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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT00725504
Description: The definitions for adverse event and serious adverse event did not differ from clinicaltrials.gov.
Frequency Threshold: 0
Time Frame: Adverse event data were collected during the infusion period (approximately one hour) for each participant.
Study: NCT00725504
Study Brief: Effect of IV Lidocaine Infusions on Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lidocaine Infusion Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml. None None 0 71 9 71 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Transient central nervous system side effects NON_SYSTEMATIC_ASSESSMENT General disorders None View