Adverse Events Module

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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: 2025-12-26 @ 10:19 PM
Ignite Modification Date: 2025-12-26 @ 10:19 PM
NCT ID: NCT00584012
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00584012
Study Brief: A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With 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
Dose Esclation Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor. Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2. 4 None 1 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiovascular (Arrhythmia) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Kidney Stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Amylase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hemmorrhage, nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain, scalp SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased bicarbonate SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain, shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing, face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection with normal ANC SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Occular/visual, peripheral light pulsing SYSTEMATIC_ASSESSMENT Eye disorders None View
Elevated CPK SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated ALT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated AST SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dyspenea on exertion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal pain, cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT General disorders None View
Pain, ankle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decreased WBC SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypersensitivity reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Pain/tenderness, periorbital region SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain/cramping, leg SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain, hands SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypercholesterolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain, oral cavity SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Koilonychia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dyspepsia/heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated Alkaline phosphatase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mood alteration, depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Decreased appetite, anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness/lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal distention SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain, back SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain, chest (muscular) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Decubitus skin breakdown, gluteal folds SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain, neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fracture, iliac wing SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weight gain SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain, chest/thoracic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash, facial SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash, palmar SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
UTI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Joint achiness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain, knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastric reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urine color change SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased netrophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain, hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View