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 @ 5:45 PM
Ignite Modification Date: 2025-12-25 @ 3:13 PM
NCT ID: NCT02944968
Description: An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
Frequency Threshold: 0
Time Frame: Three months follow up after procedure
Study: NCT02944968
Study Brief: Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
THERMOCOOL SMARTTOUCH® SF-5D The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology 0 None 7 50 22 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V19.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V19.0 View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA V19.0 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA V19.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA V19.0 View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA V19.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA V19.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA V19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy mediastinal SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA V19.0 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA V19.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA V19.0 View
Thyroid disorder SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA V19.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA V19.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA V19.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA V19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA V19.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA V19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA V19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA V19.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA V19.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA V19.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA V19.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA V19.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA V19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA V19.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA V19.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V19.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V19.0 View
Perforation SYSTEMATIC_ASSESSMENT General disorders MedDRA V19.0 View