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 |
|---|---|---|---|---|---|---|---|---|
| Nebulizers | Subjects will receive a long-acting B2-agonist (LABA; Brovana, twice daily), corticosteroid (ICS; Pulmicort, twice daily), and a short-acting anti-cholinergic (SAMA; Atrovent, three times a day). Nebulizers: Patients treated and discharged on nebulized bronchodilators Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily) Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily) Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day) | 1 | None | 3 | 21 | 0 | 21 | View |
| Dry Powder Inhaler | Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily). Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily) Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily) | 1 | None | 7 | 19 | 0 | 19 | View |