TriangleNCT01849848 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to around 44 weeks
What was measured
From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.
Groups in this outcome
SyB L-0501
SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
| Group | Source count |
|---|---|
| SyB L-0501 | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SyB L-0501 | NA | Not reported | NA | NA | Because there was no subject judged as "PR" or higher in this study. |
Complete source fields
- classes
- categories
- measurements
- comment
- Because there was no subject judged as "PR" or higher in this study.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 17
- units
- Participants
- description
- From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
- id
- OG000
- title
- SyB L-0501
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- up to around 44 weeks
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice