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: 2025-12-25 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:52 PM
NCT ID: NCT01105767
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01105767
Study Brief: Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 Standard Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants. None None 0 9315 0 9315 View
Group 2 Enhanced Standard Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care. None None 0 10864 0 10864 View
Group 3 Chlorhexidine Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use. None None 0 10030 4 10030 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dermatitis due to soap SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View