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 |
|---|---|---|---|---|---|---|---|---|
| A1 - Combination Chemotherapy Without Interferon | combination chemotherapy without interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle | None | None | 14 | 62 | 12 | 62 | View |
| A2 - Combination Chemotherapy With Interferon | combination chemotherapy with interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle Interferon Alfa-2b: α2b 5 MUI three times per week | None | None | 27 | 67 | 25 | 67 | View |
| B1 - Single Agent Dacarbazine Without Interferon | single agent dacarbazine without interferon Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle | None | None | 8 | 71 | 16 | 71 | View |
| B2 - Single Agent Dacarbazine Plus Interferon | single agent dacarbazine plus interferon Dacarbazine: 900 mg / m2 every 3 weeks Interferon Alfa-2b: α2b 5 MUI three times per week | None | None | 10 | 52 | 13 | 52 | View |