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: 2025-12-24 @ 12:35 PM
Ignite Modification Date: 2025-12-25 @ 12:11 PM
NCT ID: NCT00334061
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00334061
Study Brief: Study to Assess the Safety and Effectiveness of the Penumbra System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Penumbra System None None None 65 125 125 125 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebral Edema None Nervous system disorders None View
Intracerebral Hemorrhage None Nervous system disorders None View
Respiratory Dysfunction/Failure None Respiratory, thoracic and mediastinal disorders None View
Worsening Symptoms of Qualifying Stroke None Nervous system disorders None View
Infection None General disorders None View
Other Pulmonary Complications None Respiratory, thoracic and mediastinal disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Cardiac Arrhythmia None Cardiac disorders None View
Myocardial Infarction None Cardiac disorders None View
Peripheral Vascular Complication None Vascular disorders None View
Renal Dysfunction/Failure None Renal and urinary disorders None View
Stroke in New Territory None Nervous system disorders None View
Access Site Complication None Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Electrolyte Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Pulmonary Complications SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Coagulopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hepato-Biliary Dysfunction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Peripheral Edema SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Worsening Symptoms of Qualifying Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphasia-Aspiration SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cardiac Complications SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Ulcer SYSTEMATIC_ASSESSMENT General disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cerebral Edema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral Vascular Complication SYSTEMATIC_ASSESSMENT Vascular disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal Dysfunction/Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Embolization of Previously Uninvolved Vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View