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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT02498769
Description: None
Frequency Threshold: 5
Time Frame: Adverse events from the time of randomization through hospital discharge following study surgery.
Study: NCT02498769
Study Brief: Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Epicardial Botulinum After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated. 1 None 27 63 10 63 View
Epicardial Placebo After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Placebo 1 None 30 67 14 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Dysrhythmia - Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Heart Block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reexploration For Bleeding NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Left pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal dysphagia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sternal Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute abdomen dilation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute respiratory failure/hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Altered Mental Status NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bilateral Toe and Index finger ischemia. NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dialysis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypovolemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
IABP placement NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea/Vomiting/Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pacemaker Placement NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Reintubation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal Insufficiency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right sided weakness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary Incontinence leading to foley re-insertion NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ventricular Dysrhythmia - Ventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
junctional rhythm NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
post-op hemorrhage, back to OR for re-exploration NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Post-op blood loss anemia requiring transfusions NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
prolonged hospitalization c/o coagulation. NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial Dysrhythmia - Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View