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 |
|---|---|---|---|---|---|---|---|---|
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL): 1. prior to any treatment; 2. following AD and prior to RT; and 3. following the end of RT (1-3 months afterwards). The quantification of CTC in blood samples will be done with the CellSearch® system. | 7 | None | 7 | 65 | 15 | 65 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Head and neck cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Gastric adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Postoperative of colon volvulus | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Ureter cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Urethral estenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Pneumomia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Bronchoaspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Gastric GIST | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |