TriangleNCT02784171 · OUTCOME
Phase III: Overall Survival Defined as Time From Randomization to the Date of Death From Any Cause
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
- Survival was monitored continuously throughout the study and during follow-up. Patients were evaluated for each cycle, 4 weeks after discontinuation, every 12 weeks until progression, and then every 24 weeks until death, an average of 16.2 months.
What was measured
Overall survival was defined as time from the day of randomization to death for patients died. For patients still alive at time of data-cutoff for analysis, it was censored at the last day the patients were known alive as the last of all dates .
Analysis population: Intention to treat population.
Groups in this outcome
Arm A - Cisplatin/Pemetrexed
Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed
Arm B - Cisplatin/Pemetrexed/Pembrolizumab
Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed Pembrolizumab
| Group | Source count |
|---|---|
| Arm A - Cisplatin/Pemetrexed | 218 |
| Arm B - Cisplatin/Pemetrexed/Pembrolizumab | 222 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A - Cisplatin/Pemetrexed | 16.13 | Not reported | 13.08 | 18.17 | Not reported |
| Arm B - Cisplatin/Pemetrexed/Pembrolizumab | 17.28 | Not reported | 14.36 | 21.29 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0372
- statistical Method
- Log Rank
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0372
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.08
- upper Limit
- 18.17
- value
- 16.13
- group Id
- OG001
- lower Limit
- 14.36
- upper Limit
- 21.29
- value
- 17.28
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 222
- units
- Participants
- description
- Overall survival was defined as time from the day of randomization to death for patients died. For patients still alive at time of data-cutoff for analysis, it was censored at the last day the patients were known alive as the last of all dates .
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed
- id
- OG000
- title
- Arm A - Cisplatin/Pemetrexed
- description
- Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed Pembrolizumab
- id
- OG001
- title
- Arm B - Cisplatin/Pemetrexed/Pembrolizumab
- param Type
- MEDIAN
- population Description
- Intention to treat population.
- reporting Status
- POSTED
- time Frame
- Survival was monitored continuously throughout the study and during follow-up. Patients were evaluated for each cycle, 4 weeks after discontinuation, every 12 weeks until progression, and then every 24 weeks until death, an average of 16.2 months.
- title
- Phase III: Overall Survival Defined as Time From Randomization to the Date of Death From Any Cause
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice