TriangleNCT03146650 · OUTCOME
Overall Survival (OS)
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
- Up to 2 years from start of treatment
What was measured
Overall survival (OS) is defined as time in months from the date of first study treatment to the date of death or withdrawal from study, whichever comes first. The percentage of patients alive at 6 months, 12 months, and 24 months will be reported. All patients who receive at least one dose of nivolumab will be included in the secondary analyses of OS.
Analysis population: Patients with Adenoid Cystic Carcinoma only.
Groups in this outcome
Nivolumab + Ipilimumab
Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
| Group | Source count |
|---|---|
| Nivolumab + Ipilimumab | 19 |
Reported measurements
Overall Survival at 6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Ipilimumab | 89.47 | Not reported | 76.69 | 100 | Not reported |
Overall Survival at 12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Ipilimumab | 73.68 | Not reported | 56.32 | 96.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 76.69
- upper Limit
- 100
- value
- 89.47
- title
- Overall Survival at 6 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56.32
- upper Limit
- 96.4
- value
- 73.68
- title
- Overall Survival at 12 months
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- description
- Overall survival (OS) is defined as time in months from the date of first study treatment to the date of death or withdrawal from study, whichever comes first. The percentage of patients alive at 6 months, 12 months, and 24 months will be reported. All patients who receive at least one dose of nivolumab will be included in the secondary analyses of OS.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
- id
- OG000
- title
- Nivolumab + Ipilimumab
- param Type
- NUMBER
- population Description
- Patients with Adenoid Cystic Carcinoma only.
- reporting Status
- POSTED
- time Frame
- Up to 2 years from start of treatment
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice