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 @ 6:37 PM
Ignite Modification Date: 2025-12-25 @ 4:07 PM
NCT ID: NCT02052557
Description: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.
Frequency Threshold: 0
Time Frame: The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.
Study: NCT02052557
Study Brief: The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon 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
Bupivacaine 30 milliliters (ml) of 0.5% marcaine with epinephrine Bupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR 0 None 0 0 0 0 View
Bupivacaine Liposome Suspension exparel 20ml, diluted with 10ml sterile saline for total of 30ml Bupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):