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 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT05288556
Description: If the Principal Investigator, or his/her designee concludes the study accessory is malfunctioning, inadvertently removed or compromised or, for any reason, determined to be a greater risk than benefit, e.g., the patient has an allergic reaction, and is replaced by a commercially available accessory, the patient will be exited from the study by early termination.
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT05288556
Study Brief: Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stoma Site Accessory Stoma site accessory with enteral tube replacement procedure. Placement of stoma site enteral feeding tube accessory: The study stoma site accessory will be attached at the stoma site during an enteral tube replacement procedure the patient is scheduled to have as a standard of care procedure. The study stoma site accessory is compatible with commercially available enteral nutrition feeding tubes ranging from size 16 to 20 French tubing that are adjustable to variable length. 0 None 1 5 3 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Protocol View
Hospitalization SYSTEMATIC_ASSESSMENT General disorders Protocol View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Inadvertent removal of tubing prior to month 6 SYSTEMATIC_ASSESSMENT Nervous system disorders Protocol View
Inadvertent removal of tubing prior to month 6 SYSTEMATIC_ASSESSMENT Social circumstances Protocol View
Surgical removal of embedded accessory prior to month 6 SYSTEMATIC_ASSESSMENT Surgical and medical procedures Protocol View
Increased leakage due to migrating bumper SYSTEMATIC_ASSESSMENT Product Issues Protocol View