Comparison · NCT04266301-sae
Sabatolimab (MBG453) + Azacitidine vs Placebo + Azacitidine: serious adverse events
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. Sabatolimab (MBG453) + Azacitidine vs Placebo + Azacitidine: serious adverse events. Trial comparisons, record NCT04266301-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04266301-sae
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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 | 0.662 | 0.602 | 0.716 | wilson | |
| Risk in group 2 | 0.619 | 0.559 | 0.675 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0427 | -0.039 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.941 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.843 | 1.72 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sabatolimab (MBG453) + Azacitidine than on Placebo + Azacitidine | 23.4 | from the risk difference interval | the interval includes no difference |
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 | Sabatolimab (MBG453) + Azacitidine | Participants received sabatolimab plus Azacitidine | 174 | 263 | EG000 |
| Group 2 | Placebo + Azacitidine | Participants received placebo plus Azacitidine | 164 | 265 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 43.5 months (sabatolimab plus AZA) and 42.6 months (placebo + AZA). Deaths were collected from randomization until end of trial, approx. 52 months.
Source ClinicalTrials.gov
Trial
- Title
Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
- NCT number
- NCT04266301
- Phases
- PHASE3
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
- Interventions
- Sabatolimab, Azacitidine, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2025-12-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04266301?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT04266301-sae