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 |
|---|---|---|---|---|---|---|---|---|
| Erlotinib + Celecoxib | erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression | None | None | 14 | 14 | 14 | 14 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| pharyngocutaneous fistula | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| folliculitis | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| nausea | None | General disorders | CTCAE (3.0) | View |
| bone necrosis | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| trismus | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| mucositis | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dermatitis | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pain | None | General disorders | CTCAE (3.0) | View |
| Fatigue | None | General disorders | CTCAE (3.0) | View |
| Acneiform Rash | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Metabolic (Na, K, Ca) | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| rectal bleeding | None | Gastrointestinal disorders | CTCAE (3.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Mucositis | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dermatitis | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pain | None | General disorders | CTCAE (3.0) | View |
| Xerostomia | None | General disorders | CTCAE (3.0) | View |
| abnormal white blood cell count | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| abnormal hemoglobin count | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Fatigue | None | General disorders | CTCAE (3.0) | View |
| Dry eye | None | Eye disorders | CTCAE (3.0) | View |
| Nausea | None | General disorders | CTCAE (3.0) | View |
| Acneiform rash | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Metabolic (Na, K, Ca) | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Elevated Liver Function Tests | None | Hepatobiliary disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Rectal bleeding | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Conjuncitivitis | None | Eye disorders | CTCAE (3.0) | View |