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 @ 4:09 AM
Ignite Modification Date: 2025-12-26 @ 3:06 AM
NCT ID: NCT00738920
Description: None
Frequency Threshold: 1
Time Frame: 1 year
Study: NCT00738920
Study Brief: Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MC-CBT Self Administered Cognitive Behavior Therapy Self Administered Cognitive Behavior Therapy: This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS 0 None 0 145 0 145 View
Standard-CBT Therapist Administered Cognitive Behavior Therapy Therapist Administered Cognitive Behavior Therapy: This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS 0 None 0 146 0 146 View
Education/Support Behavioral Patient Education/Counseling Behavioral Education and Supportive Therapy: This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor 0 None 1 145 0 145 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Attempted suicide NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Events(If Any):