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 @ 2:06 PM
Ignite Modification Date: 2025-12-25 @ 12:48 PM
NCT ID: NCT00394095
Description: Adverse events collected with open-ended questions and classified into categories by study team.
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT00394095
Study Brief: Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Comparator Group: Placebo Group Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks 0 None 1 14 13 14 View
Experimental Group: Topiramate Group Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks 0 None 2 16 15 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Malignant hyperthermia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper extremity paresthesia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Back and/or neck pain SYSTEMATIC_ASSESSMENT General disorders None View
Worsening of mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sedation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Earache SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Headaches SYSTEMATIC_ASSESSMENT General disorders None View
Ocular/visual blurriness SYSTEMATIC_ASSESSMENT Eye disorders None View