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0219
- param Type
- Hazard Ratio (HR)
- param Value
- 0.844
- statistical Comment
- The analysis was performed on stratified data.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.730
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.976
- estimate Comment
- The estimation was performed on stratified data.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0219
- param Type
- Hazard Ratio (HR)
- param Value
- 0.844
- statistical Comment
- The analysis was performed on stratified data.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.4
- upper Limit
- 14.5
- value
- 13.3
- group Id
- OG001
- lower Limit
- 10.8
- upper Limit
- 12.7
- value
- 11.7
- denoms
- counts
- group Id
- OG000
- value
- 536
- group Id
- OG001
- value
- 536
- units
- Participants
- description
- OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
- id
- OG000
- title
- Ramucirumab + FOLFIRI
- description
- On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
- id
- OG001
- title
- Placebo + FOLFIRI
- param Type
- MEDIAN
- population Description
- All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.
- reporting Status
- POSTED
- time Frame
- Randomization to Date of Death from Any Cause Up to 39.36 Months
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice