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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT01847469
Description: Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT01847469
Study Brief: Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid 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 Participants in this arm will receive zonisamide for 12 weeks. Enhanced-Cognitive Processing Therapy-C (E-CPT-C) Zonisamide 0 None 1 18 6 18 View
Placebo Participants in this arm will receive placebo medication for 12 weeks. Enhanced-Cognitive Processing Therapy-C (E-CPT-C) Placebo 0 None 2 6 2 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
Breast Swelling NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Difficulty Sleeping SYSTEMATIC_ASSESSMENT General disorders None View
Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Libido SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View