TriangleNCT03762018 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until death from any cause, up to 52 months.
What was measured
Overall survival is defined as the time from the date of randomisation until death from any cause. Data for patients who are not reported as having died at the date of analysis will be censored at the date when they were last known to be alive. Data for patients without post-baseline information will be censored at the date of randomization (plus 1 day).
Analysis population: Efficacy population (Intention-To-Treat cohort of all randomised patients)
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 | 200 |
| Bevacizumab Plus Chemotherapy | 200 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab Plus Bevacizumab Plus Chemotherapy | 20.5 | Not reported | 17.5 | 23.3 | Not reported |
| Bevacizumab Plus Chemotherapy | 18.1 | Not reported | 15.7 | 20.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.06
- estimate Comment
- The HR for atezolizumab plus bevacizumab plus chemotherapy versus bevacizumab plus chemotherapy is provided.
- group Description
- The study was designed to test the hypothesis that addition of Atezolizumab to Bevacizumab and chemotherapy leads to an increase in median OS from 17 months with Bevacizumab and chemotherapy alone to 24 months. According to the study design, this corresponds to a HR of 0.708. Using the log-rank test stratified by the randomization stratification factors (histological subtype and stage), 284 deaths were required to achieve the trial goal with 82.1% power at a 1-sided significance level of 2.5%.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.14
- p Value Comment
- 1-sided significance level of 2.5%.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.84
- statistical Comment
- Univariate stratified by the randomization stratification factors (histological subtype and stage) Cox for OS with treatment effect only
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.06
- estimate Comment
- The HR for atezolizumab plus bevacizumab plus chemotherapy versus bevacizumab plus chemotherapy is provided.
- group Description
- The study was designed to test the hypothesis that addition of Atezolizumab to Bevacizumab and chemotherapy leads to an increase in median OS from 17 months with Bevacizumab and chemotherapy alone to 24 months. According to the study design, this corresponds to a HR of 0.708. Using the log-rank test stratified by the randomization stratification factors (histological subtype and stage), 284 deaths were required to achieve the trial goal with 82.1% power at a 1-sided significance level of 2.5%.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.14
- p Value Comment
- 1-sided significance level of 2.5%.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.84
- statistical Comment
- Univariate stratified by the randomization stratification factors (histological subtype and stage) Cox for OS with treatment effect only
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.5
- upper Limit
- 23.3
- value
- 20.5
- group Id
- OG001
- lower Limit
- 15.7
- upper Limit
- 20.9
- value
- 18.1
- denoms
- counts
- group Id
- OG000
- value
- 200
- group Id
- OG001
- value
- 200
- units
- Participants
- description
- Overall survival is defined as the time from the date of randomisation until death from any cause. Data for patients who are not reported as having died at the date of analysis will be censored at the date when they were last known to be alive. Data for patients without post-baseline information will be censored at the date of randomization (plus 1 day).
- 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
- MEDIAN
- population Description
- Efficacy population (Intention-To-Treat cohort of all randomised patients)
- reporting Status
- POSTED
- time Frame
- From randomization until death from any cause, up to 52 months.
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice