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 |
|---|---|---|---|---|---|---|---|---|
| Tiotropium + Olodaterol | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. | 0 | None | 0 | 0 | 0 | 0 | View |
| Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated long-acting beta agonist / inhaled corticosteroid therapy, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. | 0 | None | 0 | 0 | 0 | 0 | View |