NCT03912064 · OUTCOME
Overall Survival
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
- Day 92 and Week 60
What was measured
Duration of time from start of treatment to time of death.
Groups in this outcome
Dose Level: 0
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
Dose Level: 1
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
Dose Level: 2
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
| Group | Source count |
|---|---|
| Dose Level: 0 | 18 |
| Dose Level: 1 | 6 |
| Dose Level: 2 | 1 |
Reported measurements
Day 92
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level: 0 | 89 | Not reported | 75 | 100 | Not reported |
| Dose Level: 1 | 100 | Not reported | NA | NA | No death before 150 days, cannot estimate CI |
| Dose Level: 2 | NA | Not reported | NA | NA | Died at day 65, Sample size too small to estimate the rate and CI |
Week 60
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level: 0 | 61 | Not reported | 37 | 83 | Not reported |
| Dose Level: 1 | 67 | Not reported | 29 | 100 | Not reported |
| Dose Level: 2 | NA | Not reported | NA | NA | Died at day 65, Sample size too small to estimate the rate and CI |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 75
- upper Limit
- 100
- value
- 89
- comment
- No death before 150 days, cannot estimate CI
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 100
- comment
- Died at day 65, Sample size too small to estimate the rate and CI
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 92
- categories
- measurements
- group Id
- OG000
- lower Limit
- 37
- upper Limit
- 83
- value
- 61
- group Id
- OG001
- lower Limit
- 29
- upper Limit
- 100
- value
- 67
- comment
- Died at day 65, Sample size too small to estimate the rate and CI
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Week 60
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- Duration of time from start of treatment to time of death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
- id
- OG000
- title
- Dose Level: 0
- description
- 3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
- id
- OG001
- title
- Dose Level: 1
- description
- 10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
- id
- OG002
- title
- Dose Level: 2
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Day 92 and Week 60
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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