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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:32 PM
NCT ID: NCT04896593
Description: None
Frequency Threshold: 1
Time Frame: From study enrollment through 16 weeks post-discharge assessment.
Study: NCT04896593
Study Brief: Mobile Technology for Reducing and Preventing Adolescent Suicide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills. 0 None 9 22 19 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Inpatient hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headaches SYSTEMATIC_ASSESSMENT General disorders None View
Increase in anger SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increase in SIQ-Jr total score above threshold SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased fatigue in swimming SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sinus issue SYSTEMATIC_ASSESSMENT General disorders None View
Feeling more down SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Weight gain SYSTEMATIC_ASSESSMENT General disorders None View
Medication side effects SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased mania SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sexual assault SYSTEMATIC_ASSESSMENT Social circumstances None View
Thoughts of self-harm SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ER and Urgent Care visits for migraines and vomiting. SYSTEMATIC_ASSESSMENT General disorders None View
ER visit for dizziness and not eating or drinking SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19+ SYSTEMATIC_ASSESSMENT General disorders None View
ER visit for vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Increased stress, DCF involvement SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ER visit due to allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Viral respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Passive suicidal ideation, feeling more down SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ER visit for suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View