TriangleNCT04685135 · OUTCOME
Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden 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 sclae
- 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 Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average symptom burden index score assesses the following six items (Appetite loss, fatigue, cough, shortness of breath, blood in sputum, pain) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The average symptom burden score is average of all the 6 items ranging from 0 to 100 where high score represent worst outcome. Least square mean and CI are from a repeated measures model on the response variable change from baseline in average symptom burden index score.
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 | -5.8 | Not reported | -9.0 | -2.5 | Not reported |
| Docetaxel | 3.2 | Not reported | -0.4 | 6.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -9.0
- upper Limit
- -2.5
- value
- -5.8
- group Id
- OG001
- lower Limit
- -0.4
- upper Limit
- 6.7
- value
- 3.2
- denoms
- counts
- group Id
- OG000
- value
- 301
- group Id
- OG001
- value
- 152
- units
- Participants
- description
- The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average symptom burden index score assesses the following six items (Appetite loss, fatigue, cough, shortness of breath, blood in sputum, pain) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The average symptom burden score is average of all the 6 items ranging from 0 to 100 where high score represent worst outcome. Least square mean and CI are from a repeated measures model on the response variable change from baseline in average symptom burden index score.
- 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 in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score
- type
- SECONDARY
- unit Of Measure
- Score on a sclae
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice