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 @ 3:48 AM
Ignite Modification Date: 2025-12-26 @ 2:35 AM
NCT ID: NCT03330002
Description: None
Frequency Threshold: 5
Time Frame: Approximately 30 days after deployment of the MANTA device
Study: NCT03330002
Study Brief: MANTA Registry for Vascular Large-bore Closure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MANTA Vascular Closure Device (VCD) MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices. 7 None 110 500 98 500 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paravalvular aortic regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Device embolisation SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular access site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site bleeding-oozing SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular procedure complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lead dislodgement SYSTEMATIC_ASSESSMENT Product Issues None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac pacemaker insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Iliac artery perforation SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral artery dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vessel perforation SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vascular access site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View