TriangleNCT00229203 · OUTCOME
Time to Progression (TTP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed.
What was measured
Time to Progression (TTP):date of first infusion to the date of documented progressive disease which can be defined as \>25 percentage increase in level of serum monoclonal paraprotein.
Analysis population: Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)
Groups in this outcome
Plitidepsin
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
Plitidepsin + Dexamethasone
Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
| Group | Source count |
|---|---|
| Plitidepsin | 29 |
| Plitidepsin + Dexamethasone | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Plitidepsin | 2.3 | Not reported | 1.5 | 2.8 | Not reported |
| Plitidepsin + Dexamethasone | 4.2 | Not reported | 3.4 | 7.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 2.8
- value
- 2.3
- group Id
- OG001
- lower Limit
- 3.4
- upper Limit
- 7.7
- value
- 4.2
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- Time to Progression (TTP):date of first infusion to the date of documented progressive disease which can be defined as \>25 percentage increase in level of serum monoclonal paraprotein.
- dispersion Type
- Full Range
- groups
- description
- Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
- id
- OG000
- title
- Plitidepsin
- description
- Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
- id
- OG001
- title
- Plitidepsin + Dexamethasone
- param Type
- MEDIAN
- population Description
- Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)
- reporting Status
- POSTED
- time Frame
- Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed.
- title
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice