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 @ 2:29 AM

Ignite Modification Date: 2025-12-26 @ 1:04 AM

NCT ID: NCT03033134

Description: Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.

Frequency Threshold: 5

Time Frame: 2 years

Study: NCT03033134

Study Brief: A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Roll-in	Roll-in cohort: 12 subjects	1	None	6	12	11	12	View
Implant (ITT)	Implant (ITT) group: 42 subjects	1	None	13	42	31	42	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Dyspnea - Heart Failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	Internal difinitions	View
Renal	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	Internal difinitions	View
Device Thrombus Atrial Facing - Post Procedure	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	Internal difinitions	View
Endocrine	SYSTEMATIC_ASSESSMENT	Endocrine disorders	Internal difinitions	View
Major Bleed Requiring Transfusion	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	Internal difinitions	View
Stroke (Ischemic)	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Internal difinitions	View
Gastrointestinal Bleeding	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Internal difinitions	View
Pericarditis - Unrelated (Non Study) Procedure Or Device	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Sinus Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Coronary Artery Disease	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Multiple Heart Failure Symptoms	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Anemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	Internal difinitions	View
Cardiac Arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Chest Pain - Other	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Cranial Bleed - Without Stroke	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Internal difinitions	View
Dizziness	SYSTEMATIC_ASSESSMENT	General disorders	Internal difinitions	View
Head, Eyes, Ears, Norse, Throat (HEENT)	SYSTEMATIC_ASSESSMENT	General disorders	Internal difinitions	View
Heart Failure Symptoms - Unspecified	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Hematoma	SYSTEMATIC_ASSESSMENT	Vascular disorders	Internal difinitions	View
Led to Death	SYSTEMATIC_ASSESSMENT	General disorders	Internal difinitions	View
Sinus Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Systemic Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	Internal difinitions	View
Torsades Des Pointes	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Transient Ischemic Attack (TIA)	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Internal difinitions	View
Vetricular Tachycardia (VT) / Monomorphic VT	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Chest Pain - Heart Failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Internal difinitions	View
Death	SYSTEMATIC_ASSESSMENT	General disorders	Internal difinitions	View
Gastrointestinal	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Internal difinitions	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Head, Eyes, Ears, Nose, Throat (Heent)	SYSTEMATIC_ASSESSMENT	General disorders	Internal difinitions	View
Gastrointestinal	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Internal difinitions	View
Integumentary	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	Internal difinitions	View
Pulmonary	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	Internal difinitions	View
Neurological	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Internal difinitions	View
Abnormal Laboratory Values	SYSTEMATIC_ASSESSMENT	Investigations	Internal difinitions	View
Endocrine	SYSTEMATIC_ASSESSMENT	Endocrine disorders	Internal difinitions	View
Musculoskeletal	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	Internal difinitions	View
Fever and/or Virus	SYSTEMATIC_ASSESSMENT	Infections and infestations	Internal difinitions	View