TriangleNCT03117361 · OUTCOME
Overall Response Rate
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 at least one disease assessment, up to 100 weeks
What was measured
The primary endpoint was overall response rate (ORR) (including stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\] and partial response \[PR\]), according to the IMWG response criteria.
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 | 12.5 | Not reported | 0.3 | 52.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.3
- upper Limit
- 52.7
- value
- 12.5
- denoms
- counts
- group Id
- OG000
- value
- 8
- units
- Participants
- description
- The primary endpoint was overall response rate (ORR) (including stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\] and partial response \[PR\]), according to the IMWG response criteria.
- 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 at least one disease assessment, up to 100 weeks
- title
- Overall Response Rate
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice