TriangleNCT02395666 · OUTCOME
Percentage of Participants With Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage of subjects without an event
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 2 Years
What was measured
To evaluate the preventative activity of DFMO as a single agent in patients with neuroblastoma who are in remission based on: Overall Survival (OS)
Groups in this outcome
Stratum 1
Subjects that are in remission at the end of upfront therapy defined as chemotherapy (5-7 cycles), surgery as indicated, consolidation therapy as indicated, radiation therapy as indicated, anti-GD2 antibody therapy with retinoic acid up to 6 cycles. Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.
Stratum 2
Subjects that are in remission after any previous relapse or refractory therapy. Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.
| Group | Source count |
|---|---|
| Stratum 1 | 100 |
| Stratum 2 | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 | 97 | Not reported | 95 | 99 | Not reported |
| Stratum 2 | 84 | Not reported | 78 | 90 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 95
- upper Limit
- 99
- value
- 97
- group Id
- OG001
- lower Limit
- 78
- upper Limit
- 90
- value
- 84
- denoms
- counts
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- To evaluate the preventative activity of DFMO as a single agent in patients with neuroblastoma who are in remission based on: Overall Survival (OS)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects that are in remission at the end of upfront therapy defined as chemotherapy (5-7 cycles), surgery as indicated, consolidation therapy as indicated, radiation therapy as indicated, anti-GD2 antibody therapy with retinoic acid up to 6 cycles. Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.
- id
- OG000
- title
- Stratum 1
- description
- Subjects that are in remission after any previous relapse or refractory therapy. Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.
- id
- OG001
- title
- Stratum 2
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- 2 Years
- title
- Percentage of Participants With Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- percentage of subjects without an event
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice