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Comparison · NCT01060072-sae

Loteprednol Etabonate vs Vehicle: 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. Loteprednol Etabonate vs Vehicle: serious adverse events. Trial comparisons, record NCT01060072-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01060072-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 10.01460.004960.0419wilson
Risk in group 20.004980.0008790.0276wilson
Risk difference, group 1 minus group 20.00959-0.0150.0373newcombe hybrid score
Risk ratio, group 1 over group 22.930.30727.9log
Odds ratio, group 1 over group 22.960.30528.7log
Number needed to harm, for one more participant with a serious adverse event on Loteprednol Etabonate than on Vehicle104from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: vehicle.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Loteprednol EtabonateLoteprednol etabonate 0.5% ophthalmic suspension3206EG000
Group 2VehicleVehicle of loteprednol etabonate ophthalmic suspension.1201EG001

Harm

What it counts
Total, serious adverse events
Time frame
14 Days

Source ClinicalTrials.gov

Trial

Title
Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
NCT number
NCT01060072
Phases
PHASE3
Conditions
Inflammation, Pain
Interventions
Loteprednol etabonate, Vehicle of Loteprednol Etabonate
Lead sponsor
Bausch & Lomb Incorporated
Results first posted
2012-01-13

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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