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 @ 2:51 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT01749033
Description: None
Frequency Threshold: 5
Time Frame: 24 hours after the airway device removal
Study: NCT01749033
Study Brief: A New Insertion Technique for Laryngeal Mask Airway
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 1 Classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual. Group 1 Classic: Active Comparator: Group 1 classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual. None None 0 147 83 147 View
Group 2 Pre Inflated Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer. None None 0 145 80 145 View
Group 3 ELLIA Technique Group 3 (ELLIA): Using the ELLIA technique. Group 3 ELLIA: Group 3 (ELLIA): Using the ELLIA technique None None 0 149 78 149 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia. SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Airway complications View
Blood on OMA after removal of the OMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Airway complications View