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Comparison · NCT01345929-sae

CXA-201 as Treatment for cUTI vs Levofloxacin as Treatment for cUTI: 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. CXA-201 as Treatment for cUTI vs Levofloxacin as Treatment for cUTI: serious adverse events. Trial comparisons, record NCT01345929-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01345929-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 10.02810.01710.0459wilson
Risk in group 20.03360.02140.0526wilson
Risk difference, group 1 minus group 2-0.0055-0.02740.0161newcombe hybrid score
Risk ratio, group 1 over group 20.8360.4261.64log
Odds ratio, group 1 over group 20.8320.4151.67log
Number needed to treat, for one fewer participant with a serious adverse event on CXA-201 as Treatment for cUTI than on Levofloxacin as Treatment for cUTI182from 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 1CXA-201 as Treatment for cUTICXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days15533EG000
Group 2Levofloxacin as Treatment for cUTILevofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days18535EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis
NCT number
NCT01345929
Phases
PHASE3
Conditions
Complicated Urinary Tract Infection, Pyelonephritis
Interventions
CXA-201, Levofloxacin
Lead sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Results first posted
2015-01-15

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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