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 |
|---|---|---|---|---|---|---|---|---|
| Observation Group | Zoledronate: administrated depending on increase in s-CTX (above 1.26 ug/l), decrease in BMD (more than 5% at any site), or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 6. Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site. | 0 | None | 4 | 21 | 20 | 21 | View |
| 6-month Group | Zoledronate: administrated at baseline. Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site. | 0 | None | 0 | 20 | 18 | 20 | View |
| 9-months Group | Zoledronate: administrated depending on increase in s-CTX (above 1.26 ug/l) or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 3. Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site. | 0 | None | 1 | 20 | 18 | 20 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cancer | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Flu-like symptoms after ZOL treatment | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Infection (unspecified) + Musculoskeletal symptoms | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |