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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT00288860
Description: Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT00288860
Study Brief: Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Telephone Monitoring Telephone monitoring as augmentation to treatment as usual Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications) None None 16 412 1 412 View
Treatment-As-Usual Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications) None None 12 425 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death doe to causes not known NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Hospitalization for overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization for cardiology or chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Scheduled laminotomy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Psychiatric Hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
hospitalized for cellulitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
kidney failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Arrest or incarceration NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Admitted to nursing home - reason not known NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Phone telephone care management upsetting NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View