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: 2025-12-24 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT04629066
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collected between consent and study completion, for a total of 13 weeks.
Study: NCT04629066
Study Brief: Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team. 0 None 1 7 0 7 View
Remote Prescription for Aerobic Exercise The exercise prescription will be created by an exercise physiologist after incorporating remotely collected data from a patient directed smartphone app assessing HF symptom severity, vital signs, weight, and blood sugar, and cardiac implant measures of physical activity, heart rate, heart failure volume status and heart rhythm, and Fitbit measures of physical activity. Remote Cardiac Rehabilitation (CR): Patients randomized to remote CR will be asked to use an app for cardiac rehabilitation a minimum of 3 times a week. Patients will be given an exercise prescription provided by a certified exercise physiologist. The exercise prescription will change each week based on refreshed data from the prior week. Instructional videos for each exercise are provided in the app. Patients will not be told to perform the exercise at a particular time. Instead they will be asked to complete a certain amount of exercise per week at whatever time is convenient for them. Patients randomized to remote CR will also receive App based reminders to take their medications, resources to guide healthy eating habits, and other behavioral health advice as is done as standard of care in both remote based and clinic based CR. 0 None 0 6 1 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stent Placement SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View