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: 2025-12-26 @ 2:39 PM
Ignite Modification Date: 2025-12-26 @ 2:39 PM
NCT ID: NCT03560206
Description: We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.
Frequency Threshold: 0
Time Frame: 1 year follow up from the baseline data collection
Study: NCT03560206
Study Brief: Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Family SWaP Intervention an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad. Family SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet. 4 None 23 158 0 158 View
Usual Care The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so. usual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so. 2 None 28 158 0 158 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac death SYSTEMATIC_ASSESSMENT Cardiac disorders Serious View
Non-cardiac Death SYSTEMATIC_ASSESSMENT Investigations Serious View
Cardiac Hospitalization SYSTEMATIC_ASSESSMENT Cardiac disorders Serious View
Non-cardiac Hospitalization SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Serious View
Other Events(If Any):