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 |
|---|---|---|---|---|---|---|---|---|
| Sotorasib Alone | On Day 1, participants received 960 mg sotorasib (8 x 120 mg tablets) administered orally with 240 mL of water after an overnight fast of at least 10 hours. | 0 | None | 0 | 16 | 0 | 16 | View |
| Omeprazole Alone | On Days 4 to 8, participants received 40 mg omeprazole (delayed release capsule) administered orally with 240 mL of water once daily (QD) after an overnight fast of at least 10 hours. | 0 | None | 0 | 16 | 2 | 16 | View |
| Omeprazole Co-administered With Sotorasib | On Day 9, participants received 40 mg omeprazole (delayed release capsule) followed by 960 mg sotorasib (8 x 120 mg tablets) administered orally within 5 minutes with 240 mL of an acidic beverage after an overnight fast of at least 10 hours. | 0 | None | 0 | 14 | 0 | 14 | View |