Comparison · NCT02393859-sae
HC3 Chemotherapy vs Blinatumomab: 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. HC3 Chemotherapy vs Blinatumomab: serious adverse events. Trial comparisons, record NCT02393859-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02393859-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 | 0.462 | 0.333 | 0.595 | wilson | |
| Risk in group 2 | 0.278 | 0.176 | 0.409 | wilson | |
| Risk difference, group 1 minus group 2 | 0.184 | 0.000424 | 0.351 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.66 | 0.987 | 2.8 | log | |
| Odds ratio, group 1 over group 2 | 2.23 | 0.994 | 5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on HC3 Chemotherapy than on Blinatumomab | 5.44 | 2.85 | 2,360 | 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 | HC3 Chemotherapy | One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses). | 24 | 52 | EG000 |
| Group 2 | Blinatumomab | One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI). | 15 | 54 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality is reported from randomization through the end of study; the median overall follow-up time was 55.2 months. Treatment-emergent adverse events are reported from the first dose of IP through the last dose of IP (up to Day 29) plus 30 days.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)
- NCT number
- NCT02393859
- Phases
- PHASE3
- Conditions
- Leukemia, Acute Lymphoblastic
- Interventions
- Blinatumomab, Dexamethasone, Vincrisitne, Daunorubicin, Methotrexate, Ifosfamide, PEG-asparaginase, Erwinia-asparaginase
- Lead sponsor
- Amgen
- Results first posted
- 2020-07-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02393859?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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