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 @ 12:23 AM
Ignite Modification Date: 2025-12-25 @ 10:28 PM
NCT ID: NCT04639258
Description: The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020. Investigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported.
Study: NCT04639258
Study Brief: Medtronic Evolut™ EXPAND TAVR I Feasibility 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
TAVR Up to 75 subjects with moderate, symptomatic AS with an attempted TAVR procedure 0 None 2 11 4 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left radial artery pseudoaneurysm following study specific angiogram SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Haematome, left radial SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Parasthesia, left thumb and index finger SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Scalp laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bilateral ovarian cysts SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Saccular infrarenal abdominal aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View