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 |
|---|---|---|---|---|---|---|---|---|
| Comparator Baseline | The subject wears their usual partial hand prosthesis while performing functional outcome measures. Subjects will test out this hand configuration in the lab while performing functional outcome measures. This testing occurs at a single site visit (1 day) and lasts approximately 4 hours. | 0 | None | 0 | 4 | 0 | 4 | View |
| Pointdexter | The subject wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. Subjects will test out this hand configuration in the lab while performing functional outcome measures. This testing occurs at a single site visit (1 day) and lasts approximately 4 hours. Pointdexter: i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger. | 0 | None | 0 | 4 | 0 | 4 | View |