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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:05 AM
NCT ID: NCT01958294
Description: The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
Frequency Threshold: 0
Time Frame: 0 to 30 days following study index procedure
Study: NCT01958294
Study Brief: The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS 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
MICHI Neuroprotection System Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System. MICHI Neuroprotection System None None 2 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Procedural Complication (Transient Intolerance) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular Procedure Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood Troponin, CK or CK-MB Increased SYSTEMATIC_ASSESSMENT Investigations None View
Full Blood Count Abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Hemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Right Arm Drift SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient Ischemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemorrhage/Oozing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View