TriangleNCT02367781 · OUTCOME
OS as Determined by the Investigator Using Recist v1.1 in the ITT Population
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
- Up to approximately 41 months after first subject enrolled
What was measured
OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
Analysis population: The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment.
Groups in this outcome
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Arm B (Nab-Paclitaxel+Carboplatin)
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 483 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 240 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 17.0 | Not reported | 14.9 | 19.7 | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 13.5 | Not reported | 11.9 | 17.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.689
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.017
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0732
- param Type
- Hazard Ratio (HR)
- param Value
- 0.837
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.689
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.017
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0732
- param Type
- Hazard Ratio (HR)
- param Value
- 0.837
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.9
- upper Limit
- 19.7
- value
- 17.0
- group Id
- OG001
- lower Limit
- 11.9
- upper Limit
- 17.7
- value
- 13.5
- denoms
- counts
- group Id
- OG000
- value
- 483
- group Id
- OG001
- value
- 240
- units
- Participants
- description
- OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
- id
- OG000
- title
- Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
- description
- Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
- id
- OG001
- title
- Arm B (Nab-Paclitaxel+Carboplatin)
- param Type
- MEDIAN
- population Description
- The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 41 months after first subject enrolled
- title
- OS as Determined by the Investigator Using Recist v1.1 in the ITT Population
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice