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 |
|---|---|---|---|---|---|---|---|---|
| Low Dose AVI-4658 | Low dose of AVI-4658 0.09 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle | 0 | None | 0 | 2 | 2 | 2 | View |
| High Dose AVI-4658 | High dose of AVI-4658 0.9 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle | 0 | None | 0 | 5 | 4 | 5 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bilateral erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Myoglobinuria | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Bilateral oedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Decline in cardiac function | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |