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
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
NCT ID:
NCT00810394
Description:
None
Frequency Threshold:
2
Time Frame:
Up to 2 years
Study:
NCT00810394
Study Brief:
Sorafenib in Treating Patients With Advanced Malignant Solid Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sorafenib | Dose Re-Escalation Following a Dose Reduction Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable. | None | None | 19 | 50 | 42 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchopulmonary Hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lower Gastrointestinal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ataxia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| INR | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Skin Reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hand and Foot Syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Weight Loss | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hand Foot Skin Reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pulmonary Hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Alkaline Phosphatase | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| AST | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Bicarbonate, Serum | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Muscle Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Mood Alteration | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Voice Changes | SYSTEMATIC_ASSESSMENT | General disorders | None | View |