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 @ 7:11 PM
Ignite Modification Date: 2025-12-25 @ 4:46 PM
NCT ID: NCT02363803
Description: None
Frequency Threshold: 0
Time Frame: 0-120 minutes after infusion initiation
Study: NCT02363803
Study Brief: Lidocaine for Diabetic Peripheral Neuropathy
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 Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period. lidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias. 0 None 0 34 13 34 View
Normal Saline Infusion Intravenous infusion of normal saline over a 40 minute period. Placebo: Normal saline, approved for hypovolemia, and homeostasis. 0 None 0 33 11 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Slurred speech NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Drowsiness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Perioral numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View