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 @ 2:04 AM
Ignite Modification Date: 2025-12-26 @ 12:29 AM
NCT ID: NCT00959660
Description: None
Frequency Threshold: 0
Time Frame: 20 weeks
Study: NCT00959660
Study Brief: Exercise Intolerance in Elderly Patients With Diastolic Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dietary Intervention A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week. Dietary Intervention: Subjects will be provided meals and instructions for individual food selections. None None 0 24 1 24 View
Exercise Training Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject. Exercise: walking, treadmill and bicycle exercise None None 1 26 2 26 View
Attention Control Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status. Attention Control: control group- continue their previously randomized life style None None 1 25 0 25 View
Diet and Exercise The diet and exercise group is a combination of the two groups previously described. Exercise: walking, treadmill and bicycle exercise Diet and exercise: Combination of the exercise and diet group as previously described. None None 1 25 2 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heart failure exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Leg edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stress fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tendon tear SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View