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 |
|---|---|---|---|---|---|---|---|---|
| Blue Prescription Group | Participants will get an exercise program, which is designed by their needs, desires and abilities. They will perform a desired exercise program 3 days a week and they will make an interview for motivation and/or modifying the program one day a week. They will write an activity diary. Blue Prescription Exercise Program: After the evaluation, DM and physical activity training will be given, the benefits of exercise will be explained and these will be given as a brochure. It will be followed up with the blue prescription program once a week for 12 weeks and will be re-evaluated at the end of the 12th week. Motivation and support will be provided according to the blue prescription philosophy, home exercise program, physical activity selection, obstacles to the activity are discussed, the participant will be asked to determine the appropriate program and keep an activity diary. Throughout the study, the participant will be able to communicate with the physiotherapist by any method (phone, SMS, email). | 0 | None | 0 | 20 | 0 | 20 | View |
| Video Based Home Exercise Group | Participants will get videos by different ways (closed link youtube, whatsapp, flash driver etc.). They will perform exercises 3 days a week. İnvestigator will phone them to ask whether they do the program or not. They will write an activity diary. Video Based Home Exercise Program: After the evaluation, DM and physical activity training will be given, the benefits of exercise will be explained and these will be given as a brochure. A video exercise program will be given in the format and method desired by the participant. It will be evaluated again at the end of the 12th week. | 0 | None | 0 | 20 | 0 | 20 | View |
| Supervised Exercise Group | Participants will perform an exercise program 3 days a week with a physiotherapist. The group will be held maximum 10 people. Supervised Group Exercise Program: DM and physical activity training will be given after the assessment, the benefits of the exercise will be explained and these will be given as a brochure. Exercises will be done with a physiotherapist for 12 weeks 3 days a week and will be evaluated again at the end of the 12th week. | 0 | None | 0 | 20 | 0 | 20 | View |