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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT03810456
Description: Adverse events were systematically evaluated throughout the course of the study, from baseline through the last follow-up period. At each time point, medical records for each participant were reviewed and symptoms were monitored through measures administered to each participant. One participant randomized to the sCBT arm was excluded from analyses due to not meeting study inclusion criteria.
Frequency Threshold: 0
Time Frame: 3 years, 7 months
Study: NCT03810456
Study Brief: Transdiagnostic Cognitive Behavioral Treatment for Anxiety
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
iCBT (Intensive Cognitive Behavioral Therapy) Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend. Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises. 0 None 0 99 0 99 View
sCBT (Standard Cognitive Behavioral Therapy) Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks. Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises. 0 None 0 98 0 98 View
TAU (Treatment as Usual) Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual. 0 None 0 67 0 67 View
Serious Events(If Any):
Other Events(If Any):