TriangleNCT01168973 · OUTCOME
Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores
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, 30 days following last infusion (up to Cycle 38, 21 days/cycle)
What was measured
The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Analysis population: Randomized participants grouped according to their assigned treatment at randomization, who had an EQ-5D assessment at a baseline and 30 days post treatment.
Groups in this outcome
Ramucirumab and Docetaxel
On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
Placebo and Docetaxel
On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
| Group | Source count |
|---|---|
| Ramucirumab and Docetaxel | 272 |
| Placebo and Docetaxel | 272 |
Reported measurements
Health State Index Score (n=266, 272)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab and Docetaxel | -0.140 | 0.308 | Not reported | Not reported | Not reported |
| Placebo and Docetaxel | -0.126 | 0.294 | Not reported | Not reported | Not reported |
Health State VAS Score (n=272, 254)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab and Docetaxel | -5.9 | 21.02 | Not reported | Not reported | Not reported |
| Placebo and Docetaxel | -6.1 | 20.31 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.308
- value
- -0.140
- group Id
- OG001
- spread
- 0.294
- value
- -0.126
- title
- Health State Index Score (n=266, 272)
- categories
- measurements
- group Id
- OG000
- spread
- 21.02
- value
- -5.9
- group Id
- OG001
- spread
- 20.31
- value
- -6.1
- title
- Health State VAS Score (n=272, 254)
- denoms
- counts
- group Id
- OG000
- value
- 272
- group Id
- OG001
- value
- 272
- units
- Participants
- description
- The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
- dispersion Type
- Standard Deviation
- groups
- description
- On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
- id
- OG000
- title
- Ramucirumab and Docetaxel
- description
- On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
- id
- OG001
- title
- Placebo and Docetaxel
- param Type
- MEAN
- population Description
- Randomized participants grouped according to their assigned treatment at randomization, who had an EQ-5D assessment at a baseline and 30 days post treatment.
- reporting Status
- POSTED
- time Frame
- Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)
- title
- Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice