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 |
|---|---|---|---|---|---|---|---|---|
| Women Without HIV or ZIKV | Pregnant women without HIV or ZIKV | 0 | None | 0 | 26 | 0 | 26 | View |
| Infants of Women With HIV Only | Infants of women with HIV infection during pregnancy | 2 | None | 0 | 170 | 0 | 170 | View |
| Infants of Women With ZIKV Only | Infants of women with ZIKV infection during pregnancy | 0 | None | 0 | 0 | 0 | 0 | View |
| Infants of Women With HIV and ZIKV | Infants of women with HIV and ZIKV infection during pregnancy | 0 | None | 0 | 0 | 0 | 0 | View |
| Infants of Women Without HIV or ZIKV | Infants of women without HIV or ZIKV infection during pregnancy | 0 | None | 0 | 25 | 0 | 25 | View |
| Women With HIV and ZIKV | Pregnant women with HIV and ZIKV | 0 | None | 0 | 0 | 0 | 0 | View |
| Women With HIV Only | Pregnant women with HIV only | 1 | None | 0 | 174 | 0 | 174 | View |
| Women With ZIKV Only | Pregnant women with ZIKV only | 0 | None | 0 | 0 | 0 | 0 | View |