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 |
|---|---|---|---|---|---|---|---|---|
| Cohort 1:Women With HIV Sexually Active | Women with perinatally acquired HIV aged 18 or over who are sexually active Human papillomavirus testing: HPV test from cervical sample using Cepheid GeneXpert HPV Cervical cytology: Cervical cytology HPV serology: HPV type specific serology using ELISA from serum samples | 0 | None | 0 | 54 | 0 | 54 | View |
| Cohort 2: Women With HIV Not Sexually Active | Women with perinatally acquired HIV aged 18 or over who are not sexually active HPV serology: HPV type specific serology using ELISA from serum samples | 0 | None | 0 | 3 | 0 | 3 | View |