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 @ 3:53 PM
Ignite Modification Date: 2025-12-25 @ 1:58 PM
NCT ID: NCT01186692
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT01186692
Study Brief: Melody® Transcatheter Pulmonary Valve Post-Approval 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
Catheterized Cohort The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV. None None 52 120 31 120 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemias NEC SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Haematological disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac disorders NEC SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disorders NEC SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary valvular disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rate and rhythm disorders NEC SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular arrhythmias SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular arrhythmias and cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal disorders NEC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea and vomiting symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhoea (excl infective) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Device issues NEC SYSTEMATIC_ASSESSMENT General disorders None View
Device physical property and chemical issues SYSTEMATIC_ASSESSMENT General disorders None View
Febrile disorders SYSTEMATIC_ASSESSMENT General disorders None View
Therapeutic and nontherapeutic responses SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract and lung infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis, bacteraemia, viraemia and fungaemia NEC SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac and vascular procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Non-site specific procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nervous system disorders NEC SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological signs and symptoms NEC SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumothorax and pleural effusions NEC SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary thrombotic and embolic conditions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory tract disorders NEC SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-site specific embolism and thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular injuries NEC SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain and discomfort NEC SYSTEMATIC_ASSESSMENT General disorders None View
Therapeutic and nontherapeutic responses SYSTEMATIC_ASSESSMENT General disorders None View
Infections NEC SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non-site specific procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View