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 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:34 PM
NCT ID: NCT01826851
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Study: NCT01826851
Study Brief: Parasternal Nerve Block in Cardiac Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exparel 266 mg Exparel, single-dose injection. Exparel: Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure. Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU. 0 None 4 38 38 38 View
Placebo 0.9% Normal saline, single-dose injection. Placebo: Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure. Post-surgical pain management will be the same as for the Exparel group. 0 None 10 41 40 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suspected bupivacaine toxicity SYSTEMATIC_ASSESSMENT General disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral vascular accident with permanent deficits SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mediastinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sternal wound dehiscence SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Reoperation due to graft failure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Reoperation for bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Renal failure requiring hemodialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Phrenic nerve Injury SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Readmission to ICU SYSTEMATIC_ASSESSMENT General disorders None View
Deep venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
New onset SVT or ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute limb ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Multiorgan failure SYSTEMATIC_ASSESSMENT General disorders None View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
New onset ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bundle Branch Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
First Degree AV Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Premature Atrial Contraction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Premature Ventricular Contraction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ST Changes SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT General disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness/Light headedness SYSTEMATIC_ASSESSMENT General disorders None View
Metallic Taste in Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Restlessness SYSTEMATIC_ASSESSMENT General disorders None View
Miosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Parasthesias SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tinnitis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremors SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Prolonged QT Interval SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diaphoresis SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Itching SYSTEMATIC_ASSESSMENT General disorders None View
Generalized Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View