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 |
|---|---|---|---|---|---|---|---|---|
| Ceftaroline Fosamil | IV Ceftaroline fosamil 15 mg/kg (or 600 mg if \> 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour). The dose may vary with age. Ceftaroline Fosamil: IV Ceftaroline fosamil 15 mg/kg (or 600 mg if \> 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) for children 2 years of age - 17 years of age (inclusive). IV Ceftarloine Fosamil 10 mg/kg infused 120 (± 10) minutes q8h (± 1 hour) for children 1 years of age - less than 2 years of age (inclusive). | 0 | None | 1 | 11 | 0 | 11 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| progression of infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |