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 |
|---|---|---|---|---|---|---|---|---|
| Adapted LiFE | Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit. Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar. | 0 | None | 0 | 8 | 0 | 8 | View |
| Attention Control | Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit. Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest. | 0 | None | 0 | 9 | 0 | 9 | View |