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 | Cohort 1 were planned to receive escalating doses of AMG 330 via continuous intravenous infusion (cIV) from Day 1 of Cycle 1 (Cycle 1 was 77 days; subsequent cycles were 57 days) for up to 6 months. The starting dose of AMG 330 was 10 μg/day, increasing up to a maximum of 600 μg/day. Cohort 1 were planned to receive 8 mg of dexamethasone 1 hour prior to each step dose of AMG 330. If the participant did not experience a dose-limiting toxicity (DLT) by Day 14, they then were also planned to receive 200 mg of pembrolizumab once every 3 weeks (Q3W) by a 30-minute intravenous (IV) infusion from Day 15 onwards. At the end of Cycle 1, there was a planned 1-week interval without administration of AMG 330, known as the infusion-free period. | 1 | None | 0 | 0 | 0 | 0 | View |