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: 2025-12-25 @ 1:15 AM
Ignite Modification Date: 2025-12-25 @ 11:24 PM
NCT ID: NCT01565993
Description: None
Frequency Threshold: 4.5
Time Frame: During the endoscopic procedure
Study: NCT01565993
Study Brief: The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group B: Conventional Polipectomy In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique None None 0 39 0 39 View
Group A: Hemoclips In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop None None 1 66 3 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Perforation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures Perforation View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mucosal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Mucosal burn View