TriangleNCT03372057 · OUTCOME
DOR as Assessed by the IRC Using the Lugano Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- month
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 70 months
What was measured
DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of PD or death due to any cause. Participants who withdrew from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.
Analysis population: Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only.
Groups in this outcome
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
| Group | Source count |
|---|---|
| Expansion Phase | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion Phase | 7.9 | Not reported | 6.4 | 21.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.4
- upper Limit
- 21.00
- value
- 7.9
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of PD or death due to any cause. Participants who withdrew from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
- id
- OG000
- title
- Expansion Phase
- param Type
- MEDIAN
- population Description
- Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only.
- reporting Status
- POSTED
- time Frame
- Up to 70 months
- title
- DOR as Assessed by the IRC Using the Lugano Criteria
- type
- SECONDARY
- unit Of Measure
- month
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice