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 |
|---|---|---|---|---|---|---|---|---|
| Combination Drug Therapy | Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles. | None | None | 3 | 74 | 24 | 74 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lung Hemorrhage | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pneumonia with Grade 3 or 4 Neutropenia | None | Infections and infestations | CTCAE (3.0) | View |
| Pneumonia with Normal Absolute Neutrophil Count | None | Infections and infestations | CTCAE (3.0) | View |
| Pneumonitis | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukocytes (total WBC) | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Lymphopenia | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Platelets | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Rash/desquamation | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Constipation | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Edema: limb | None | General disorders | CTCAE (3.0) | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Albumin, serum-low (hypoalbuminemia) | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Calcium, serum-low (hypocalcemia) | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Glucose, serum-high (hyperglycemia) | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Phosphate, serum-low (hypophosphatemia) | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Potassium, serum-low (hypokalemia) | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Sodium, serum-low (hyponatremia) | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dizziness | None | Nervous system disorders | CTCAE (3.0) | View |
| Mood alteration | None | Nervous system disorders | CTCAE (3.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Anemia | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | CTCAE (3.0) | View |
| Nausea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neuropathy: sensory | None | Nervous system disorders | CTCAE (3.0) | View |
| Pain | None | Nervous system disorders | CTCAE (3.0) | View |