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Comparison · NCT01945281-sae

Caspofungin vs Amphotericin B Deoxycholate: 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. Caspofungin vs Amphotericin B Deoxycholate: serious adverse events. Trial comparisons, record NCT01945281-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01945281-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 10.2120.1070.378wilson
Risk in group 20.5630.3320.769wilson
Risk difference, group 1 minus group 2-0.35-0.582-0.0665newcombe hybrid score
Risk ratio, group 1 over group 20.3770.1720.828log
Odds ratio, group 1 over group 20.2090.05750.763log
Number needed to treat, for one fewer participant with a serious adverse event on Caspofungin than on Amphotericin B Deoxycholate2.851.7215from 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 1CaspofunginCaspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment733EG000
Group 2Amphotericin B DeoxycholateAmphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment916EG001

Harm

What it counts
Total, serious adverse events
Time frame
8 weeks after end of study therapy (up to 146 days)

Source ClinicalTrials.gov

Trial

Title
Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
NCT number
NCT01945281
Phases
PHASE2
Conditions
Candidiasis, Invasive
Interventions
Caspofungin, Amphotericin B Deoxycholate
Lead sponsor
Merck Sharp & Dohme LLC
Results first posted
2018-08-28

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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