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Comparison · NCT02393859-deaths

HC3 Chemotherapy vs Blinatumomab: deaths from any cause

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. HC3 Chemotherapy vs Blinatumomab: deaths from any cause. Trial comparisons, record NCT02393859-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02393859-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.4910.3660.617wilson
Risk in group 20.2040.1180.329wilson
Risk difference, group 1 minus group 20.2880.110.44newcombe hybrid score
Risk ratio, group 1 over group 22.411.344.35log
Odds ratio, group 1 over group 23.771.638.76log
Number needed to harm, for one more death from any cause on HC3 Chemotherapy than on Blinatumomab3.482.279.05from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1HC3 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).
2857EG000
Group 2BlinatumomabOne 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).1154EG001

Harm

What it counts
Total, all-cause mortality
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

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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