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 @ 12:00 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT03292458
Description: Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
Frequency Threshold: 0
Time Frame: 5 hours and a 24-hour follow-up
Study: NCT03292458
Study Brief: Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group. 0 None 0 56 13 56 View
Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. 0 None 0 50 29 50 View
Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. 0 None 0 50 8 50 View
Sodium Oxybate: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group. 0 None 0 56 37 56 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild Disorientation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Depression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Feeling hangover SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Moderate Dizziness/ lightheadedness/unsteadiness/clumsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Dizziness/ lightheadedness/unsteadiness/clumsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Blurred vision SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Trouble concentrating SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Nervousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild Daytime sleepiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Moderate Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild Restlessness SYSTEMATIC_ASSESSMENT Nervous system disorders None View