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 @ 9:30 PM
Ignite Modification Date: 2025-12-25 @ 7:16 PM
NCT ID: NCT06535932
Description: None
Frequency Threshold: 0
Time Frame: Over the one-month period that the participants were in the study (15 days per randomized mask).
Study: NCT06535932
Study Brief: Amara View Benchmark 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
Amara View Minimal Contact Full Face Mask Participants will wear the Amara View mask for 15 days Amara View Minimal Contact Full Face Mask: The Amara View Full-Face Mask is a minimal contact full face mask manufactured by Philips Respironics (Murrysville, PA) that covers the mouth and seals under the nose compared to traditional full-face masks which seal over the nose. The Amara View mask is intended to reduce discomfort on the bridge of the nose. There is no forehead arm, offering patients an enhanced design to keep the field of vision clear. 0 None 0 35 21 35 View
F40 Minimal Contact Full Face Mask Participants will wear the F40 for 15 days F40 Minimal Contact Full Face Mask: The AirFit F40 is a minimal contact FFM manufactured by ResMed (San Diego, CA) that rests softly and securely under the patients nose and is designed to let patients sleep in any position and move freely throughout the night. The mask consists of three cushion sizes and three headgear sizes. Headgear adjustments can be made with magnetic clips that easily snap on and off. 0 None 0 35 25 35 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Breathing Discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aeorophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Knee Surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View