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: 2025-12-24 @ 5:02 PM
Ignite Modification Date: 2025-12-25 @ 2:42 PM
NCT ID: NCT00326950
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00326950
Study Brief: Phase I Clinical Study of E7389
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 E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m\^2, with planned dose levels of 1.0, 1.4, \& 2.0 mg/m\^2. None None 5 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia None Blood and lymphatic system disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Myelodysplastic Syndrome None Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neuralgia None Nervous system disorders None View
Neuropathy None Nervous system disorders None View
Neuropathy Peripheral None Nervous system disorders None View
Peripheral Sensory Neuropathy None Nervous system disorders None View
Lacrimation Increased None Eye disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Dyspnea Exertional None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Gastritis None Gastrointestinal disorders None View
Gingivitis None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Dry Skin None Skin and subcutaneous tissue disorders None View
Hemorrhage Subcutaneous None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue 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
Musculoskeletal Pain None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Neck Pain None Musculoskeletal and connective tissue disorders None View
Fatigue None General disorders None View
Edema None General disorders None View
Edema Peripheral None General disorders None View
Pain None General disorders None View
Pyrexia None General disorders None View
Alanine Aminotransferase Increased None Investigations None View
Aspartate Aminotransferase Increased None Investigations None View
Blood Albumin Decreased None Investigations None View
Blood Bilirubin Increased None Investigations None View
Blood Calcium Increased None Investigations None View
Blood Chloride Increased None Investigations None View
Blood Cholesterol Decreased None Investigations None View
Blood Cholesterol Increased None Investigations None View
Blood Creatine Phophokinase Increased None Investigations None View
Blood Creatinine Increased None Investigations None View
Blood Glucose Increased None Investigations None View
Blood Lactate Dehydrogenase Increased None Investigations None View
Blood Potassium Decreased None Investigations None View
Blood Sodium Decreased None Investigations None View
Blood Urea Decreased None Investigations None View
Blood Urea Increased None Investigations None View
C-Reactive Protein Increased None Investigations None View
Electrocardiogram QT Prolonged None Investigations None View
Electrocardiogram ST Segment Depression None Investigations None View
Neutrophil Count Increased None Investigations None View
Platelet Count Decreased None Investigations None View
Protein Total Decreased None Investigations None View
Red Blood Cell Count Decreased None Investigations None View
Weight Decreased None Investigations None View
White Blood Cell Count Decreased None Investigations None View
White Blood Cell Count Increased None Investigations None View
Protein Urine Present None Investigations None View
Blood Alkaline Phosphatase Increased None Investigations None View
Tooth Fracture None Injury, poisoning and procedural complications None View
Febrile Neutropenia None Blood and lymphatic system disorders None View
Nasopharyngitis None Infections and infestations None View
Pharyngitis None Injury, poisoning and procedural complications None View
Pneumonia None Infections and infestations None View
Urinary Tract Infection None Infections and infestations None View
Anorexia None Metabolism and nutrition disorders None View
Convulsion None Nervous system disorders None View
Dysgeusia None Nervous system disorders None View
Headache None Nervous system disorders None View
Gamma Glutamyltransferase Increased None Investigations None View
Glucose Urine Present None Investigations None View
Blood Urine Present None Investigations None View
Hemoglobin Decreased None Investigations None View
Lymphocyte Count Decreased None Investigations None View
Neutrophil Count Decreased None Investigations None View