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 @ 4:34 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT05087966
Description: An adverse event is defined as any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign, symptom, or disease, temporally associated with participant's study participation, whether or not considered related to participant's study participation; it encompasses both physical and psychological harm. This study also included non-medical events that may be behavioral (i.e., self-harm) or social (e.g., child protective services involvement with the family).
Frequency Threshold: 0
Time Frame: Six months
Study: NCT05087966
Study Brief: Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety Planning Intervention With Navigation Services A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community). Safety Planning Intervention with Navigation Services: A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community). 0 None 2 31 4 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization Following Method Research SYSTEMATIC_ASSESSMENT Psychiatric disorders US DHHS OHRP View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders US DHHS OHRP View
Hospitalization Following Symptom Worsening SYSTEMATIC_ASSESSMENT Psychiatric disorders US DHHS OHRP View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders US DHHS OHRP View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Concerns Following Interview Questions SYSTEMATIC_ASSESSMENT Investigations US DHHS OHRP View
Interrupted Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders US DHHS OHRP View
Hospitalization for Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders US DHHS OHRP View
Emergency Room Visit SYSTEMATIC_ASSESSMENT Psychiatric disorders US DHHS OHRP View