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: 2025-12-25 @ 1:12 AM
Ignite Modification Date: 2025-12-25 @ 11:23 PM
NCT ID: NCT00278993
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00278993
Study Brief: Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
E7389 Intravenous 1.4 mg/m2 E7389 intravenous 1.4 mg/m2 on a 3-week course None None 34 108 107 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Febrile Neutropenia None Blood and lymphatic system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Abdominal Pain None Blood and lymphatic system disorders None View
Diarrhea None Blood and lymphatic system disorders None View
Gastrointestinal Hemorrhage None Gastrointestinal disorders None View
Intestinal Obstruction None Gastrointestinal disorders None View
Melena None Gastrointestinal disorders None View
Esophageal Ulcer Hemorrhage None Gastrointestinal disorders None View
Chest Pain None General disorders None View
Edema Peripheral None General disorders None View
Pyrexia None General disorders None View
Suprpubic Pain None General disorders None View
Bradycardia None Cardiac disorders None View
Cardiac Arrest None Cardiac disorders None View
Tachycardia None Cardiac disorders None View
Pharyngitis Streptococcal None Infections and infestations None View
Pneumonia None Infections and infestations None View
Sepsis None Infections and infestations None View
Urinary Tract Infection None Infections and infestations None View
Uriosepsis None Infections and infestations None View
Dehydration None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypovolemia None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Muscular Weakness None Musculoskeletal and connective tissue disorders None View
Pathological Fracture None Musculoskeletal and connective tissue disorders None View
Malignant Neoplasm Progression None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hemiparesis None Nervous system disorders None View
Spinal Cord Compression None Nervous system disorders None View
Confusional State None Psychiatric disorders None View
Bladder Obstruction None Renal and urinary disorders None View
Hematuria None Renal and urinary disorders None View
Renal Colic None Renal and urinary disorders None View
Renal Failure None Renal and urinary disorders None View
Renal Failure Acute None Renal and urinary disorders None View
Prostatic Pain None Reproductive system and breast disorders None View
Alveolitis Allergic None Respiratory, thoracic and mediastinal disorders None View
Chronic Obstructive Pulmonary Disease None Respiratory, thoracic and mediastinal disorders None View
Lung Infiltration None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism None Respiratory, thoracic and mediastinal disorders None View
Swelling Face None Skin and subcutaneous tissue disorders None View
Deep Vein Thrombosis None Vascular disorders None View
Hypertension None Vascular disorders None View
Peripheral Ischemia None Vascular disorders None View
Thrombosis None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Leukopenia None Blood and lymphatic system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Dry Mouth None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Asthenia None General disorders None View
Fatigue None General disorders None View
Mucosal Inflammation None General disorders None View
Edema Peripheral None General disorders None View
Pain None General disorders None View
Pyrexia None General disorders None View
Urinary Tract Infection None Infections and infestations None View
Alanine Aminotransferase Increased None Investigations None View
Aspartate Aminotransferase Increased None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Underweight None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Bone Pain None Musculoskeletal and connective tissue disorders None View
Muscular Weakness None Musculoskeletal and connective tissue disorders None View
Musculoskeletal Chest Pain None Musculoskeletal and connective tissue disorders None View
Musculoskeletal Pain None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Dizziness None Nervous system disorders None View
Dysgeusia None Nervous system disorders None View
Headache None Nervous system disorders None View
Neuropathy None Nervous system disorders None View
Neuropathy Peripheral None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Insomnia None Psychiatric disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Hot Flush None Vascular disorders None View