TriangleNCT01183780 · 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 38.01 Months
What was measured
PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) \[according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1\] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.
Analysis population: All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.
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 | 5.7 | Not reported | 5.5 | 6.2 | Not reported |
| Placebo + FOLFIRI | 4.5 | Not reported | 4.2 | 5.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.697
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.903
- estimate Comment
- Analysis was performed on stratified data.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0005
- param Type
- Hazard Ratio (HR)
- param Value
- 0.793
- statistical Comment
- Analysis was performed on stratified data.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.697
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.903
- estimate Comment
- Analysis was performed on stratified data.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0005
- param Type
- Hazard Ratio (HR)
- param Value
- 0.793
- statistical Comment
- Analysis was performed on stratified data.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 6.2
- value
- 5.7
- group Id
- OG001
- lower Limit
- 4.2
- upper Limit
- 5.4
- value
- 4.5
- denoms
- counts
- group Id
- OG000
- value
- 536
- group Id
- OG001
- value
- 536
- units
- Participants
- description
- PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) \[according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1\] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.
- 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 = 60; Placebo + FOLFIRI = 42.
- reporting Status
- POSTED
- time Frame
- Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months
- title
- Progression-free Survival (PFS) Time
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice