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 |
|---|---|---|---|---|---|---|---|---|
| an Offline Supportive Care Program | This was done routinely in accordance with the requirements of public health services for chronic diseases in the community elderly. In addition, health education on diabetes mellitus and dementia was provided to the caregivers during their monthly home visits. ① the content of diabetes health education: the researcher gave the caregivers education and training on the care of diabetes patients: the main points of care in diet, sleep, exercise, etc. ② The content of dementia health education: the researcher gave the caregivers education and training related to the care of dementia patients: instructing the caregivers in the basic life care skills of patients' diet, sleep, exercise, etc. Offline supportive care: This was done routinely in accordance with the requirements of public health services for chronic diseases in the community elderly. In addition, health education on diabetes mellitus and dementia was provided to the caregivers during their monthly home visits. ① the content of diabetes health education: the researcher gave the caregivers education and training on the care of diabetes patients: the main points of care in diet, sleep, exercise, etc. ② The content of dementia health education: the researcher gave the caregivers education and training related to the care of dementia patients: instructing the caregivers in the basic life care skills of patients' diet, sleep, exercise, etc. | 3 | None | 0 | 0 | 0 | 0 | View |
| mHealth Supportive Care Program | On the basis of the monthly home visits in the control group, "Xiamen iHealth" was used as a medium to add a weekly mHealth supportive care intervention program, with one supportive care item every two weeks for 12 weeks, for a total of 12 online interventions, as well as to provide online consultation and appointment services for caregivers at any time. mHealth Supportive Care Program: On the basis of monthly home visits in the control group, a weekly mHealth supportive care intervention program was added through the medium of Xiamen iHealth, with one supportive care item every two weeks for 12 weeks, for a total of 12 online interventions, as well as the provision of online consulting and booking services for caregivers at any time. | 2 | None | 0 | 0 | 0 | 0 | View |