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 |
|---|---|---|---|---|---|---|---|---|
| Sodium Chloride 0.9% | Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas. | 0 | None | 0 | 3 | 0 | 3 | View |
| Intralesional Triamcinolone 10 mg/mL | Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. | 0 | None | 0 | 3 | 0 | 3 | View |
| Intralesional Triamcinolone 20 mg/mL | Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. | 0 | None | 0 | 2 | 0 | 2 | View |
| Intralesional Triamcinolone 40 mg/mL | Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. | 0 | None | 0 | 3 | 0 | 3 | View |