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 |
|---|---|---|---|---|---|---|---|---|
| SOF+DAC+PEG | Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C | 0 | None | 0 | 50 | 0 | 50 | View |
| SOF+DAC, DOT | Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C | 0 | None | 0 | 50 | 0 | 50 | View |
| SOF+DAC, Standard | Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses) Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C | 0 | None | 0 | 50 | 0 | 50 | View |