TriangleNCT00561470 · 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
- Inter-Quartile Range
- Time frame
- From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)
What was measured
Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.
Analysis population: Intent-to-treat population (ITT) - all participants who gave informed consent and were randomized.
Groups in this outcome
Placebo/FOLFIRI
Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
Aflibercept/FOLFIRI
Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
| Group | Source count |
|---|---|
| Placebo/FOLFIRI | 614 |
| Aflibercept/FOLFIRI | 612 |
| Group | Source count |
|---|---|
| Placebo/FOLFIRI | 460 |
| Aflibercept/FOLFIRI | 403 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo/FOLFIRI | 12.06 | Not reported | 6.83 | 21.03 | Not reported |
| Aflibercept/FOLFIRI | 13.50 | Not reported | 7.62 | 25.59 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.713
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.34
- ci Upper Limit
- 0.937
- estimate Comment
- Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0032
- p Value Comment
- Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.
- param Type
- Stratified Hazard Ratio
- param Value
- 0.817
- statistical Method
- Stratified Log-Rank test
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.713
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.34
- ci Upper Limit
- 0.937
- estimate Comment
- Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0032
- p Value Comment
- Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.
- param Type
- Stratified Hazard Ratio
- param Value
- 0.817
- statistical Method
- Stratified Log-Rank test
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.83
- upper Limit
- 21.03
- value
- 12.06
- group Id
- OG001
- lower Limit
- 7.62
- upper Limit
- 25.59
- value
- 13.50
- denom Units Selected
- Participants
- denoms
- counts
- group Id
- OG000
- value
- 614
- group Id
- OG001
- value
- 612
- units
- Participants
- counts
- group Id
- OG000
- value
- 460
- group Id
- OG001
- value
- 403
- units
- Events (Death)
- description
- Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- id
- OG000
- title
- Placebo/FOLFIRI
- description
- Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- id
- OG001
- title
- Aflibercept/FOLFIRI
- param Type
- MEDIAN
- population Description
- Intent-to-treat population (ITT) - all participants who gave informed consent and were randomized.
- reporting Status
- POSTED
- time Frame
- From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)
- title
- Overall Survival (OS)
- type
- PRIMARY
- type Units Analyzed
- Events (Death)
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice