Comparison · NCT03682536-sae
Luspatercept vs Epoetin Alfa: 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. Luspatercept vs Epoetin Alfa: serious adverse events. Trial comparisons, record NCT03682536-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03682536-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 | 0.451 | 0.38 | 0.523 | wilson | |
| Risk in group 2 | 0.397 | 0.328 | 0.47 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0539 | -0.0477 | 0.154 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.892 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.821 | 1.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Luspatercept than on Epoetin Alfa | 18.6 | 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 | Luspatercept | Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg. | 82 | 182 | EG000 |
| Group 2 | Epoetin Alfa | Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU). | 71 | 179 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality was assessed from a participants first dose to primary completion (up to approximately 221 weeks). SAEs and Other AEs were assessed from first dose to 42 days post last dose (up to approximately an average of 72 weeks and a maximum of 208 weeks).
Source ClinicalTrials.gov
Trial
- Title
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
- NCT number
- NCT03682536
- Phases
- PHASE3
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Luspatercept, Epoetin alfa
- Lead sponsor
- Celgene
- Results first posted
- 2024-06-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03682536?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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