TriangleNCT03306264 · OUTCOME
AML: Survival Rates at 6 Months, 1 Year, and 2 Years
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At Month 6, Year 1 and 2
What was measured
One-year survival rate was defined as the survival rate at the end of the first year from the date of randomization. The survival rates at 6 months and at 2 years were calculated similarly.
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to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.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
Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: ASTX727 or IV Decitabine | 61 | Not reported | 50 | 71 | Not reported |
Year 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: ASTX727 or IV Decitabine | 44 | Not reported | 33 | 54 | Not reported |
Year 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: ASTX727 or IV Decitabine | 16 | Not reported | 8 | 26 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50
- upper Limit
- 71
- value
- 61
- title
- Month 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33
- upper Limit
- 54
- value
- 44
- title
- Year 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8
- upper Limit
- 26
- value
- 16
- title
- Year 2
- denoms
- counts
- group Id
- OG000
- value
- 87
- units
- Participants
- description
- One-year survival rate was defined as the survival rate at the end of the first year from the date of randomization. The survival rates at 6 months and at 2 years were calculated similarly.
- 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
- NUMBER
- population Description
- Efficacy Analysis Set included all participants who received any amount of study treatment.
- reporting Status
- POSTED
- time Frame
- At Month 6, Year 1 and 2
- title
- AML: Survival Rates at 6 Months, 1 Year, and 2 Years
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice