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 |
|---|---|---|---|---|---|---|---|---|
| Dasatinib | 50-100mg po bid | None | None | 10 | 31 | 30 | 31 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pain | None | General disorders | CTCAE (3.0) | View |
| Pain, back | None | General disorders | None | View |
| Pain, extrimity limb | None | General disorders | CTCAE (3.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Anorexia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Syncope | None | General disorders | CTCAE (3.0) | View |
| Edema, limb | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| AST | None | Hepatobiliary disorders | CTCAE (3.0) | View |
| Pleural Effusion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pain, chest/thorax | None | General disorders | None | View |
| Pneumonitis | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Thrombosis | None | Blood and lymphatic system disorders | None | View |
| hyponatremia | None | General disorders | CTCAE (3.0) | View |
| infection | None | Infections and infestations | None | View |
| diarrhea | None | Gastrointestinal disorders | None | View |
| fever | None | General disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| mucositis | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| rhinitis | None | General disorders | CTCAE (3.0) | View |
| neuropathy sensory | None | Nervous system disorders | CTCAE (3.0) | View |
| plueral effusion | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| anorexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| fatigue | None | General disorders | CTCAE (3.0) | View |
| fever: non-neutropenic | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Flushing | None | General disorders | CTCAE (3.0) | View |
| insomnia | None | General disorders | CTCAE (3.0) | View |
| diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| constipation | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| nausea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| vomiting | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| cough | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| dyspnea | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| pneumonitis | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| paricardial effusion | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| pain: abdomen | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| pain: bone | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| pain: chestwall | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| pain:extremity | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| pain: headache | None | Nervous system disorders | CTCAE (3.0) | View |
| pain:joint | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| pain: muscle | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| elevated ALT | None | Hepatobiliary disorders | CTCAE (3.0) | View |
| elevated AST | None | Hepatobiliary disorders | CTCAE (3.0) | View |
| hyponatremia | None | Investigations | CTCAE (3.0) | View |
| thrombocytopenia | None | Investigations | CTCAE (3.0) | View |
| DVT | None | Vascular disorders | CTCAE (3.0) | View |
| edema:facial | None | General disorders | CTCAE (3.0) | View |
| edema: extremity | None | General disorders | CTCAE (3.0) | View |
| cellulitis | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| rash | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |