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 @ 5:23 PM
Ignite Modification Date: 2025-12-25 @ 2:58 PM
NCT ID: NCT00566150
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected during course of the study and for two weeks after last study intervention.
Study: NCT00566150
Study Brief: Levetiracetam in the Management of Bipolar Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Levetiracetam Subjects on active study medication. None None 0 19 17 19 View
Placebo Subjects assigned to placebo control group. None None 0 16 15 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
GI symptoms NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Coordination NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shakiness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weakness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypomanic symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Worsening of depressive symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Slurred speech NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sunstance Abuse Relapse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increase in suicidality NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Drooling NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Genitourinary NON_SYSTEMATIC_ASSESSMENT General disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unusual dreams/nightmares NON_SYSTEMATIC_ASSESSMENT General disorders None View
Taste NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nosebleed NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle soreness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cold NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cognitive NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View