TriangleNCT03306264 · OUTCOME
MDS/CMML: Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization up to approximately 2.7 years
What was measured
OS was defined as time from the date of randomization to the date of death from any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. Overall survival was presented using a Kaplan-Meier estimate.
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.
Groups in this outcome
MDS or CMML: ASTX727 or IV Decitabine
Participants with MDS or CMML 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, treatment discontinuation for other reasons, or withdrawal from the study.
| Group | Source count |
|---|---|
| MDS or CMML: ASTX727 or IV Decitabine | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MDS or CMML: ASTX727 or IV Decitabine | 966.0 | Not reported | 809.0 | NA | The upper limit of the 95% CI was not reached at time of data cut-off due to insufficient number of participants with an event. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the 95% CI was not reached at time of data cut-off due to insufficient number of participants with an event.
- group Id
- OG000
- lower Limit
- 809.0
- upper Limit
- NA
- value
- 966.0
- denoms
- counts
- group Id
- OG000
- value
- 58
- units
- Participants
- description
- OS was defined as time from the date of randomization to the date of death from any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. Overall survival was presented using a Kaplan-Meier estimate.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with MDS or CMML 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, treatment discontinuation for other reasons, or withdrawal from the study.
- id
- OG000
- title
- MDS or CMML: ASTX727 or IV Decitabine
- param Type
- MEDIAN
- 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.
- reporting Status
- POSTED
- time Frame
- From randomization up to approximately 2.7 years
- title
- MDS/CMML: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice