Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:35 AM
Ignite Modification Date: 2025-12-25 @ 10:44 PM
NCT ID: NCT01270867
Description: A study specific AE classification system was used to categorize Site Reported AEs and SAEs. The study used an independent clinical events committee, CT and MRI imaging core laboratory, a separate angiography core laboratory, and an independent data safety and monitoring board (DSMB) to ensure appropriate oversight and analysis.
Frequency Threshold: 5
Time Frame: Each subject was followed for 90 days; The study period was 1 year.
Study: NCT01270867
Study Brief: Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever 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
Merci Retriever Patients who were randomized to receive the Merci Retriever. None None 39 90 73 90 View
Trevo Stentriever Patients who were randomized to receive the Trevo Stentriever. None None 41 88 71 88 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
New Ischemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Late ICH SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Access Site Complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Acute Mental Status Change/Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral Edema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia (Difficulty Swallowing) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient Ischemic Attack (TIA) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
IVH SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SAH SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ICH - HI -1 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ICH - HI -2 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ICH - PH1 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ICH - PH2 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurologic Decline SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Progression of index Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Reocclusion at the site of original occlusion or proximal to original occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Seizure - New Onset SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unresponsiveness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arrhythmia - Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiopulmonary Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension - Sustained - Tx SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stress Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Occult Blood SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Electrolyte Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Joint/Extremity Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intramural Arterial Dissection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hemoptysis (bloody sputum) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Emboli SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure - Acute SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep Vein Thrombosis (DVT) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Drug Reaction SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Positive Cultures SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Events With an Outcome of Death SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cerebral Edema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia (Difficulty Swallowing) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SAH SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ICH - HI -1 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ICH - PH1 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurologic Decline SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arrhythmia - Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea and Vomiting (Non-Neuro) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Electrolyte Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Joint/Extremity Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure - Acute SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep Vein Thrombosis (DVT) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Positive Cultures SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View