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 @ 7:16 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT00095303
Description: Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT00095303
Study Brief: Brief Strategic Family Therapy for Adolescent Drug Abusers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BSFT Brief Strategic Family Therapy For Adolescent Drug Abusers: BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school). None None 16 245 144 245 View
Treatment as Usual Treatment as Usual: TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period. None None 16 235 133 235 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Physical/ Sexual Abuse SYSTEMATIC_ASSESSMENT Social circumstances None View
Suicidal Behavior SYSTEMATIC_ASSESSMENT Social circumstances None View
Homicidal Behavior SYSTEMATIC_ASSESSMENT Social circumstances None View
Hospitalization SYSTEMATIC_ASSESSMENT Social circumstances None View
Death SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Unexpected SAE SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrest SYSTEMATIC_ASSESSMENT Social circumstances None View
Runaway SYSTEMATIC_ASSESSMENT Social circumstances None View
Kicked out of home SYSTEMATIC_ASSESSMENT Social circumstances None View
Violence SYSTEMATIC_ASSESSMENT Social circumstances None View
School suspension SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Unexpected Adverse Event SYSTEMATIC_ASSESSMENT Social circumstances None View