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:
2025-12-24 @ 12:48 PM
Ignite Modification Date:
2025-12-25 @ 12:15 PM
NCT ID:
NCT00330161
Description:
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
Frequency Threshold:
5
Time Frame:
Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
Study:
NCT00330161
Study Brief:
Vorinostat in Treating Patients With Progressive Metastatic Prostate Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment (Vorinostat) | Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity. Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels. | None | None | 8 | 29 | 29 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonitis | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Proctitis | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Skin Infection | None | Infections and infestations | CTCAE (3.0) | View |
| Thrombosis | None | Vascular disorders | CTCAE (3.0) | View |
| Vomiting | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Arrhythmia | None | Cardiac disorders | CTCAE (3.0) | View |
| Abdominal Pain | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Back Pain | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Creatinine Increased | None | Investigations | CTCAE (3.0) | View |
| Dehydration | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hemorrhage Urinary Tract | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Infection, Bone (Osteomyelitis) | None | Infections and infestations | CTCAE (3.0) | View |
| Nausea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain | None | General disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Distention | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Alkaline Phosphatase Increased | None | Investigations | CTCAE (3.0) | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Anorexia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Bone Pain | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Constipation | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry Mouth | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dyspepsia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dysphagia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Edema Limbs | None | General disorders | CTCAE (3.0) | View |
| Fatigue | None | General disorders | CTCAE (3.0) | View |
| Fever | None | General disorders | CTCAE (3.0) | View |
| Hot Flashes | None | Vascular disorders | CTCAE (3.0) | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Leukopenia (White Blood Cells Decreased) | None | Investigations | CTCAE (3.0) | View |
| Muscle Weakness | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain | None | General disorders | CTCAE (3.0) | View |
| Platelet Count Decreased | None | Investigations | CTCAE (3.0) | View |
| Urinary Frequency | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Activated Partial Thromboplastin Time Prolonged | None | Investigations | CTCAE (3.0) | View |
| Alanine Aminotransferase Increased | None | Investigations | CTCAE (3.0) | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Aspartate Aminotransferase Increased | None | Investigations | CTCAE (3.0) | View |
| Bladder Hemorrhage | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Erectile Dysfunction | None | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Hearing Loss | None | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Anemia | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperkalemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypernatremia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypersensitivity | None | General disorders | CTCAE (3.0) | View |
| Hypoalbuminemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypocalcemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypokalemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyponatremia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| INR Increased | None | Investigations | CTCAE (3.0) | View |
| Joint Pain | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Lymphopenia | None | Investigations | CTCAE (3.0) | View |
| Mucositis Oral | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain in Extremity | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Taste Alteration | None | Nervous system disorders | CTCAE (3.0) | View |
| Vomiting | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Weight Decreased | None | Investigations | CTCAE (3.0) | View |