Comparison · NCT02419755-sae
Stratum 1: Myeloid Malignancies vs Stratum 2: ALL and MLM: 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. Stratum 1: Myeloid Malignancies vs Stratum 2: ALL and MLM: serious adverse events. Trial comparisons, record NCT02419755-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02419755-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 | 0.25 | 0.0456 | 0.699 | wilson | |
| Risk in group 2 | 0.333 | 0.0968 | 0.7 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0833 | -0.503 | 0.424 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.75 | 0.0975 | 5.77 | log | |
| Odds ratio, group 1 over group 2 | 0.667 | 0.0394 | 11.3 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Stratum 1: Myeloid Malignancies than on Stratum 2: ALL and MLM | 12 | 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 | Stratum 1: Myeloid Malignancies | Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description. | 1 | 4 | EG000 |
| Group 2 | Stratum 2: ALL and MLM | Participants in Stratum 2 \[Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)\] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description. | 2 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were recorded from a participant's on-study date until they were taken off study, up to 8 months. Although only 3 Stratum 1 and 4 Stratum 2 participants completed the trial, there were 4 Stratum 1 participants and 6 Stratum 2 participants evaluable for adverse events.
Source ClinicalTrials.gov
Trial
- Title
- Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies
- NCT number
- NCT02419755
- Phases
- PHASE2
- Conditions
- Mixed Lineage Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoid Leukemia
- Interventions
- Bortezomib, Vorinostat, Mitoxantrone, Cytarabine, Methotrexate, Hydrocortisone, Peg-L-Asparaginase, Erwinia L-Asparaginase, Dexamethasone, Mercaptopurine, Doxorubicin
- Lead sponsor
- St. Jude Children's Research Hospital
- Results first posted
- 2018-02-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02419755?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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GET https://conductscience.org/api/comparisons/v1/NCT02419755-sae