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 @ 3:42 PM
Ignite Modification Date: 2025-12-25 @ 1:51 PM
NCT ID: NCT01793792
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01793792
Study Brief: Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Device: LVIS LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. 6 None 48 153 15 153 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dissection or perforation of the parent artery SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aneurysm rupture SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intra-Parenchymal Hemorrhage (IPH) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological deficits SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stent Thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sub-Arachnoid Hemorrhage (SAH) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sub-Dural Hematoma (SDH) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
TIA (Transient Ischemic Attack) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Target aneurysm retreatment SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vasospasm SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View