TriangleNCT02784171 · OUTCOME
Phase III: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression
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
- PFS was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.
What was measured
PFS was calculated for all randomized patients from the day of randomization until the first observation of disease progression (date of objective relapse or progression of Relapse/Progression Report) or death due to any cause (recorded in Date/Cause of Death Section of Death Report). The primary analysis for PFS was based on the progression evaluated in this study using mesothelioma-modified RECIST (mRECIST) conducted by blinded independent review (BICR).
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 | 7.16 | Not reported | 6.83 | 7.69 | Not reported |
| Arm B - Cisplatin/Pemetrexed/Pembrolizumab | 7.13 | Not reported | 6.93 | 8.12 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.83
- upper Limit
- 7.69
- value
- 7.16
- group Id
- OG001
- lower Limit
- 6.93
- upper Limit
- 8.12
- value
- 7.13
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 222
- units
- Participants
- description
- PFS was calculated for all randomized patients from the day of randomization until the first observation of disease progression (date of objective relapse or progression of Relapse/Progression Report) or death due to any cause (recorded in Date/Cause of Death Section of Death Report). The primary analysis for PFS was based on the progression evaluated in this study using mesothelioma-modified RECIST (mRECIST) conducted by blinded independent review (BICR).
- 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
- reporting Status
- POSTED
- time Frame
- PFS was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.
- title
- Phase III: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice