Comparison · NCT03012672-sae
ARM I (HIGHER-DOSE): vs ARM II (LOWER-DOSE):: 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. ARM I (HIGHER-DOSE): vs ARM II (LOWER-DOSE):: serious adverse events. Trial comparisons, record NCT03012672-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03012672-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 | 0.45 | 0.258 | 0.658 | wilson | |
| Risk in group 2 | 0.467 | 0.302 | 0.639 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0167 | -0.274 | 0.248 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.964 | 0.52 | 1.79 | log | |
| Odds ratio, group 1 over group 2 | 0.935 | 0.3 | 2.91 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ARM I (HIGHER-DOSE): than on ARM II (LOWER-DOSE): | 60 | 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 (HIGHER-DOSE): | ARM I (HIGHER-DOSE):~INDUCTION: Patients receive granulocyte colony-stimulating factor (G-CSF) subcutaneously (SC) on days 0-5, higher dose cladribine intravenously (IV) over 2 hours on days 1-5, higher dose cytarabine IV over 2 hours on days 1-5, and higher dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 2 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. | 9 | 20 | EG000 |
| Group 2 | ARM II (LOWER-DOSE): | ARM II (LOWER-DOSE):~INDUCTION: Patients receive G-CSF SC on days 0-5, lower dose cladribine IV over 2 hours on days 1-5, lower dose cytarabine IV over 1 hour on days 1-5, and lower dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 6 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. | 14 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first.
Source ClinicalTrials.gov
Trial
- Title
- Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm
- NCT number
- NCT03012672
- Phases
- PHASE2
- Conditions
- Acute Leukemia of Ambiguous Lineage, Acute Myeloid Leukemia, Myeloid Neoplasm
- Interventions
- Cladribine, Cytarabine, Granulocyte Colony-Stimulating Factor, Mitoxantrone Hydrochloride, Quality-of-Life Assessment, Questionnaire Administration
- Lead sponsor
- University of Washington
- Results first posted
- 2021-11-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03012672?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
Read this comparison from software.
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