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 |
|---|---|---|---|---|---|---|---|---|
| PFC Stockings | The stocking therapy group will be given PFC shear reducing stockings to wear. PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases. | 7 | None | 30 | 195 | 99 | 195 | View |
| Standard Therapy | Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. | 7 | None | 16 | 186 | 99 | 186 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Amputation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| New foot ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Mechanical fall | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |