TriangleNCT02872116 · OUTCOME
Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
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
- From randomization until a clinically meaningful decline from baseline in GaCS score (approximately 10 months)
What was measured
TTSD is defined as the the time from randomization until a clinically meaningful decline from baseline in Gastric Cancer Subscale (GaCS) score. A clinically meaningful deterioration is defined as a reduction of 8.2 points in the GaCS score. Subjects who do not deteriorate will be censored at the time of their last GACS assessment. Subjects without baseline GaCS assessment will be censored on the randomization date. Those with baseline GaCS, who do not have any GaCS assessments after randomization will be censored on the day after randomization.
Analysis population: All Treated participants with TTSD measurements
Groups in this outcome
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
Arm 2a: Chemotherapy (XELOX or FOLFOX)
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This arm is a subgroup of the chemotherapy group that acts as a comparison group to Arm 1.
| Group | Source count |
|---|---|
| Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 194 |
| Arm 2a: Chemotherapy (XELOX or FOLFOX) | 193 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | NA | Not reported | 22.64 | NA | Median and upper limits not reached because of insufficient number of events. |
| Arm 2a: Chemotherapy (XELOX or FOLFOX) | 21.03 | Not reported | 12.45 | NA | Upper limits not reached because of insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limits not reached because of insufficient number of events.
- group Id
- OG000
- lower Limit
- 22.64
- upper Limit
- NA
- value
- NA
- comment
- Upper limits not reached because of insufficient number of events.
- group Id
- OG001
- lower Limit
- 12.45
- upper Limit
- NA
- value
- 21.03
- denoms
- counts
- group Id
- OG000
- value
- 194
- group Id
- OG001
- value
- 193
- units
- Participants
- description
- TTSD is defined as the the time from randomization until a clinically meaningful decline from baseline in Gastric Cancer Subscale (GaCS) score. A clinically meaningful deterioration is defined as a reduction of 8.2 points in the GaCS score. Subjects who do not deteriorate will be censored at the time of their last GACS assessment. Subjects without baseline GaCS assessment will be censored on the randomization date. Those with baseline GaCS, who do not have any GaCS assessments after randomization will be censored on the day after randomization.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
- id
- OG000
- title
- Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
- description
- Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This arm is a subgroup of the chemotherapy group that acts as a comparison group to Arm 1.
- id
- OG001
- title
- Arm 2a: Chemotherapy (XELOX or FOLFOX)
- param Type
- MEDIAN
- population Description
- All Treated participants with TTSD measurements
- reporting Status
- POSTED
- time Frame
- From randomization until a clinically meaningful decline from baseline in GaCS score (approximately 10 months)
- title
- Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice