Adverse Events Module

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 @ 4:55 PM
Ignite Modification Date: 2025-12-25 @ 2:38 PM
NCT ID: NCT03401450
Description: None
Frequency Threshold: 0
Time Frame: 24 hours
Study: NCT03401450
Study Brief: Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ACB Within True AC With Bupivacaine The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block. 0 None 0 20 0 20 View
ACB Proximal to True AC With Bupivacaine The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine 0 None 0 23 0 23 View
Serious Events(If Any):
Other Events(If Any):