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 |
|---|---|---|---|---|---|---|---|---|
| Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin | Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h. Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h. | 0 | None | 0 | 53 | 8 | 53 | View |
| Placebo + Imipenem/Cilastatin | Placebo: Matching 1g IV solution. Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h. | 0 | None | 0 | 27 | 3 | 27 | View |