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 @ 11:20 PM
Ignite Modification Date: 2025-12-25 @ 9:03 PM
NCT ID: NCT00595556
Description: None
Frequency Threshold: 0
Time Frame: 14 weeks
Study: NCT00595556
Study Brief: Zonisamide vs. Placebo in the Treatment of Alcohol Dependence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zonisamide Medication Treatment Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo. None None 0 20 16 20 View
Placebo Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm. None None 0 20 16 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurologic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cognitive SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Genitourinary SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Fatigue/Somnolence SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View