TriangleNCT03762018 · OUTCOME
Quality of Life (QoL)
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
- 95% Confidence Interval
- Time frame
- From randomization until 12 weeks after treatment start, up to 52 months.
What was measured
QoL is assessed by the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) an 8-item questionnaire including five symptoms associated with mesothelioma (i.e., appetite loss, fatigue, cough, dyspnoea, and pain) and three items addressing symptomatic distress, normal activity, and global QoL. All items are measured by visual analogue scales (VAS) using 100-mm lines to assess the intensity of each item based on patient responses within the time frame of the past day. Each item is assigned an individual score corresponding to the length of the line representing intensity as marked by the patient on a 0-100 scale, with 0 as the best rating (i.e., no symptom distress, no interference with activity level, or best possible health-related quality of life) and 100-mm as the worst rating. The primary QoL endpoint is the change in the LCSS total score (average of all 8 items) from baseline to 12 weeks after treatment start.
Analysis population: QoL cohort: all randomized patients who had baseline assessment and at least one on-treatment post-baseline score for any LCSS-Meso item
Groups in this outcome
Atezolizumab Plus Bevacizumab Plus Chemotherapy
Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Bevacizumab Plus Chemotherapy
Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
| Group | Source count |
|---|---|
| Atezolizumab Plus Bevacizumab Plus Chemotherapy | 157 |
| Bevacizumab Plus Chemotherapy | 155 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab Plus Bevacizumab Plus Chemotherapy | 0.4 | Not reported | -2.3 | 3.0 | Not reported |
| Bevacizumab Plus Chemotherapy | 2.1 | Not reported | -0.4 | 4.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.3
- upper Limit
- 3.0
- value
- 0.4
- group Id
- OG001
- lower Limit
- -0.4
- upper Limit
- 4.7
- value
- 2.1
- denoms
- counts
- group Id
- OG000
- value
- 157
- group Id
- OG001
- value
- 155
- units
- Participants
- description
- QoL is assessed by the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) an 8-item questionnaire including five symptoms associated with mesothelioma (i.e., appetite loss, fatigue, cough, dyspnoea, and pain) and three items addressing symptomatic distress, normal activity, and global QoL. All items are measured by visual analogue scales (VAS) using 100-mm lines to assess the intensity of each item based on patient responses within the time frame of the past day. Each item is assigned an individual score corresponding to the length of the line representing intensity as marked by the patient on a 0-100 scale, with 0 as the best rating (i.e., no symptom distress, no interference with activity level, or best possible health-related quality of life) and 100-mm as the worst rating. The primary QoL endpoint is the change in the LCSS total score (average of all 8 items) from baseline to 12 weeks after treatment start.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
- id
- OG000
- title
- Atezolizumab Plus Bevacizumab Plus Chemotherapy
- description
- Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
- id
- OG001
- title
- Bevacizumab Plus Chemotherapy
- param Type
- MEAN
- population Description
- QoL cohort: all randomized patients who had baseline assessment and at least one on-treatment post-baseline score for any LCSS-Meso item
- reporting Status
- POSTED
- time Frame
- From randomization until 12 weeks after treatment start, up to 52 months.
- title
- Quality of Life (QoL)
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice