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 @ 3:44 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT03733392
Description: An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT03733392
Study Brief: Advisor HD Grid Observational 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
PersAF Subjects Enrolled subjects who provided written informed consent, confirmed to meet all inclusion criteria and none of the exclusion criteria, indicated for cardiac electroanatomical mapping and RF ablation procedure to treat persistent atrial fibrillation, and in which the HD Grid catheter was inserted and RF ablation procedure performed. 1 None 39 334 10 334 View
VT Subjects Enrolled subjects who provided written informed consent, confirmed to meet all inclusion criteria and none of the exclusion criteria, indicated for cardiac electroanatomical mapping and RF ablation procedure to treat sustained monomorphic ventricular tachycardia, and in which the HD Grid catheter was inserted and RF ablation procedure performed. 0 None 11 38 0 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ARRHYTHMIA PRE-EXISTING NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RESPIRATORY COMPROMISE/DECOMPENSATION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CHEST PAIN/ANGINA (CARDIAC) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
INCOMPLETE AV, SINUS NODE, OR OTHER HEART BLOCK NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
MYOCARDIAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PAIN (NON-CARDIAC) NON_SYSTEMATIC_ASSESSMENT General disorders None View
PALPITATION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY EDEMA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
VASCULAR ACCESS COMPLICATIONS NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
ARM WEAKNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CHRONOTROPIC INCOMPETENCE NON_SYSTEMATIC_ASSESSMENT General disorders None View
ARRHYTHMIA NEW NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
PERICARDIAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PULMONARY EMBOLISM NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
THROMBOSIS/THROMBUS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
TRANSIENT ISCHEMIC ATTACK (TIA) NON_SYSTEMATIC_ASSESSMENT General disorders None View
BLEEDING/ANEMIA NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
CARDIAC ARREST NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CEREBROVASCULAR ACCIDENT/ STROKE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
CORONARY ARTERY THROMBOSIS/OCCLUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
EMBOLIC EVENT NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
HEART FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HYPOXIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY VEIN STENOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
VASCULAR BLEEDING/LOCAL HEMATOMAS/ECCHYMOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
PREAUTOMATIC PAUSE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC PERFORATION OR TAMPONADE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ARTERIOVENOUS FISTULA NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
BLURRED VISION NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
SHORT TERM LAPSES IN MEMORY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PAIN (NON-CARDIAC) NON_SYSTEMATIC_ASSESSMENT General disorders None View
PERICARDIAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SKIN BURNS/DERMATITIS/ERYTHEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
VASCULAR ACCESS COMPLICATIONS NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
PAIN (NON-CARDIAC) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View