TriangleNCT03010358 · OUTCOME
Event Free Survival (EFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- The interval between the date of first study treatment and the date of objective signs of disease recurrence, subsequent anti leukemic therapy, or death, whichever is first reported, assessed up to 45 months.
What was measured
Will be summarized descriptively using the Kaplan-Meier estimate. EFS will be censored if entospletinib is discontinued for other reasons (such as drug is no longer available).
Analysis population: Efficacy evaluable population: participants with CLL (Phase I/Phase II)
Groups in this outcome
All Research Participants
The Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol. Phase 1, Dose 1 received entospletinib at Dose Level 1: 400 mg daily (200 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 1, Dose 2 received entospletinib at Dose Level 2: 800 mg daily (400 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 2, MTD: Received entospletinib at Maximum Tolerated Dose (MTD) in combination with obinutuzumab during Dose Expansion phase of study. The MTD was determined to be 800 mg daily (400 mg twice daily).
| Group | Source count |
|---|---|
| All Research Participants | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Research Participants | 24.0 | Not reported | 16 | 28 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16
- upper Limit
- 28
- value
- 24.0
- denoms
- counts
- group Id
- OG000
- value
- 21
- units
- Participants
- description
- Will be summarized descriptively using the Kaplan-Meier estimate. EFS will be censored if entospletinib is discontinued for other reasons (such as drug is no longer available).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol. Phase 1, Dose 1 received entospletinib at Dose Level 1: 400 mg daily (200 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 1, Dose 2 received entospletinib at Dose Level 2: 800 mg daily (400 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 2, MTD: Received entospletinib at Maximum Tolerated Dose (MTD) in combination with obinutuzumab during Dose Expansion phase of study. The MTD was determined to be 800 mg daily (400 mg twice daily).
- id
- OG000
- title
- All Research Participants
- param Type
- MEDIAN
- population Description
- Efficacy evaluable population: participants with CLL (Phase I/Phase II)
- reporting Status
- POSTED
- time Frame
- The interval between the date of first study treatment and the date of objective signs of disease recurrence, subsequent anti leukemic therapy, or death, whichever is first reported, assessed up to 45 months.
- title
- Event Free Survival (EFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice