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 @ 4:23 AM
Ignite Modification Date: 2025-12-26 @ 3:26 AM
NCT ID: NCT01983020
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01983020
Study Brief: Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine 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
Ketamine Ketamine infused at 0.25 mg/kg/hour. Ketamine None None 1 12 2 12 View
Lidocaine Lidocaine infused at 0.5 mg/kg/hour. Lidocaine None None 0 11 2 11 View
Ketamine and Lidocaine Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour Lidocaine Ketamine None None 3 12 6 12 View
Placebo Placebo (saline) given to compare usual treatment against active agents in post operative pain management. None None 1 11 6 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Respiratory Depression SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Low Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cold Sweats SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Itching SYSTEMATIC_ASSESSMENT General disorders None View
Sedation SYSTEMATIC_ASSESSMENT General disorders None View