TriangleNCT01183780 · OUTCOME
Change From Baseline in EuroQol- 5D (EQ-5D)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and 30-Day Follow-Up (FU) up to 171 Weeks
What was measured
The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.
Analysis population: All randomized participants who had EQ-5D assessed at baseline and 30-day FU.
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 | 308 |
| Placebo + FOLFIRI | 310 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + FOLFIRI | -0.097 | 0.279 | Not reported | Not reported | Not reported |
| Placebo + FOLFIRI | -0.103 | 0.264 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.279
- value
- -0.097
- group Id
- OG001
- spread
- 0.264
- value
- -0.103
- denoms
- counts
- group Id
- OG000
- value
- 308
- group Id
- OG001
- value
- 310
- units
- Participants
- description
- The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- All randomized participants who had EQ-5D assessed at baseline and 30-day FU.
- reporting Status
- POSTED
- time Frame
- Baseline and 30-Day Follow-Up (FU) up to 171 Weeks
- title
- Change From Baseline in EuroQol- 5D (EQ-5D)
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice