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 @ 4:35 AM
Ignite Modification Date: 2025-12-26 @ 3:37 AM
NCT ID: NCT02191618
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT02191618
Study Brief: The WEB-IT Clinical 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
CEC Adjudicated Adverse Events Through 1-Year The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant. 0 None 33 150 54 150 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cushing's syndrome SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Benign intracranial hypertension SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusional state SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
TIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoxia 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
Tracheal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vessel puncture site hematoma SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Arterial thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vessel puncture site hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders None View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders None View