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 |
|---|---|---|---|---|---|---|---|---|
| Spiriva Respimat Group | Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this noninterventional, observational study to collect new real world data (i.e., data under routine medical practice) | 0 | None | 1 | 180 | 0 | 180 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |