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 |
|---|---|---|---|---|---|---|---|---|
| Interferon | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein | 0 | None | 0 | 30 | 0 | 30 | View |
| Interferon Daily | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein | 0 | None | 0 | 28 | 0 | 28 | View |
| Control | All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy | 0 | None | 0 | 20 | 0 | 20 | View |