Comparison · NCT03701308-sae
Arm I (Daunorubicin, Cytarabine) vs Arm II (Uproleselan, Daunorubicin, Cytarabine): 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. Arm I (Daunorubicin, Cytarabine) vs Arm II (Uproleselan, Daunorubicin, Cytarabine): serious adverse events. Trial comparisons, record NCT03701308-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03701308-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 | 0.0882 | 0.0512 | 0.148 | wilson | |
| Risk in group 2 | 0.0916 | 0.0532 | 0.153 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00337 | -0.0753 | 0.0676 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.963 | 0.449 | 2.07 | log | |
| Odds ratio, group 1 over group 2 | 0.96 | 0.415 | 2.22 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Daunorubicin, Cytarabine) than on Arm II (Uproleselan, Daunorubicin, Cytarabine) | 297 | 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 | Arm I (Daunorubicin, Cytarabine) | INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study. | 12 | 136 | EG000 |
| Group 2 | Arm II (Uproleselan, Daunorubicin, Cytarabine) | INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study. | 12 | 131 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were followed for 25 months and mortality was followed for 67 months.
Source ClinicalTrials.gov
Trial
- Title
- Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy
- NCT number
- NCT03701308
- Phases
- PHASE2, PHASE3
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Cytarabine, Daunorubicin, Echocardiography Test, Multigated Acquisition Scan, Uproleselan
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2026-01-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03701308?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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