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 @ 2:14 AM
Ignite Modification Date: 2025-12-26 @ 12:43 AM
NCT ID: NCT03092960
Description: None
Frequency Threshold: 0
Time Frame: 18 months
Study: NCT03092960
Study Brief: The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Minimal Intensity Intervention Patients assigned to this group will received the Minimal intensity intervention. Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant. 0 None 15 212 48 212 View
HOMBRE Patients assigned to this group will receive the HOMBRE intervention HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach. 0 None 14 212 52 212 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Endocrine disorders SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Gastrointestinal Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Immune System Disorders SYSTEMATIC_ASSESSMENT Immune system disorders None View
Musculoskeletal and Connective Tissue Disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Renal and Urinary Disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory, Thoracic and Mediastinal Disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin and Subcutaneous Tissue Disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infections and Infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal and Connective Tissue Disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Skin and Subcutaneous Tissue Disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Endocrine Disorders SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Gastrointestinal Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders SYSTEMATIC_ASSESSMENT General disorders None View
Nervous System Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal and Urinary Disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory, Thoracic and Mediastinal Disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View