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 |
|---|---|---|---|---|---|---|---|---|
| Treatment Period 1: Microgynon Group | Participants received a single dose of Microgynon (0.03 mg EE/0.15 mg LNG) on Day 1 of Treatment Period 1. | 0 | None | 0 | 20 | 4 | 20 | View |
| Treatment Period 2: GSK3036656 Group | Participants received GSK3036656 40 mg on Day 4, followed by GSK3036656 20 mg once daily from Day 5 to Day 14 during Treatment Period 2. | 0 | None | 0 | 19 | 1 | 19 | View |
| Treatment Period 3: Microgynon + GSK3036656 Group | Participants received Microgynon (EE/LNG) along with GSK3036656 20 mg on Day 15, followed by GSK3036656 20 mg once daily from Day 16 to Day 17 during Treatment Period 3. | 0 | None | 0 | 18 | 1 | 18 | View |