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 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
NCT ID:
NCT00919035
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Study:
NCT00919035
Study Brief:
Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Torisel | Single Agent Temsirolimus (Torisel®) Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion | None | None | 11 | 21 | 21 | 21 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Acute Arterial ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| intracranial bleed | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| transient ischemic attack | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| weakness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| eyes watery | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| edema | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| fall | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| gynecomastia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hypercholesteremia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hypercalcemia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hyperglycemia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| albumin low | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| alkaline phosphatase | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Aspartate Aminotransferase elevated | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Alanine Aminotransferase high | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| bruising | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| hypoglycemia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hypocalcemia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hypokalemia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hyponatremia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hypophosphatemia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hemorrhoids | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| lightheadedness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| leukopenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| lymphopenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| mucositis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| protein low | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| rectal fissure | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| taste changes | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| vomting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| weakness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| creatinine high | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| dyspnea on exertion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| eyes dry | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |