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 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT03599635
Description: None
Frequency Threshold: 0
Time Frame: One year
Study: NCT03599635
Study Brief: Pec Infiltration With Liposomal Bupivacaine for Breast 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
EVEN Number = PEC Block Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline. 0 None 0 56 7 56 View
ODD Number = Surgeon Infiltration 30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline. 0 None 0 55 6 55 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea/ Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View