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 |
|---|---|---|---|---|---|---|---|---|
| Halobetasol Propionate Foam, 0.05% | 24 subjects with stable plaque psoriasis on at least 10% BSA (excluding: face, scalp, groin, axillae, and other intertriginous areas), who fulfilled the inclusion/exclusion criteria were enrolled at multiple study sites in the US and Europe. All subjects were to have a Cosyntropin Stimulation Test (CST) to assess their HPA axis response at Visit 1/Screening initiated between 7 and 9 AM. Enrollment into the treatment phase of the study should have been timed such that the Screening CST was performed a minimum of 20 days before Visit 2/Baseline. At Visit 2/Baseline, eligible subjects with normal adrenal function were eligible to participate in the study. Subjects were instructed to apply HBP Foam, 0.05% to all psoriasis plaques identified at Visit 2/Baseline twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verified the subject's psoriasis had cleared. | 0 | None | 0 | 24 | 7 | 24 | View |