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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT00853593
Description: Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
Frequency Threshold: 5
Time Frame: Subject enrollment-exit
Study: NCT00853593
Study Brief: Model 4396 Left Ventricular (LV) Lead 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
Model 4396 LV Lead Subjects successfully implanted with a Model 4396 LV lead. None None 76 197 27 197 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Alcoholic withdrawal symptoms None Psychiatric disorders None View
Allergic reaction None Skin and subcutaneous tissue disorders None View
Anemia None Blood and lymphatic system disorders None View
Aneurysm of aortic arch None Cardiac disorders None View
Asystole None Cardiac disorders None View
Atrial fibrillation None Cardiac disorders None View
Atrial fibrillation with rapid ventricular response None Cardiac disorders None View
Atrial flutter None Cardiac disorders None View
Atrial tachycardia None Cardiac disorders None View
Bladder cancer None Renal and urinary disorders None View
Breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cardiac arrest None Cardiac disorders None View
Cellulitis None Skin and subcutaneous tissue disorders None View
Central line infection None Infections and infestations None View
Cerebrovascular accident None Nervous system disorders None View
Chest pain None General disorders None View
Chest tenderness None General disorders None View
Cholelithiasis None Hepatobiliary disorders None View
Congestive heart failure None Cardiac disorders None View
COPD exacerbation None Respiratory, thoracic and mediastinal disorders None View
Coronary artery disease None Cardiac disorders None View
Coronary artery disease aggravated None Cardiac disorders None View
Decompensated heart failure None Cardiac disorders None View
Deep venous thrombosis arm None Vascular disorders None View
Degenerative joint disease None Musculoskeletal and connective tissue disorders None View
Device lead issue None Injury, poisoning and procedural complications None View
Diarrhea None Gastrointestinal disorders None View
Diverticulitis None Infections and infestations None View
Effusion pleural None Respiratory, thoracic and mediastinal disorders None View
Elevated pacing threshold None Injury, poisoning and procedural complications None View
Embolism pulmonary None Respiratory, thoracic and mediastinal disorders None View
Embolus None Vascular disorders None View
Femoral artery stenosis None Vascular disorders None View
Fever None General disorders None View
Fever of unknown origin None General disorders None View
Foot infection None Infections and infestations None View
Gastrointestinal bleeding None Gastrointestinal disorders None View
GI bleed None Gastrointestinal disorders None View
Gouty arthritis None Musculoskeletal and connective tissue disorders None View
Hematoma None General disorders None View
Herniated disc None Nervous system disorders None View
Hyperkalaemia None Blood and lymphatic system disorders None View
Hypotension None Vascular disorders None View
Hypothyroidism None Endocrine disorders None View
Implant site hematoma None General disorders None View
Implant site infection None Infections and infestations None View
Inadequate lead connection None Injury, poisoning and procedural complications None View
Inappropriate phrenic nerve stimulation None Injury, poisoning and procedural complications None View
Insulin hypoglycemia None Metabolism and nutrition disorders None View
Intracerebral hemorrhage None Nervous system disorders None View
Laceration of head None Injury, poisoning and procedural complications None View
Lead dislodgement None Injury, poisoning and procedural complications None View
Loss of capture None Injury, poisoning and procedural complications None View
Loss of control of diabetes None Metabolism and nutrition disorders None View
Middle cerebral artery stroke None Nervous system disorders None View
Multiple organ failure None General disorders None View
Myocardial infarction None Cardiac disorders None View
Near syncope None Nervous system disorders None View
Non ST segment elevation myocardial infarction None Cardiac disorders None View
Non-cardiac chest pain None General disorders None View
Palpitations None Cardiac disorders None View
Peripheral vascular disease None Vascular disorders None View
Pneumonia None Infections and infestations None View
Pneumothorax None Respiratory, thoracic and mediastinal disorders None View
Prostatic hypertrophy None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Sepsis None Infections and infestations None View
Small bowel obstruction None Gastrointestinal disorders None View
Spinal column stenosis None Nervous system disorders None View
Sudden cardiac death None Cardiac disorders None View
Syncope None Nervous system disorders None View
Transient ischemic attack (TIA) None Nervous system disorders None View
Triple vessel disease None Cardiac disorders None View
Twiddler's syndrome None Injury, poisoning and procedural complications None View
Uncontrolled hypertension None Vascular disorders None View
Urinary tract infection None Infections and infestations None View
Ventricular tachycardia None Cardiac disorders None View
Vertigo None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Inappropriate phrenic nerve stimulation None Injury, poisoning and procedural complications None View
Inappropriate stimulation of diaphragm None Injury, poisoning and procedural complications None View