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 @ 3:11 AM
Ignite Modification Date: 2025-12-26 @ 1:49 AM
NCT ID: NCT02059005
Description: Serious Adverse Events were defined as death; a life threatening event such as suicidal ideation/attempt or inpatient rehospitalization related to the index medical condition, suicidal behavior, psychiatric distress, or drug/alcohol complications/overdose. Unrelated medical events that did not require hospitalization were not be considered SAEs.
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT02059005
Study Brief: Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Specialized Community Disease Management Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge. 1 None 23 49 0 49 View
Treatment As Usual Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use. 3 None 14 48 0 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization for cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization for Syncope SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization for drug/alcohol use SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Inpatient Drug/Alcohol SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Death, Cause Unknown NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization for congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization for COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization for Diabetes SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization for end-stage renal disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization for pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Suicidal ideation/attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Death related to congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):