Comparison · NCT02604433-sae
Luspatercept + BSC vs Placebo + BSC: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Luspatercept + BSC vs Placebo + BSC: serious adverse events. Trial comparisons, record NCT02604433-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02604433-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 | 0.238 | 0.187 | 0.298 | wilson | |
| Risk in group 2 | 0.0734 | 0.0377 | 0.138 | wilson | |
| Risk difference, group 1 minus group 2 | 0.164 | 0.0817 | 0.234 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.24 | 1.6 | 6.57 | log | |
| Odds ratio, group 1 over group 2 | 3.94 | 1.8 | 8.61 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Luspatercept + BSC than on Placebo + BSC | 6.09 | 4.27 | 12.2 | 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 | Luspatercept + BSC | Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care | 53 | 223 | EG000 |
| Group 2 | Placebo + BSC | Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care | 8 | 109 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality was assessed from first dose to study completion (approximately 56 months) SAEs and NSAEs were assessed from first dose to 90 days following last dose (up to approximately 52 months)
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia
- NCT number
- NCT02604433
- Phases
- PHASE3
- Conditions
- Erythrocyte Transfusion, Beta-Thalassemia
- Interventions
- Luspatercept, Placebo
- Lead sponsor
- Celgene
- Results first posted
- 2020-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02604433?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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