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 @ 12:21 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT03022461
Description: An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Frequency Threshold: 0
Time Frame: Events were collected as of 2 to 5 Years follow-up post implant
Study: NCT03022461
Study Brief: HeartMate 3 CE Mark Study Long Term Follow-up
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ongoing HM3 CE Mark Study Patients Ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection. 3 None 13 25 0 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pump Thrombosis SYSTEMATIC_ASSESSMENT Product Issues None View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke, Hemorrhagic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke, Ischemic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal Dysfunction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Outflow Graft Thrombosis SYSTEMATIC_ASSESSMENT Product Issues None View
Other Neurological event SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pump Malfunction SYSTEMATIC_ASSESSMENT Product Issues None View
Psychiatric Episode SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hepatic Dysfunction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pericardial Fluid Collection SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Adverse Event SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):