Comparison · NCT03733249-sae
Rivogenlecleucel (BPX-501) Safety Population vs Rimiducid Safety Population: 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. Rivogenlecleucel (BPX-501) Safety Population vs Rimiducid Safety Population: serious adverse events. Trial comparisons, record NCT03733249-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03733249-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 | 0.304 | 0.24 | 0.377 | wilson | |
| Risk in group 2 | 0.438 | 0.231 | 0.668 | wilson | |
| Risk difference, group 1 minus group 2 | -0.133 | -0.373 | 0.0855 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.695 | 0.381 | 1.27 | log | |
| Odds ratio, group 1 over group 2 | 0.562 | 0.199 | 1.59 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rivogenlecleucel (BPX-501) Safety Population than on Rimiducid Safety Population | 7.5 | 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 | Rivogenlecleucel (BPX-501) Safety Population | All patients who received HSCT and went on to receive any dose of rivogenlecleucel. | 52 | 171 | EG000 |
| Group 2 | Rimiducid Safety Population | All patients who received at least 1 dose of rimiducid for the treatment of acute or chronic GvHD refractory to SoC treatment after rivogenlecleucel administration. | 7 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Source ClinicalTrials.gov
Trial
- Title
- Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study
- NCT number
- NCT03733249
- Phases
- PHASE1, PHASE2
- Conditions
Acute Lymphoblastic Leukemia, Leukemia, Acute Myeloid (AML), Child, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Primary Immunodeficiency, Anemia, Aplastic, Hemoglobinopathies, Cytopenia, Fanconi Anemia, Diamond Blackfan Anemia, Thalassemia, Anemia, Sickle Cell
- Interventions
- Rimiducid, rivogenlecleucel
- Lead sponsor
- Bellicum Pharmaceuticals
- Results first posted
- 2023-09-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03733249?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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