Comparison · NCT03306264-6213a300
MDS or CMML: IV Decitabine vs MDS or CMML: ASTX727: MDS/CMML: Number of Participants With Grade 3 or Higher TEAEs
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. MDS or CMML: IV Decitabine vs MDS or CMML: ASTX727: MDS/CMML: Number of Participants With Grade 3 or Higher TEAEs. Trial comparisons, record NCT03306264-6213a300. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03306264-6213a300
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.674 | 0.59 | 0.748 | wilson | |
| Risk in group 2 | 0.931 | 0.874 | 0.963 | wilson | |
| Risk difference, group 1 minus group 2 | -0.257 | -0.346 | -0.163 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.724 | 0.638 | 0.823 | log | |
| Odds ratio, group 1 over group 2 | 0.154 | 0.0714 | 0.332 | log | |
| Number needed to treat, for one fewer participant with the outcome on MDS or CMML: IV Decitabine than on MDS or CMML: ASTX727 | 3.9 | 2.89 | 6.13 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | MDS or CMML: IV Decitabine | Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). | 89 | 132 | OG000 |
| Group 2 | MDS or CMML: ASTX727 | 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). 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. | 121 | 130 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- MDS/CMML: Number of Participants With Grade 3 or Higher TEAEs
- Description
TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. Severity of AEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.
- Time frame
- From randomization up to 30 days after last dose of study treatment (up to approximately 2.7 years)
- Population
- The Safety Analysis Set included all participants who received any amount of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML
- NCT number
- NCT03306264
- Phases
- PHASE3
- Conditions
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia
- Interventions
- ASTX727, Dacogen
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Results first posted
- 2024-07-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03306264?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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