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 |
|---|---|---|---|---|---|---|---|---|
| Cephazolin | Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose No adverse effect | None | None | 0 | 98 | 0 | 98 | View |
| Gentamicin | Gentamicin arm: application of 80 mg gentamycin topically Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose No adverse effect | None | None | 0 | 87 | 0 | 87 | View |
| Gentamicin+ Cefazolin Sodium | Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose No adverse effect | None | None | 0 | 91 | 0 | 91 | View |