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 |
|---|---|---|---|---|---|---|---|---|
| 2g/Day Eicosapentanoic Acid (EPA) | Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months Endoscopy: With video and photographs at baseline and month 6. Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy). | None | None | 3 | 29 | 25 | 29 | View |
| Placebo | Medium chain triglycerides 2 capsules twice daily for six months. Endoscopy: With video and photographs at baseline and month 6. Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy). | None | None | 0 | 29 | 25 | 29 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Endocrine disorders | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| General disorders | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Immune system disorders | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| metabolism and nutritional disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neoplasms benign, malignant and unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Reproductive system and breast disorders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Vascular disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |