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 @ 3:19 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT01997905
Description: None
Frequency Threshold: 0
Time Frame: Incidence of Serious Adverse Events reported during the study
Study: NCT01997905
Study Brief: Stroke Feasibility 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
AtriClip LAA Exclusion Device AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device None None 5 10 8 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pnemonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Carinoid tumor pulmonary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Radius Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Biopsy Lung Abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Troponin Increased SYSTEMATIC_ASSESSMENT Investigations None View
Electrolyte Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Carinoid Tumor Pulmonary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Altered State of Consciousness SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diabetic Nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cataract Operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiovascular Deconditioning SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diastolic Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sick Sinus Sundrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accident at Home SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiatory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View