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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:11 AM
NCT ID: NCT03196505
Description: None
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT03196505
Study Brief: The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric 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
Liposomal Bupivacaine Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). 0 None 5 89 0 89 View
Control 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). 0 None 3 90 0 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Reoperations NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED CT View
Readmission to hospital NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Other Events(If Any):