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 |
|---|---|---|---|---|---|---|---|---|
| Study Population | Postmenopausal women (postmenopausal for at least 2 years) and men above 50 years, who had been treated with ALN for at least five years and had a THBMD T-score \> -2.5 and LSBMD (L1-L4) T-score \> -4. We excluded patients with any low-energy fracture within the previous 5 years during ALN treatment (not including fingers, toes, or skull), low-energy VFx or hip fracture at any time, on-going treatment with systemic glucocorticoids, metabolic bone disease, hormone replacement therapy, cancer and other conditions affecting bone metabolism. | 0 | None | 7 | 142 | 68 | 142 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cancer | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Arrhythmia, acute myocardial infarction, hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cataract, glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Lower urinary symptoms, infection and kidney stones | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Arthralgia, osteoarthritis, back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Upper and lower respiratory tract infection, pneumonia, bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |