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 |
|---|---|---|---|---|---|---|---|---|
| PET Imaging With Tc-94m Sestamibi | Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging. Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan | 0 | None | 0 | 12 | 8 | 12 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Calcium, serum-high (hypercalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Low Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Low Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Magnesium, serum-high (hypermagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Magnesium, serum-low (hypomagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Low Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Pain::Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Low Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Potassium, serum-low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Sodium, serum-low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Uric acid, serum-high (hyperuricemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |