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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:05 AM
NCT ID: NCT00731094
Description: The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
Frequency Threshold: 5
Time Frame: Data for adverse events were collected during the 12-month follow-up period.
Study: NCT00731094
Study Brief: The VA-STRIDE Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Physical Activity Intervention Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model None None 29 116 0 116 View
Attention Control Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity None None 33 116 0 116 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac catheterization SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pains/pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acid reflux/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gallbladder problems SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Eye trauma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sleep apnea SYSTEMATIC_ASSESSMENT Investigations None View
Vertigo SYSTEMATIC_ASSESSMENT Investigations None View
Nerve pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety/stress SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Kidney stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fluid retention in leg SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cataract surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Colectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hernia surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee/ankle surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Lymphadenectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pacemaker inserted SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Prostate surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Shoulder surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):