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 @ 3:40 PM
Ignite Modification Date: 2025-12-25 @ 1:50 PM
NCT ID: NCT03954392
Description: The definition used to collect adverse event information was from the clinicaltrials.gov Definitions.
Frequency Threshold: 0
Time Frame: The period of time over which adverse event data were collected was baseline to 2.5 years. For each participant, the time frame was baseline through their study completion (about 14 weeks).
Study: NCT03954392
Study Brief: CBT Enhanced With Social Cognitive Training
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CBT+SCT Cognitive behavioral therapy plus social cognitive skills training (SCT) Cognitive behavior therapy with social cognitive training (CBT+SCT): The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, the investigators will teach the teen explicitly about theory of mind and social perspective taking during each session and we will use examples from their own life to help them learn the skills. 0 None 0 23 0 23 View
CBT-only Cognitive behavioral therapy only (without SCT) CBT-only: The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. The investigators will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. 0 None 0 22 0 22 View
Serious Events(If Any):
Other Events(If Any):