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: 2025-12-24 @ 5:33 PM
Ignite Modification Date: 2025-12-25 @ 3:05 PM
NCT ID: NCT01286168
Description: All subjects underwent a mandatory follow-up visit approximately one week after surgery, at which time surgical sites are evaluated and appropriate study cultures obtained. Additional visits were made for clinical care; follow up phone calls were also made to the subjects.
Frequency Threshold: 0
Time Frame: Eligible subjects were recruited prospectively from the breast surgical practices between May 2011 and June 2013.
Study: NCT01286168
Study Brief: Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Antisepsis Side A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day. Sodium hypochlorite (Dakin's Solution): 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day Chlorhexidine gluconate disk: Apply one chlorhexidine disk to the intervention drain site(s) and change every three days Occlusive Adhesive Dressing: A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. None None 0 104 3 104 View
Control Side Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care. Control: Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care. None None 0 104 6 104 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Surgical Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View