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 @ 2:22 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT03657459
Description: Adverse events were NON-treatment-related as the intervention was video education. The IRB approved this study as minimal risk and adverse events were NOT collected or recorded except those believed to be important indirect (no direct) heart failure and all-cause 180 day outcomes (death, emaergency department visits and hospitalizations). Patient charts were monitored for the above outcomes at180 days (6 months).
Frequency Threshold: 5
Time Frame: Adverse events recorded for this study were NON-treatment-related. Patient charts were monitored at 180 days (6 months) and considered to be non-direct patient outcomes becasue of the nature of participants medical condition, in general.
Study: NCT03657459
Study Brief: Danger Signs in Heart Failure- Effects of Video Education
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 Group Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs 42 None 232 377 0 377 View
Video Education Group Will receive usual care, plus will watch short videos from Wellflix, Inc.: 1) "Danger Signs of Heart Failure" videos (via iPAD) on dyspnea and fatigue; and 2) "Danger Signs edema" video. Each video describes how to recognize if the patient's signs/symptoms are new or worsening and how to self-manage at home via diet, fluid management, and physical activity instructions. Danger Signs of Heart Failure Videos are short videos (less than 3 minutes each). The videos contain educational information on (a) recognition of dyspnea, fatigue, and edema; and (b) self-management (based on diet, fluid management, and activities) 40 None 242 369 0 369 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
All-cause 180 day emergency department, hospitalization, transplant/left ventricular assist device o SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):