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 |
|---|---|---|---|---|---|---|---|---|
| Oral Viscous Budesonide (OVB) | Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily. Oral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily Placebo inhaler: Placebo inhaler - 4 puffs twice daily | 0 | None | 0 | 65 | 10 | 65 | View |
| Active Fluticasone MDI | Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB. Fluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily) Placebo slurry: Slurry of sucralose - 4 mL twice daily | 0 | None | 1 | 64 | 15 | 64 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Food impaction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| esophageal candidiasis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| sore throat | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| chest pain | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |