NCT03306264 · OUTCOME
AML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML · Source last updated 2024-08-27
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
- Up to approximately 2.4 years
What was measured
Transfusion independence was defined as no transfusion for 56 consecutive days or more (112 days) after the first dose of study treatment while maintaining hemoglobin ≥8 grams/deciliter (g/dL) (RBC TI) or maintaining platelets ≥20×109/L (platelet TI).
Analysis population: Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those subjects who were evaluable for this outcome measure at specified category.
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to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| AML: ASTX727 or IV Decitabine | 37 |
|---|
Reported measurements
RBC TI ≥56 Days
Analysis denominator · Participants
| Group | Source count |
|---|
| AML: ASTX727 or IV Decitabine | 37 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AML: ASTX727 or IV Decitabine | 37.8 | Not reported | 22.5 | 55.2 | Not reported |
|---|
RBC TI ≥112 Days
Analysis denominator · Participants
| Group | Source count |
|---|
| AML: ASTX727 or IV Decitabine | 37 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AML: ASTX727 or IV Decitabine | 24.3 | Not reported | 11.8 | 41.2 | Not reported |
|---|
Platelet TI ≥56 Days
Analysis denominator · Participants
| Group | Source count |
|---|
| AML: ASTX727 or IV Decitabine | 14 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AML: ASTX727 or IV Decitabine | 35.7 | Not reported | 12.8 | 64.9 | Not reported |
|---|
Platelet TI ≥112 Days
Analysis denominator · Participants
| Group | Source count |
|---|
| AML: ASTX727 or IV Decitabine | 14 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AML: ASTX727 or IV Decitabine | 28.6 | Not reported | 8.4 | 58.1 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.5
- upper Limit
- 55.2
- value
- 37.8
- title
- RBC TI ≥56 Days
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.8
- upper Limit
- 41.2
- value
- 24.3
- title
- RBC TI ≥112 Days
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.8
- upper Limit
- 64.9
- value
- 35.7
- title
- Platelet TI ≥56 Days
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.4
- upper Limit
- 58.1
- value
- 28.6
- title
- Platelet TI ≥112 Days
- description
- Transfusion independence was defined as no transfusion for 56 consecutive days or more (112 days) after the first dose of study treatment while maintaining hemoglobin ≥8 grams/deciliter (g/dL) (RBC TI) or maintaining platelets ≥20×109/L (platelet TI).
- 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. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those subjects who were evaluable for this outcome measure at specified category.
- reporting Status
- POSTED
- time Frame
- Up to approximately 2.4 years
- title
- AML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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