TriangleNCT02763579 · OUTCOME
Duration of Overall Survival (OS) in the Global 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
- Baseline until death from any cause (up to approximately 23 months)
What was measured
OS is defined as the time from randomization to death from any cause.
Analysis population: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
Groups in this outcome
Placebo + Carboplatin + Etoposide
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Atezolizumab + Carboplatin + Etoposide
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
| Group | Source count |
|---|---|
| Placebo + Carboplatin + Etoposide | 202 |
| Atezolizumab + Carboplatin + Etoposide | 201 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Carboplatin + Etoposide | 10.3 | 9.3 | 9.3 | 11.3 | Not reported |
| Atezolizumab + Carboplatin + Etoposide | 12.3 | 10.8 | 10.8 | 15.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.91
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0069
- param Type
- Stratified Hazard Ratio
- param Value
- 0.70
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.91
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0069
- param Type
- Stratified Hazard Ratio
- param Value
- 0.70
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.3
- spread
- 9.3
- upper Limit
- 11.3
- value
- 10.3
- group Id
- OG001
- lower Limit
- 10.8
- spread
- 10.8
- upper Limit
- 15.9
- value
- 12.3
- denoms
- counts
- group Id
- OG000
- value
- 202
- group Id
- OG001
- value
- 201
- units
- Participants
- description
- OS is defined as the time from randomization to death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
- id
- OG000
- title
- Placebo + Carboplatin + Etoposide
- description
- Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
- id
- OG001
- title
- Atezolizumab + Carboplatin + Etoposide
- param Type
- MEDIAN
- population Description
- The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
- reporting Status
- POSTED
- time Frame
- Baseline until death from any cause (up to approximately 23 months)
- title
- Duration of Overall Survival (OS) in the Global Population
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice