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 @ 9:26 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
NCT ID: NCT03185832
Description: All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Frequency Threshold: 0
Time Frame: Adverse events are collected through study completion, an average of 20 months
Study: NCT03185832
Study Brief: Heart Failure and Sudden Cardiac Death Japan Registry
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Actively Enrolled Patients Patients actively enrolled in the study, defined as subjects who met all eligibility criteria and who signed informed consent 39 None 172 354 99 354 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection (> 30 days post implant) SYSTEMATIC_ASSESSMENT Product Issues None View
Hematoma- Pocket (>30 days post implant) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elevated Threshold - RV Lead SYSTEMATIC_ASSESSMENT Product Issues None View
Elevated Threshold - LV Lead SYSTEMATIC_ASSESSMENT Product Issues None View
Post-surgical pocket hemorrhage/bleeding/drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Post -Surgical infection (<= 30 days post implant) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hematoma - pocket (<= 30 days post-implant) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Syncope - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral edema - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fatigue - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal Failure/Insufficiency - Heart Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dehydration - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Weight Gain - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pleural Effusion - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Medication Complication - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure Symptoms - Unspecified SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multiple Heart Failure Symptoms SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other - Heart failure patient condition SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Fibrillation (VF) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Tachycardia (VT)/Monomorphic VT SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nonsustained ventricular tachycardia (NSVT) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Head, eyes, ears, nose, throat (HEENT) SYSTEMATIC_ASSESSMENT General disorders None View
Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Incisional/Superficial Infection (<= 30d post implant without explant) SYSTEMATIC_ASSESSMENT Product Issues None View
Atrial Fibrillation (AF) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Premature Ventricular Contractions (PVC) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral Vascular Disease SYSTEMATIC_ASSESSMENT General disorders None View
Mitral Regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tricuspid Regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain - Ischemic SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain - Other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other - Patient condition SYSTEMATIC_ASSESSMENT General disorders None View
Transient Ischemic Attack (TIA) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular Accident (CVA) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident (CVA) - ischemic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumothorax - unrelated procedure/device SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other - Unrelated to procedure/device SYSTEMATIC_ASSESSMENT General disorders None View
Adverse Reaction - Medication SYSTEMATIC_ASSESSMENT General disorders None View
Other - Patient condition SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
System Infection SYSTEMATIC_ASSESSMENT Product Issues None View
Fever and/or Virus SYSTEMATIC_ASSESSMENT General disorders None View
Physical Trauma SYSTEMATIC_ASSESSMENT General disorders None View
Localized Infection SYSTEMATIC_ASSESSMENT General disorders None View
Hematological SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other - Whole body SYSTEMATIC_ASSESSMENT General disorders None View
Genitourinary SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nonsustained ventricular tachycardia (NSVT) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Extracardiac Stimulation - LV PG System SYSTEMATIC_ASSESSMENT Product Issues None View
Inappropriate tachy therapy - SVT - Defibrillation Lead SYSTEMATIC_ASSESSMENT Product Issues None View
Extracardiac Stimulation - LV Lead SYSTEMATIC_ASSESSMENT Product Issues None View
Hematoma - pocket (<= 30 days post-implant) SYSTEMATIC_ASSESSMENT Product Issues None View
Chest Pain - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal Failure/Insufficiency - Heart Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dehydration - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure Symptoms - Unspecified SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multiple Heart Failure Symptoms SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other - Heart failure patient condition SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Fibrillation (VF) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Tachycardia (VT)/Monomorphic VT SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation (AF) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension/Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension/Hypertensive Crisis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral Regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other - Patient condition SYSTEMATIC_ASSESSMENT General disorders None View
Transient Ischemic Attack (TIA) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracardiac thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemorrhage - unrelated procedure/device SYSTEMATIC_ASSESSMENT General disorders None View
Pleural Effusion - unrelated procedure/device SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Adverse Reaction - Medication SYSTEMATIC_ASSESSMENT General disorders None View
System Infection SYSTEMATIC_ASSESSMENT Product Issues None View
Fever and/or Virus SYSTEMATIC_ASSESSMENT General disorders None View
Physical Trauma SYSTEMATIC_ASSESSMENT General disorders None View
Hematological SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Genitourinary SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Integumentary SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Head, eyes, ears, nose, throat (HEENT) SYSTEMATIC_ASSESSMENT General disorders None View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Inappropriate Tachy Therapy - Other - PG SYSTEMATIC_ASSESSMENT Product Issues None View