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 @ 12:09 AM
Ignite Modification Date: 2025-12-25 @ 10:08 PM
NCT ID: NCT03305458
Description: Adverse events were monitored and assessed by our clinical supervisors.
Frequency Threshold: 1
Time Frame: 52 weeks, 1 year
Study: NCT03305458
Study Brief: Improving Quality of Care in Child Mental Health Service Settings
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tablet-Facilitated TF-CBT Standard treatment with the addition of in-treatment/session iPad activities eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT) 4 None 4 320 21 320 View
Not Randomized Providers who are enrolled into the study but did not have a family enrolled. 0 None 0 126 0 126 View
Treatment as Usual Trauma Focused Cognitive Behavioral Therapy TFCBT: treatment as usual 0 None 2 267 15 267 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide Ideations SYSTEMATIC_ASSESSMENT Investigations None View
Self Harm SYSTEMATIC_ASSESSMENT Investigations None View
Caregiver Death SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Suicide Ideation/ Self Harm SYSTEMATIC_ASSESSMENT Investigations None View
Patient taken to a Inpatient Clinic SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Informing Therapist SYSTEMATIC_ASSESSMENT Investigations None View
DSS Reports SYSTEMATIC_ASSESSMENT Investigations None View