TriangleNCT03372057 · OUTCOME
Duration of Response (DOR) as Assessed by the Investigator 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 progressive disease (PD) or death due to any cause. Participants who withdraw 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: Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.
Groups in this outcome
Dose Optimization Phase: Cohort 1
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
| Group | Source count |
|---|---|
| Dose Optimization Phase: Cohort 1 | 5 |
| Dose Optimization Phase: Cohort 2 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Optimization Phase: Cohort 1 | 4.22 | Not reported | 1.87 | NA | Insufficient number of participants with events to calculate upper confidence intervals. |
| Dose Optimization Phase: Cohort 2 | 3.32 | Not reported | 1.77 | NA | Insufficient number of participants with events to calculate upper confidence intervals. |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of participants with events to calculate upper confidence intervals.
- group Id
- OG000
- lower Limit
- 1.87
- upper Limit
- NA
- value
- 4.22
- comment
- Insufficient number of participants with events to calculate upper confidence intervals.
- group Id
- OG001
- lower Limit
- 1.77
- upper Limit
- NA
- value
- 3.32
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- 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 progressive disease (PD) or death due to any cause. Participants who withdraw 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 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
- id
- OG000
- title
- Dose Optimization Phase: Cohort 1
- description
- Duvelisib 75 mg PO BID, administered in 28-day cycles.
- id
- OG001
- title
- Dose Optimization Phase: Cohort 2
- param Type
- MEDIAN
- population Description
- Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.
- reporting Status
- POSTED
- time Frame
- Up to 70 months
- title
- Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria
- type
- SECONDARY
- unit Of Measure
- month
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice