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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:22 AM
NCT ID: NCT04858802
Description: A standard questionnaire was used to determine whether or not adverse events (AE) had occurred at the current follow-up visit or since the previous follow-up visit. Clinical investigators evaluated the occurrence of AEs excluding usual post-operative recovery signs and symptoms experienced by participants, unless corroborated by objective findings and/or requiring specific medical or therapeutic interventions.
Frequency Threshold: 5
Time Frame: From enrollment through Day 180 (end of study)
Study: NCT04858802
Study Brief: A Clinical Evaluation of PROPEL® Contour Sinus Implant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PROPEL Contour Sinus Implant All sinuses exposed to the PROPEL Contour Sinus Implant 0 None 1 80 15 80 View
Balloon Sinus Dilation Alone All sinuses that were not exposed to the PROPEL Contour Sinus Implant. 0 None 1 80 16 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Loss of balance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chronic sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View