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 |
|---|---|---|---|---|---|---|---|---|
| Matrifen® | Patients included and treated with at least one application of Matrifen® | None | None | 80 | 5308 | 0 | 5308 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Cardiovascular disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Metastases to liver | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Metastases to bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Metastasis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Dementia Alzheimer's type | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Hospitalisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (12.1) | View |
| Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (12.1) | View |
| Amputation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (12.1) | View |
| Prosthesis implantation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (12.1) | View |