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 |
|---|---|---|---|---|---|---|---|---|
| Arm 1 - Pre and Post Modification Observation, No Intervention | In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket. | 0 | None | 0 | 17 | 0 | 17 | View |
| Arm 2 - Treatment Group, Pre and Post Modification | Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3. | 0 | None | 0 | 16 | 0 | 16 | View |
| Arm 2 - Control Group, Pre and Post Modification | Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist. | 0 | None | 0 | 16 | 0 | 16 | View |
| Arm 2 - Treatment Group Prosthetists, Pre and Post Modifications | Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well. | 0 | None | 0 | 8 | 0 | 8 | View |
| Arm 2 - Control Group Prosthetists, Pre and Post Modifications | Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well. | 0 | None | 0 | 9 | 0 | 9 | View |