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 |
|---|---|---|---|---|---|---|---|---|
| Unrelated Donor Umbilical Cord Transplant | Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood | None | None | 9 | 16 | 16 | 16 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood/Bone Marrow, other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Death not assoc w CTCAE term- Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Death not assoc w CTCAE term- Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Sodium, low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Bicarbonate, serum-low | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Calcium, high (hypercalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Glucose, high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Magnesium, high (hypermagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Phosphate, low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Potassium, high (hyperkalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Potassium, low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Partial thromboplastin time (PTT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Sodium, low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |