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 A: CIS (Either Study) | Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\]. BCG in Combination with N-803: BCG in Combination with N-803 | 0 | None | 0 | 0 | 0 | 0 | View |
| Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study) | Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease BCG in Combination with N-803: BCG in Combination with N-803 | 0 | None | 0 | 0 | 0 | 0 | View |
| Cohort C: CIS (QUILT-3.032) | Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\]. N-803 alone: N-803 alone | 0 | None | 0 | 0 | 0 | 0 | View |