TriangleNCT02763579 · OUTCOME
Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)
What was measured
Objective response (OR) is defined as complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1.
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 | 76.7 | Not reported | 70.29 | 82.38 | Not reported |
| Atezolizumab + Carboplatin + Etoposide | 74.1 | Not reported | 67.50 | 80.03 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.37
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Odds Ratio (OR)
- param Value
- 0.87
Complete source fields
- analyses
- ci Lower Limit
- 0.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.37
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Odds Ratio (OR)
- param Value
- 0.87
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 70.29
- upper Limit
- 82.38
- value
- 76.7
- group Id
- OG001
- lower Limit
- 67.50
- upper Limit
- 80.03
- value
- 74.1
- denoms
- counts
- group Id
- OG000
- value
- 202
- group Id
- OG001
- value
- 201
- units
- Participants
- description
- Objective response (OR) is defined as complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1.
- 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
- NUMBER
- 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 partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)
- title
- Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice