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: 2025-12-26 @ 10:16 PM
Ignite Modification Date: 2025-12-26 @ 10:16 PM
NCT ID: NCT02401412
Description: Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT02401412
Study Brief: The Advocate Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Ostomy Barrier The test product is a new Hollister ostomy barrier. Test Ostomy Barrier 2 None 12 79 6 79 View
Control Ostomy Barrier The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier 0 None 6 74 11 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death due to septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pelvic Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Intestinal Blockage/Illeus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Death due to primary cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inflamed gall bladder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-specific Failure to Thrive SYSTEMATIC_ASSESSMENT General disorders None View
Non-specific Pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elective colonoscopy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Incisional Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intestinal Blockage/Illeus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stoma abrasion caused by patient SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ostomy pouching system not secure SYSTEMATIC_ASSESSMENT Product Issues None View
Peristomal Skin Complication SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Stoma complication SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View