Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:05 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT00705159
Description: Safety population
Frequency Threshold: 5
Time Frame: 15 days
Study: NCT00705159
Study Brief: Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Loteprednol Etabonate Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID). None None 2 35 2 35 View
Tobramycin Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID). None None 2 34 2 34 View
Vehicle Vehicle of Zylet. One or two drops in study eye four times a day (QID). None None 1 33 2 33 View
Loteprednol Etabonate and Tobramycin Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID). None None 2 34 2 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory distress SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra View