Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:45 PM
NCT ID: NCT02063867
Description: None
Frequency Threshold: 0
Time Frame: Intervention duration (21 months)
Study: NCT02063867
Study Brief: Active Bathing to Eliminate Infection (ABATE Infection) Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1: Usual Care Routine policy for showering or bathing non-critical care patients 0 None 0 156889 0 156889 View
Arm 2: Decolonization Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients. Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen. Arm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients. Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen. 0 None 0 183013 25 183013 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild rash on limbs NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild rash on limbs, trunk NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild rash on groin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild rash on limbs, face NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild rash on limbs, groin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild rash on limbs, trunk, face NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild rash on limbs, trunk, groin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild rash on neck, forehead NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diffuse rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diffuse itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild rash on trunk NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild rash, location unknown NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View