TriangleNCT03117361 · OUTCOME
Percentage of Participants With Overall Survival at 6 Months
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
- From the date of first drug administration to the date of death (of any cause) or last patient contact, up to 6 months
What was measured
Overall survival (OS) was defined as death of any cause.
Analysis population: 1 died without any valid tumor assessment done 1 discontinued treatment-related AEs
Groups in this outcome
Experimental
Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
| Group | Source count |
|---|---|
| Experimental | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Experimental | 55.6 | Not reported | 6.9 | 100.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.9
- upper Limit
- 100.0
- value
- 55.6
- denoms
- counts
- group Id
- OG000
- value
- 8
- units
- Participants
- description
- Overall survival (OS) was defined as death of any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
- id
- OG000
- title
- Experimental
- param Type
- NUMBER
- population Description
- 1 died without any valid tumor assessment done 1 discontinued treatment-related AEs
- reporting Status
- POSTED
- time Frame
- From the date of first drug administration to the date of death (of any cause) or last patient contact, up to 6 months
- title
- Percentage of Participants With Overall Survival at 6 Months
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice