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 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:06 AM
NCT ID: NCT00578318
Description: Since the participants in the study were at-risk for depression or met criteria for depression and the purpose of the study was to assist the participants in securing treatment for their depression, we did not assess any of the patients as at risk for adverse events since they were being followed clinically by the study PI and the PI's mentors.
Frequency Threshold: 5
Time Frame: Adverse event reporting occurred for the duration of data collection with this phase of the study from 2007 - 2011, including a 3 month follow up period after the last patient completed the protocol.
Study: NCT00578318
Study Brief: African American Knowledge Optimized for Mindfully Healthy Adolescents
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Motivational Interviewing Active 2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention None None 0 0 0 0 View
Delayed Control At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention. None None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):