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Comparison · NCT01922011-8ff00043

Daptomycin vs Vancomycin or Nafcillin: Number of Participants With 1 or More Adverse Events (AEs)

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. Daptomycin vs Vancomycin or Nafcillin: Number of Participants With 1 or More Adverse Events (AEs). Trial comparisons, record NCT01922011-8ff00043. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01922011-8ff00043

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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 10.4590.3510.572wilson
Risk in group 20.6250.510.728wilson
Risk difference, group 1 minus group 2-0.166-0.315-0.00417newcombe hybrid score
Risk ratio, group 1 over group 20.7350.5420.997log
Odds ratio, group 1 over group 20.510.2630.988log
Number needed to treat, for one fewer participant with the outcome on Daptomycin than on Vancomycin or Nafcillin6.043.17240from 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 1DaptomycinIV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.3474OG000
Group 2Vancomycin or NafcillinIV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h4572OG001

Outcome

Type
OTHER_PRE_SPECIFIED
Title
Number of Participants With 1 or More Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, clinically significant laboratory finding, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Time frame
Administration of first dose up to approximately six and a half months after last dose of study drug
Population
Treated participants based on the treatment received

Source ClinicalTrials.gov

Trial

Title
Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)
NCT number
NCT01922011
Phases
PHASE3
Conditions
Acute Hematogenous Osteomyelitis
Interventions
Daptomycin, Vancomycin (or equivalent), Nafcillin (or equivalent)
Lead sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Results first posted
2017-06-23

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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