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 @ 3:49 PM
Ignite Modification Date: 2025-12-25 @ 1:56 PM
NCT ID: NCT05318092
Description: None
Frequency Threshold: 3
Time Frame: 30 days (+/- 7 days) post-procedure
Study: NCT05318092
Study Brief: Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System 0 None 18 122 9 122 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Staphylococcus test positive SYSTEMATIC_ASSESSMENT Investigations None View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Vascular access site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View