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Comparison · NCT00260832-sae

Cytarabine or Supportive Care vs Dacogen (Decitabine) Only: 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. Cytarabine or Supportive Care vs Dacogen (Decitabine) Only: serious adverse events. Trial comparisons, record NCT00260832-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00260832-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 10.6840.6220.739wilson
Risk in group 20.7980.7430.844wilson
Risk difference, group 1 minus group 2-0.115-0.192-0.036newcombe hybrid score
Risk ratio, group 1 over group 20.8560.7690.954log
Odds ratio, group 1 over group 20.5460.3590.829log
Number needed to treat, for one fewer participant with a serious adverse event on Cytarabine or Supportive Care than on Dacogen (Decitabine) Only8.715.2127.8from 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 1Cytarabine or Supportive Care
Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
162237EG000
Group 2Dacogen (Decitabine) Only20 mg/m\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.190238EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Trial of Decitabine in Patients With Acute Myeloid Leukemia
NCT number
NCT00260832
Phases
PHASE3
Conditions
Acute Myeloid Leukemia
Interventions
Cytarabine or Supportive Care, Dacogen (decitabine) only
Lead sponsor
Eisai Inc.
Results first posted
2011-09-21

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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