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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT03218566
Description: None
Frequency Threshold: 0
Time Frame: Within 30 days post-procedure
Study: NCT03218566
Study Brief: Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism 3 None 13 119 56 119 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardio-respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vascular Access Site Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ovarian Cancer Metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke in Evolution SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abnormal Faeces SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Crohn's Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hernia SYSTEMATIC_ASSESSMENT General disorders None View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Vessel Puncture Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alcohol Poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road Traffic Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular Pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest wall haematoma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Groin Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Limb Discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unresponsive To Stimuli SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypercapnia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Infarction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sputum Discoloured SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vascular Access Site Hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View