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 |
|---|---|---|---|---|---|---|---|---|
| Triathlon CR | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis | 4 | None | 3 | 28 | 0 | 28 | View |
| Triathlon PS | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis | 3 | None | 2 | 30 | 0 | 30 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Uterine Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Epileptic fit | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pressure Stroke | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Total knee replacement | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pleomorphic Adenoma of Salivary Glands | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |