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 @ 11:53 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
NCT ID: NCT03750461
Description: Interventional arm: Adverse events were collected for surgical site occurrences (surgical site infection, mesh infection, delayed wound healing), fascial dehiscence, seroma, hematoma, cellulitis or enterocutaneous fistula, or return to the operating room for mesh removal. Historical Controls: Only adverse events relating to wound or organ/space infection and wound disruption were collected.
Frequency Threshold: 0
Time Frame: From date of surgery to follow-up at approximately 2 years.
Study: NCT03750461
Study Brief: Stoma Closure and Reinforcement 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
Historical Controls Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes. 0 None 0 92 9 92 View
Intervention Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation 1 None 0 20 2 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ogilvie's syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
superficial wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
organ/space infection SYSTEMATIC_ASSESSMENT Infections and infestations None View