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 @ 11:42 PM
Ignite Modification Date: 2025-12-25 @ 9:33 PM
NCT ID: NCT03064451
Description: The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Frequency Threshold: 5
Time Frame: Up to 12 months
Study: NCT03064451
Study Brief: Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Participants With Persistent Atrial Fibrillation (PsAF) Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure. 0 None 10 52 6 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 17.1 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 17.1 View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 17.1 View
Arteriovenous fistula NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 17.1 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 17.1 View
Coronary artery occlusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 17.1 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 17.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 17.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 17.1 View
Periprosthetic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 17.1 View
Arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 17.1 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 17.1 View