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Comparison · NCT04023526-sae

Cusatuzumab 10 mg/kg Plus Azacitdine vs Cusatuzumab 20 mg/kg Plus Azacitidine: 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. Cusatuzumab 10 mg/kg Plus Azacitdine vs Cusatuzumab 20 mg/kg Plus Azacitidine: serious adverse events. Trial comparisons, record NCT04023526-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04023526-sae

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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 10.8630.7430.932wilson
Risk in group 20.7840.6540.875wilson
Risk difference, group 1 minus group 20.0784-0.0720.226newcombe hybrid score
Risk ratio, group 1 over group 21.10.9181.32log
Odds ratio, group 1 over group 21.730.6114.89log
Number needed to harm, for one more participant with a serious adverse event on Cusatuzumab 10 mg/kg Plus Azacitdine than on Cusatuzumab 20 mg/kg Plus Azacitidine12.7from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Cusatuzumab 10 mg/kg Plus Azacitdine
Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.~.
4451EG000
Group 2Cusatuzumab 20 mg/kg Plus AzacitidineParticipants will receive azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.4051EG001

Harm

What it counts
Total, serious adverse events
Time frame
From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months)

Source ClinicalTrials.gov

Trial

Title
A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
NCT number
NCT04023526
Phases
PHASE2
Conditions
Leukemia, Myeloid, Acute
Interventions
Azacitidine, Cusatuzumab
Lead sponsor
OncoVerity, Inc.
Results first posted
2024-07-30

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.govNone 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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