Comparison · NCT04313881-sae
Magrolimab + 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. Magrolimab + Azacitidine vs Placebo + Azacitidine: serious adverse events. Trial comparisons, record NCT04313881-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04313881-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 | 0.719 | 0.661 | 0.77 | wilson | |
| Risk in group 2 | 0.515 | 0.455 | 0.575 | wilson | |
| Risk difference, group 1 minus group 2 | 0.203 | 0.121 | 0.282 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.39 | 1.21 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 2.4 | 1.68 | 3.45 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Magrolimab + Azacitidine than on Placebo + Azacitidine | 4.91 | 3.54 | 8.27 | 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 | Magrolimab + Azacitidine | Participants received the following magrolimab and azacitidine dosing regimens:~Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter.~Azacitidine 75 mg/m\^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle.~The maximum duration of treatment was up to approximately 2.6 years. | 189 | 263 | EG000 |
| Group 2 | Placebo + Azacitidine | Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine:~Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter.~Azacitidine 75 mg/m\^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle.~The maximum duration of treatment was up to approximately 2.5 years. | 136 | 264 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 135.9 weeks plus 70 days (Up to 2.8 years)
Source ClinicalTrials.gov
Trial
- Title
- Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
- NCT number
- NCT04313881
- Phases
- PHASE3
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Magrolimab, Azacitidine, Placebo
- Lead sponsor
- Gilead Sciences
- Results first posted
- 2024-03-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04313881?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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