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 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:52 PM
NCT ID: NCT01905267
Description: Study staff informed of hospitalizations for suicidality or increasing depressive symptoms during course of KSADS clinical assessments
Frequency Threshold: 5
Time Frame: two years following 8 week intervention period every six months
Study: NCT01905267
Study Brief: Mindfulness Intervention to Study the Neurobiology of Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy Rumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length. 0 None 0 17 0 17 View
Control Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study 0 None 5 16 0 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidality NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):