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 |
|---|---|---|---|---|---|---|---|---|
| Everolimus + Exemestane + Metformin | Exemestane 25 mg by mouth once a day daily for 28, Everolimus 10 mg by mouth once a day daily for 28, days and Metformin upto 1000 mg by mouth twice a day daily for 28 days cycle. | 0 | None | 1 | 22 | 22 | 22 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anorexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| Anemia(grade 2) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| Nausea (grade 2) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| Diarrhea (grade 2) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| AST elevation | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.03) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| ALT elevation | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.03) | View |
| Insomnia(grade 2) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| Rash (grade 2) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| Dyspnea(grade 2) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| Fever(grade 2) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| Generalized muscle weakness(grade 2) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| Vomitting (grade 2) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (4.03) | View |