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 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:19 PM
NCT ID: NCT03876457
Description: None
Frequency Threshold: 0
Time Frame: 90 days
Study: NCT03876457
Study Brief: SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Endovascular Thrombectomy Plus Medical Management Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols. 68 None 129 178 77 178 View
Medical Management Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients. 71 None 123 174 59 174 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Access Site Complication - Arterial Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Access Site Complication - Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Access Site Complication - Infection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute Arterial Occlusion (Acute Limb Ischemia) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cerebral Edema with Midline Shift SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebritis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Delirium, Cognitive Dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Endocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperglycemic Hyperosmolar State SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Lower respiratory infection (pneumonia) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Neurological Deterioration SYSTEMATIC_ASSESSMENT Nervous system disorders None View
New Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Progression of Disease, Palliative Care Decision SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Sepsis, Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Symptomatic Intracranial Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Wound Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alcohol Withdrawal SYSTEMATIC_ASSESSMENT General disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Asymptomatic Intracranial Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cardiac Arrythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Carotid Cavernous Fistula SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral Vasospasm SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Clonus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diaphoresis SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Evolution of infarction on the brain imaging SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Eye Complications SYSTEMATIC_ASSESSMENT Eye disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal Complications SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hallucination SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Lactose intolerance reaction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Laryngeal Edema SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT General disorders None View
Liver Injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Musculoskeletal Complications SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
near syncopal episode SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-Cerebral Thrombotic Events SYSTEMATIC_ASSESSMENT Vascular disorders None View
ocular nerve damage SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Renal Complications SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Progression of Disease SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SDH SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin Complications SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Splenic infarct SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Stent Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Symptomatic Carotid Artery Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syndrome of inappropriate ADH production SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Thirst SYSTEMATIC_ASSESSMENT General disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tremors SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Uterine hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vessel dissection SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vessel perforation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Epidural Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View