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 @ 2:31 PM
Ignite Modification Date: 2025-12-25 @ 1:04 PM
NCT ID: NCT02604459
Description: Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02604459
Study Brief: Does Optimized General Anesthesia Care Reduce Postoperative Delirium?
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Comparator: Usual General Anesthesia Care Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane 8 None 26 56 25 56 View
Experimental: Optimized General Anesthesia Care The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables. 6 None 28 53 20 53 View
Mini Mental State Exam Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane 10 None 11 22 0 22 View
Tested and Excluded Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
T12-L1 spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ulcers SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Eye surgery SYSTEMATIC_ASSESSMENT Eye disorders None View
Cardiac arrest requiring cardiopulmonary resuscitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bone fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pituitary tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Avascular necrosis of femoral head SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypotension SYSTEMATIC_ASSESSMENT General disorders None View
Inguinal hernia SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Total knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Non-ST-elevation myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pelvic ring fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cholecystitis/cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Leg pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Carotid endarterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Respiratory distress SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Leg surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee replacement surgery SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Altered mental status SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Tibia/fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Organ/space surgical site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dysarthria SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Failed open reduction internal fixation of patella SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Liver failure SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pneumothorax with chest tube SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stroke/cerebral vascular attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transfusion of packed red blood cells SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intensive care unit admission SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia/urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Deep incisional surgical site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute hypoxic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hip dislocation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Surgical hardware removal SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Severe aortic stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Superficial incisional surgical site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Maxillary sinus tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Abdominal swelling SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysphagia/dysphonia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Unplanned intubation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Aspiration pneumonitis/pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Superficial incisional surgical site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Transfusion of packed red blood cells SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Organ/space surgical site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View