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 |
|---|---|---|---|---|---|---|---|---|
| Ostomy Self Management Training | The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones. Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations | 8 | None | 0 | 106 | 0 | 106 | View |
| Usual Care | Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys. | 11 | None | 0 | 110 | 0 | 110 | View |