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 @ 1:39 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT03326895
Description: None
Frequency Threshold: 1.2
Time Frame: 4 Weeks Post Procedure
Study: NCT03326895
Study Brief: A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ECHELON CIRCULAR Powered Stapler Use of the ECHELON CIRCULAR Powered Stapler 0 None 13 168 32 168 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal Stoma Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anastomotic Leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anastomotic Stenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision Site Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post Procedural Hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post-operative Ileus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stoma Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stoma Site Erythema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pelvic Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
C-reactive Protein Increased SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Oxygen Saturation Decreased SYSTEMATIC_ASSESSMENT Investigations None View