TriangleNCT00112463 · OUTCOME
Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- During treatment (max of 16 months) and for 1 month following treatment
What was measured
The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study. A summary of the individual toxicities can be found in the AE/SAE results.
Analysis population: All treated participants
Groups in this outcome
Treatment (Single-agent Depsipeptide)
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. romidepsin: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.
| Group | Source count |
|---|---|
| Treatment (Single-agent Depsipeptide) | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Single-agent Depsipeptide) | 13 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- description
- The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study. A summary of the individual toxicities can be found in the AE/SAE results.
- groups
- description
- Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. romidepsin: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.
- id
- OG000
- title
- Treatment (Single-agent Depsipeptide)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- During treatment (max of 16 months) and for 1 month following treatment
- title
- Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice