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 |
|---|---|---|---|---|---|---|---|---|
| Cefuroxime Axetil | Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily. At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture. | None | None | 0 | 140 | 21 | 140 | View |
| Controls | patients' family members or friends without a history of Lyme disease | None | None | 0 | 259 | 0 | 259 | View |
| Doxycycline | Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily. At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture. | None | None | 0 | 145 | 21 | 145 | View |