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 |
|---|---|---|---|---|---|---|---|---|
| Gabapentin Group | The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin prior to admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. | 0 | None | 0 | 21 | 0 | 21 | View |
| No Gabapentin Group | The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin during inpatient rehabilitation admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. g care. | 0 | None | 0 | 6 | 0 | 6 | View |