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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Standard Care/Tele-cardiology | * Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists. * Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period. | 90 | None | 0 | 0 | 0 | 0 | View |
| Tele-cardiology Group/Tele-cardiology | \- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. \- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period. | 99 | None | 0 | 0 | 0 | 0 | View |