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: 2025-12-25 @ 4:52 AM
Ignite Modification Date: 2025-12-26 @ 3:52 AM
NCT ID: NCT00531518
Description: None
Frequency Threshold: 5
Time Frame: Over 24 months
Study: NCT00531518
Study Brief: Early Detection and Intervention for the Prevention of Psychosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff. None None 1 87 19 87 View
Family-aided Assertive Community Treatment This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education . aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals. None None 0 205 51 205 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Negative events SYSTEMATIC_ASSESSMENT Psychiatric disorders None View