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 C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted) | All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18. | 0 | None | 0 | 10 | 0 | 10 | View |
| Treatment A: 200 mg LOXO-305 (Fasted) | All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2). | 0 | None | 0 | 10 | 0 | 10 | View |
| Treatment B: 200 mg LOXO-305 (Fed) | All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1). | 0 | None | 0 | 10 | 1 | 10 | View |
| Treatment C: 40 mg Omeprazole (Fasted) | All participants who received single oral dose of 40 mg Omeprazole (Fasted) on Day 15 to 17. | 0 | None | 0 | 10 | 0 | 10 | View |