Adverse Events Module

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 @ 12:55 PM
Ignite Modification Date: 2025-12-25 @ 12:18 PM
NCT ID: NCT02186561
Description: The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Frequency Threshold: 0
Time Frame: Adverse Events were collected from the point of consent through year 3
Study: NCT02186561
Study Brief: Prospective Study on Embolization of Intracranial Aneurysms With Pipelineā„¢ Embolization Device
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 Participants who received the Investigational Device followed through 1 Year 1 None 39 141 107 141 View
CEC Adjudicated Adverse Events Through 2-Year Participants who received the Investigational Device followed through 2 Year 1 None 49 141 112 141 View
CEC Adjudicated Adverse Events Through 3-Year Participants who received the Investigational Device followed through 3 Year 2 None 60 141 112 141 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (17.0) View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.0) View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.0) View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.0) View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.0) View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Thrombosis in Device SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.0) View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.0) View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (17.0) View
Colonic abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Patella Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Procedural hypertension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Vascular Graft Occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.0) View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
Compartment syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.0) View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.0) View
Carotid Artery Dissection SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Cerebral Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Myasthenia Gravis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.0) View
Renal failure chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.0) View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Ovarian cyst ruptured SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.0) View
Stevens-Johnson Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (17.0) View
Aneurysm repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (17.0) View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Vascular Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Lymphatic Disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (17.0) View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.0) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Gastritis Erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Bronchopulmonary Aspergillosis Allergic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Tibia Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.0) View
Loss of Consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Ovarian Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.0) View
Coronary Arterial Stent Insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (17.0) View
Intervertebral Disc Operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (17.0) View
Medical Device Removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (17.0) View
Malignant Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Vascular Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haemorrhagic Diathesis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (17.0) View
Lymphoid tissue hyperplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (17.0) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (17.0) View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (17.0) View
Amaurosis Fugax SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Conjunctival Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Gastrointestinal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Catheter site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Periorbital Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.0) View
Hypervolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.0) View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.0) View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
Spinal Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Cerebral vasoconstriction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Intracranial Artery Dissection SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Ischaemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Muscle spasticity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Radiculitis Lumbosacral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Sensory Disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Subarachnoid Heamorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Visual field defect SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Dysphemia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.0) View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (17.0) View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (17.0) View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (17.0) View
Swelling Face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (17.0) View
Arterial stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Vasospasm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Catheter Site Injury SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Modified Rankin Score Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (17.0) View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.0) View
Cognitive Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Monoplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.0) View