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 @ 12:18 PM
Ignite Modification Date: 2025-12-25 @ 12:02 PM
NCT ID: NCT04451161
Description: Any adverse events (including serious ones) were only collected for students (none collected for providers). Identified through a CPSS-V item assessing self-harm (other adverse event). If a student scored \>0 ('not at all') on this item, the protocol followed: Notifying the school mental health provider (provider participant) and the parent (with the student's consent). Based on the severity, escalating to the on-call study clinician to develop a safety plan.
Frequency Threshold: 5
Time Frame: 6 months- Baseline (T1), 3-month follow up (T2), 6-month follow up (T3)
Study: NCT04451161
Study Brief: A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BASIS With TF-CBT (Student) Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT). 0 None 0 34 3 34 View
Attention Control With TF-CBT (Student) Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention. 0 None 0 32 4 32 View
Enhanced Treatment as Usual (Student) Students recruited by providers who received control for both implementation and clinical intervention. 0 None 0 35 2 35 View
BASIS With TF-CBT (Provider) Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT. 0 None 0 0 0 0 View
AC (Attention Control) With TF-CBT (Provider) Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention. 0 None 0 0 0 0 View
Enhanced Treatment as Usual (Provider) Participants who received control for both implementation and clinical intervention. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Suicidal Ideation/ Self-harm SYSTEMATIC_ASSESSMENT Social circumstances Other View