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 @ 7:35 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT00053703
Description: None
Frequency Threshold: 5
Time Frame: 8 weeks, Systematic events
Study: NCT00053703
Study Brief: Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Olanzapine oral olanzapine 5-20mg per day for up to 52 weeks None None 2 35 26 35 View
Risperidone oral risperidone 0.5mg to 6mg daily for up to 52 weeks None None 4 41 35 41 View
Molindone oral molindone from 10-140mg/daily for up to 52 weeks None None 2 40 36 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Psychiatric Hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal Thoughts (life-threatening) NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increase in appetite SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Menstrual Irregularities SYSTEMATIC_ASSESSMENT General disorders None View
Sedation/Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
weight gain SYSTEMATIC_ASSESSMENT General disorders None View