TriangleNCT02287233 · OUTCOME
Duration of CR Plus CRh
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
- Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)
What was measured
Duration of CR + CRh is defined as the time from date that a participant achieved CR or CRh to the first date of relapse, clinical disease progression or death due to disease progression, whichever occurred earliest. Duration of CR + CRh was estimated using Kaplan-Meier methodology. If a participant was still responding at the data cutoff date, then the participant's data were censored at their last disease assessment date. Disease assessment data after the onset of any post-treatment therapy were not included in the analysis.
Analysis population: Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CR or CRh
Groups in this outcome
Phase 1+2: 600 mg Venetoclax + LDAC
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
| Group | Source count |
|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 11.0 | Not reported | 6.1 | 28.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.1
- upper Limit
- 28.2
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- description
- Duration of CR + CRh is defined as the time from date that a participant achieved CR or CRh to the first date of relapse, clinical disease progression or death due to disease progression, whichever occurred earliest. Duration of CR + CRh was estimated using Kaplan-Meier methodology. If a participant was still responding at the data cutoff date, then the participant's data were censored at their last disease assessment date. Disease assessment data after the onset of any post-treatment therapy were not included in the analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
- id
- OG000
- title
- Phase 1+2: 600 mg Venetoclax + LDAC
- param Type
- MEDIAN
- population Description
- Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CR or CRh
- reporting Status
- POSTED
- time Frame
- Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)
- title
- Duration of CR Plus CRh
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice