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 @ 3:54 AM
Ignite Modification Date: 2025-12-26 @ 2:44 AM
NCT ID: NCT01208402
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01208402
Study Brief: Esmolol for Treatment of Perioperative Tachycardia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Long-Acting Beta Blocker Administer patient's routine oral long acting beta blocker on day of surgery (standard of care). None None 2 31 16 31 View
Esmolol Replace patient's routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively. None None 2 28 19 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intra-abdominal retroperitoneal abscess None Gastrointestinal disorders None View
Change in Mental Status None Psychiatric disorders None View
Hemorrhage None Blood and lymphatic system disorders None View
myocardial infarction None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HYERTENSION None Cardiac disorders None View
VOMITING None Gastrointestinal disorders None View
CONSTIPATION None Gastrointestinal disorders None View
HEARTBURN None Gastrointestinal disorders None View
HYPOMAGNESEAMIA None Blood and lymphatic system disorders None View
Low urine output None Renal and urinary disorders None View
Urinary tract infection None Renal and urinary disorders None View
NAUSEA None Gastrointestinal disorders None View
DIARRHIA None Gastrointestinal disorders None View
ABDOMINAL PAIN None Gastrointestinal disorders None View
CONFUSION None Nervous system disorders None View
HYPERGLYCEMIA None Metabolism and nutrition disorders None View
DIFFICULTY OF BREATHING None Respiratory, thoracic and mediastinal disorders None View
ATELECTASIS None Respiratory, thoracic and mediastinal disorders None View
DIAPHORESIS None Cardiac disorders None View
ILEUS None Gastrointestinal disorders None View
WOUND INFECTION None Infections and infestations None View
CHEST PAIN None Cardiac disorders None View
TACHYCARDIA None Cardiac disorders None View
HYPOXIA None Respiratory, thoracic and mediastinal disorders None View
Productive cough None Respiratory, thoracic and mediastinal disorders None View
Decrease urine output None Renal and urinary disorders None View
Intra-abdominal retroperitoneal abscess None Infections and infestations None View
Mildly elevated serum creatinine None Renal and urinary disorders None View
ATRIAL FIBRILLATION None Cardiac disorders None View
Fever None General disorders None View
PULMONARY EDEMA None Respiratory, thoracic and mediastinal disorders None View
HYPERNATREMIA None Blood and lymphatic system disorders None View
CHANGED MENTAL STATUS None Nervous system disorders None View
HYPOTENSION None Cardiac disorders None View
PNEUMONIA None Respiratory, thoracic and mediastinal disorders None View
HYPONATREMIA None Blood and lymphatic system disorders None View
HYPOKALEMIA None Blood and lymphatic system disorders None View
DIFUSE BRAIN DISFUNCTION None Nervous system disorders None View
POST-SURGICAL BLEEDING None Surgical and medical procedures None View
POST-SURGICAL HEMATOMA None Surgical and medical procedures None View
ANEMIA None Blood and lymphatic system disorders None View
None reversible ischemia in the inferior right heart None Cardiac disorders None View
Agitation None Nervous system disorders None View
DELIRIUM TREMENS None Nervous system disorders None View
Mild right hydronephrosis None Renal and urinary disorders None View
INTRA-OPERATIVE BLEEDING None Surgical and medical procedures None View
BRADYCARDIA None Cardiac disorders None View
Elevated troponin None Cardiac disorders None View
Heavy feeling bilateral arm None Musculoskeletal and connective tissue disorders None View
Clumsiness left arm None Musculoskeletal and connective tissue disorders None View
Apresthesia None General disorders None View
Significant SQ air with SOB None Respiratory, thoracic and mediastinal disorders None View
POST DISCHAGE PAIN None Surgical and medical procedures None View