TriangleNCT03306264 · OUTCOME
AML: Duration of Complete Response and Combined CR and CRh Based on IWG 2003 AML Response Criteria
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
- Up to approximately 2.4 years
What was measured
Duration of CR was defined as the time interval from the first CR to time of relapse. Duration of combined CR and CRh was defined as the time interval from the first CR or CRh to time of relapse. Duration of CR and combined CR and CRh was presented using a Kaplan-Meier estimate.
Analysis population: Efficacy Analysis Set included all participants who received any amount of study treatment.
Groups in this outcome
AML: ASTX727 or IV Decitabine
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
| Group | Source count |
|---|---|
| AML: ASTX727 or IV Decitabine | 87 |
Reported measurements
Duration of Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: ASTX727 or IV Decitabine | 6.9 | Not reported | 3.4 | 11.5 | Not reported |
Duration of Combined CR and CRh
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: ASTX727 or IV Decitabine | 9.0 | Not reported | 3.4 | 11.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.4
- upper Limit
- 11.5
- value
- 6.9
- title
- Duration of Complete Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.4
- upper Limit
- 11.5
- value
- 9.0
- title
- Duration of Combined CR and CRh
- denoms
- counts
- group Id
- OG000
- value
- 87
- units
- Participants
- description
- Duration of CR was defined as the time interval from the first CR to time of relapse. Duration of combined CR and CRh was defined as the time interval from the first CR or CRh to time of relapse. Duration of CR and combined CR and CRh was presented using a Kaplan-Meier estimate.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
- id
- OG000
- title
- AML: ASTX727 or IV Decitabine
- param Type
- MEDIAN
- population Description
- Efficacy Analysis Set included all participants who received any amount of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 2.4 years
- title
- AML: Duration of Complete Response and Combined CR and CRh Based on IWG 2003 AML Response Criteria
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice