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 |
|---|---|---|---|---|---|---|---|---|
| Vorinostat Prophylaxis | Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant. Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops. The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose. Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients. | None | None | 31 | 58 | 51 | 58 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anorexia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Edema: Limb | None | General disorders | CTCAE (3.0) | View |
| Infection | None | Infections and infestations | CTCAE (3.0) | View |
| Pulmonary Hypertension | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Relapse | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| Graft Versus Host Disease | None | Immune system disorders | CTCAE (3.0) | View |
| Thrombosis/Thrombus/Embolism | None | Vascular disorders | CTCAE (3.0) | View |
| Hemmorrhoids | None | Gastrointestinal disorders | CTCAE (3.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyponatremia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Infection | None | Infections and infestations | CTCAE (3.0) | View |
| Leukocytes (White Blood Cells Decreased) | None | Investigations | CTCAE (3.0) | View |
| Lymphopenia | None | Investigations | CTCAE (3.0) | View |
| Neutrophils Decreased | None | Investigations | CTCAE (3.0) | View |
| Platelets Decreased | None | Investigations | CTCAE (3.0) | View |
| Alanine Aminotransferase Increased | None | Investigations | CTCAE (3.0) | View |
| Hemoglobin | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypocalcemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |