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 @ 12:18 PM
Ignite Modification Date: 2025-12-25 @ 12:02 PM
NCT ID: NCT01185561
Description: None
Frequency Threshold: 0
Time Frame: Adverse data were collected for 2 years, 8 months
Study: NCT01185561
Study Brief: A Pychoeducational Intervention for Women With Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Psychoeducational Intervention Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills. None None 1 38 2 38 View
Usual Medical Care Participants assigned to this arm represent the control group and will receive usual medical care only. None None 0 36 0 36 View
Serious Events(If Any):

Serious Events

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

Other Events

Term Type Organ System Vocab View
Worsening mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View