TriangleNCT04685135 · OUTCOME
Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
What was measured
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.594 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. Least square mean and CI are from a repeated measures model on the response variable change from baseline in health utility index.
Analysis population: Intent-To-Treat Population includes all participants who are randomized into this study.
Groups in this outcome
Adagrasib
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).
Docetaxel
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.
| Group | Source count |
|---|---|
| Adagrasib | 301 |
| Docetaxel | 152 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adagrasib | -0.0350 | Not reported | -0.0977 | 0.0277 | Not reported |
| Docetaxel | -0.0914 | Not reported | -0.1572 | -0.0256 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.0977
- upper Limit
- 0.0277
- value
- -0.0350
- group Id
- OG001
- lower Limit
- -0.1572
- upper Limit
- -0.0256
- value
- -0.0914
- denoms
- counts
- group Id
- OG000
- value
- 301
- group Id
- OG001
- value
- 152
- units
- Participants
- description
- The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.594 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. Least square mean and CI are from a repeated measures model on the response variable change from baseline in health utility index.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).
- id
- OG000
- title
- Adagrasib
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.
- id
- OG001
- title
- Docetaxel
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Intent-To-Treat Population includes all participants who are randomized into this study.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
- title
- Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score
- type
- SECONDARY
- unit Of Measure
- Score on a scale
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Preserved source evidence · Not medical advice