TriangleNCT03066778 · 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
- Up to approximately 30.5 months
What was measured
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow up. The OS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol.
Analysis population: The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
Groups in this outcome
Pembrolizumab+EP
During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
Placebo+EP
During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
| Group | Source count |
|---|---|
| Pembrolizumab+EP | 228 |
| Placebo+EP | 225 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab+EP | 10.8 | Not reported | 9.2 | 12.9 | Not reported |
| Placebo+EP | 9.7 | Not reported | 8.6 | 10.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.98
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.01643
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Comment
- One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.98
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.01643
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Comment
- One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.2
- upper Limit
- 12.9
- value
- 10.8
- group Id
- OG001
- lower Limit
- 8.6
- upper Limit
- 10.7
- value
- 9.7
- denoms
- counts
- group Id
- OG000
- value
- 228
- group Id
- OG001
- value
- 225
- units
- Participants
- description
- OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow up. The OS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
- id
- OG000
- title
- Pembrolizumab+EP
- description
- During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
- id
- OG001
- title
- Placebo+EP
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 30.5 months
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice