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 @ 11:52 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
NCT ID: NCT01397461
Description: The safety population was defined as all patients who had at least one application of study drug. One patient was randomised to retapamulin but treated with ozenoxacin. One patient was randomised to retapamulin but not treated.
Frequency Threshold: 3
Time Frame: AEs were elicited from signing the informed consent to the completion of the clinical study (including the Final Visit) or premature patient withdrawal from the study (10-13 days)
Study: NCT01397461
Study Brief: Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ozenoxacin Placebo cream ozenoxacin placebo: cream None None 0 156 0 156 View
Ozenoxacin 1% Cream 1% cream ozenoxacin 1% cream: 1% cream None None 0 156 0 156 View
Retapamulin 1% Ointment 1% ointment retapamulin 1% ointment: ointment None None 0 152 0 152 View
Serious Events(If Any):
Other Events(If Any):