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 |
|---|---|---|---|---|---|---|---|---|
| Control | Motivational notifications were not sent to the nurses in the control group (n=30) and they continued their routine work in the emergency room. only pretest and posttest were applied. Data were obtained with the Individual Introduction Form, Job Satisfaction, Compassion Fatigue and Communication Skills Scale. | 0 | None | 0 | 30 | 0 | 30 | View |
| Motivation | Motivational notifications were sent to the nurses in the motivational group (n=30) via SMS messages to their mobile phones at 07.00, 12.00 and 16.00 for 21 days. Like a good morning message that allows you to start the day with a beautiful energy (Example: Thank you for the hard and selfless work you do every day. We love and appreciate angels like you and you. Good morning). Motivational notifications sent to the participants were prepared each day to be different from the previous day. Data were obtained with the Individual Introduction Form, Job Satisfaction, Compassion Fatigue and Communication Skills Scale. Motivation: Motivational notifications were sent via SMS message to the nurses in the motivation group (n=30) at 07.00, 12.00 and 16.00 for 21 days. | 0 | None | 0 | 30 | 0 | 30 | View |