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Comparison · NCT01597973-deaths

Colistin and Placebo vs Colistin and a Carbapenem: 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. Colistin and Placebo vs Colistin and a Carbapenem: deaths from any cause. Trial comparisons, record NCT01597973-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01597973-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 10.4260.3640.491wilson
Risk in group 20.3730.3130.437wilson
Risk difference, group 1 minus group 20.0533-0.03620.142newcombe hybrid score
Risk ratio, group 1 over group 21.140.9121.43log
Odds ratio, group 1 over group 21.250.8591.82log
Number needed to harm, for one more death from any cause on Colistin and Placebo than on Colistin and a Carbapenem18.8from 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 1Colistin and Placebocolistin and placebo: colistin- loading dose standard, maintenance dosed based on patient's renal function placebo- mimic meropenem (blinded)98230EG000
Group 2Colistin and a Carbapenemcolistin and carbapenem: colistin standard loading dose, maintenance dose based on patient's renal function carbapenem- dose based on patient's renal function85228EG001

Harm

What it counts
Total, all-cause mortality
Time frame
For AEs, the assessment period begins at the time of enrollment and continues until 48 hours after end of treatment, that is up to 16 days. (as 48 hours is total removal of colistin from the patient has occurred). All-Cause Mortality, the Primary Objective is assessed up to 30 days after enrollment.

Source ClinicalTrials.gov

Trial

Title
Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)
NCT number
NCT01597973
Phases
PHASE3
Conditions
Pneumonia, Blood Stream Infection
Interventions
colistin and meropenem, colistin and placebo
Lead sponsor
University of Michigan
Results first posted
2021-11-30

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.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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