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 |
|---|---|---|---|---|---|---|---|---|
| Glenoid Positioning System | For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments. Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component | 0 | None | 0 | 15 | 0 | 15 | View |
| Standard Group | Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan. | 0 | None | 0 | 16 | 0 | 16 | View |