TriangleNCT01170663 · OUTCOME
Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
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, end of therapy (up to 103 weeks)
What was measured
The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale \[1 (no problem), 2 (some problems), and 3 (major problems)\]. These combinations of responses 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 participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations.
Groups in this outcome
Ramucirumab (IMC-1211B) Plus Paclitaxel
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo Plus Paclitaxel
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
| Group | Source count |
|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 205 |
| Placebo Plus Paclitaxel | 201 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | -0.16 | 0.279 | Not reported | Not reported | Not reported |
| Placebo Plus Paclitaxel | -0.19 | 0.337 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.279
- value
- -0.16
- group Id
- OG001
- spread
- 0.337
- value
- -0.19
- denoms
- counts
- group Id
- OG000
- value
- 205
- group Id
- OG001
- value
- 201
- units
- Participants
- description
- The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale \[1 (no problem), 2 (some problems), and 3 (major problems)\]. These combinations of responses 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
- 8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
- id
- OG000
- title
- Ramucirumab (IMC-1211B) Plus Paclitaxel
- description
- Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
- id
- OG001
- title
- Placebo Plus Paclitaxel
- param Type
- MEAN
- population Description
- All participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations.
- reporting Status
- POSTED
- time Frame
- Baseline, end of therapy (up to 103 weeks)
- title
- Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice