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 @ 3:27 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT00268905
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00268905
Study Brief: A Dose-Finding Study of E7389 in Combination With Carboplatin in Patients With Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5 Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors None None 18 43 42 43 View
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6 Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors None None 5 9 9 9 View
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6 Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC) None None 8 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Pancytopenia None Blood and lymphatic system disorders None View
Leukopenia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Cardiac Failure None Cardiac disorders None View
Coronary Artery Disease None Cardiac disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Abdominal Pain Upper None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Small Intestinal Obstruction None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Ascites None Gastrointestinal disorders None View
Gastrointestinal Hemorrhage None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Asthenia None General disorders None View
Non-Cardiac Chest Pain None General disorders None View
Pain None General disorders None View
Pyrexia None General disorders None View
Infection None Infections and infestations None View
Urosepsis None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Radius Fracture None Injury, poisoning and procedural complications None View
Femoral Neck Fracture None Injury, poisoning and procedural complications None View
Oral Intake Reduced None Metabolism and nutrition disorders None View
Anorexia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Neck Pain None Musculoskeletal and connective tissue disorders None View
Pain in Extremity None Musculoskeletal and connective tissue disorders None View
Malignant Neoplasm Progression None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral Hemorrhage None Nervous system disorders None View
Headache None Nervous system disorders None View
Sensorimotor Disorder None Nervous system disorders None View
Spinal Cord Compression None Nervous system disorders None View
Syncope None Nervous system disorders None View
Syringomyelia None Nervous system disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Hemoptysis None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism None Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion None Respiratory, thoracic and mediastinal disorders None View
Deep Vein Thrombosis None Vascular disorders None View
Febrile Neutropenia None Blood and lymphatic system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Cerebral Ischemia None Nervous system disorders None View
Renal Failure Acute None Renal and urinary disorders None View
Renal Vein Thrombosis None Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia None Ear and labyrinth 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
Febrile Neutropenia None Blood and lymphatic system disorders None View
Cardiac Failure None Cardiac disorders None View
Coronary Artery Disease None Cardiac disorders None View
Sinus Tachycardia None Cardiac disorders None View
Tachycardia None Cardiac disorders None View
Conjunctival Hyperaemia None Eye disorders None View
Abdominal Distention None Gastrointestinal disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None General disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Abdominal Pain Upper None Gastrointestinal disorders None View
Ascites None Gastrointestinal disorders None View
Dry Mouth None Gastrointestinal disorders None View
Gastrointestinal Hemorrhage None Gastrointestinal disorders None View
Proctalgia None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Frequent Bowel Movements None Gastrointestinal disorders None View
GI Reflux Disease None Gastrointestinal disorders None View
Melena None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Tooth Loss None Gastrointestinal disorders None View
Gingival Pain None Gastrointestinal disorders None View
Hemorrhoidal Hemorrhage None Gastrointestinal disorders None View
Fatigue None General disorders None View
Performance Status Decreased None Hepatobiliary disorders None View
Catheter Site Pain None General disorders None View
Gait Disturbance None General disorders None View
Edema Peripheral None General disorders None View
Asthenia None General disorders None View
Axillary Pain None General disorders None View
Chills None General disorders None View
Extravasation None Hepatobiliary disorders None View
Non-Cardiac Chest Pain 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
Infusion Site Infection None Infections and infestations None View
Localised Infection None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Candidiasis None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Infection None Infections and infestations None View
Oral Candidiasis None Infections and infestations None View
Pneumonia None Nervous system disorders None View
Excoriation None Injury, poisoning and procedural complications None View
Femural Neck Fracture None Injury, poisoning and procedural complications None View
Blood Lactate Dehydrogenase Increased None Metabolism and nutrition disorders None View
Weight Decreased None Investigations None View
Alanine Aminotransferase Increased None Investigations None View
Aspartate Aminotransferase Increased None Investigations None View
Blood Alkaline Phosphatase Increased None Investigations None View
Breath Sounds Abnormal None Investigations None View
Neutrophil Count Decreased None Investigations None View
Hemoglobin Decreased None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypomagnesemia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Decreased Appetite None Metabolism and nutrition disorders None View
Hypercalcemia None Metabolism and nutrition disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Oral Intake Reduced None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Muscle Spasms None Musculoskeletal and connective tissue disorders None View
Muscular Weakness None Musculoskeletal and connective tissue disorders None View
Musculoskeletal Pain None Musculoskeletal and connective tissue disorders None View
Myalgia None Nervous system disorders None View
Neck Pain None Musculoskeletal and connective tissue disorders None View
Pain in Extremity None Musculoskeletal and connective tissue disorders None View
Flank Pain None Musculoskeletal and connective tissue disorders None View
Pain in Jaw None Musculoskeletal and connective tissue disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Groin Pain None Musculoskeletal and connective tissue disorders None View
Musculoskeletal Chest Pain 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
Hypoaesthesia None Nervous system disorders None View
Neuropathy Peripheral None Nervous system disorders None View
Ageusia None Nervous system disorders None View
Amnesia None Pregnancy, puerperium and perinatal conditions None View
Areflexia None Nervous system disorders None View
Hypogeusia None Nervous system disorders None View
Insomnia None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Restless Leg Syndrome None Pregnancy, puerperium and perinatal conditions None View
Cerebral Ischemia None Nervous system disorders None View
Dysarthria None Nervous system disorders None View
Neuropathy None Nervous system disorders None View
Dysuria None Renal and urinary disorders None View
Renal Failure Acute None Renal and urinary disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Skin and subcutaneous tissue disorders None View
Pharyngolaryngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion None Respiratory, thoracic and mediastinal disorders None View
Dysphonia None Skin and subcutaneous tissue disorders None View
Dyspnea Exertional None Respiratory, thoracic and mediastinal disorders None View
Hemoptysis None Respiratory, thoracic and mediastinal disorders None View
Hiccups None Respiratory, thoracic and mediastinal disorders None View
Productive Cough None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Congestion None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Edema None Respiratory, thoracic and mediastinal disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Erythema None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Facial Wasting None Skin and subcutaneous tissue disorders None View
Pain in Skin None Skin and subcutaneous tissue disorders None View
Rash Poplar None Skin and subcutaneous tissue disorders None View
Rash Pruritic None Skin and subcutaneous tissue disorders None View
Pruritis None Skin and subcutaneous tissue disorders None View
Deep Vein Thrombosis None Vascular disorders None View
Hematoma None Vascular disorders None View
Hypotension None Vascular disorders None View
Flushing None Vascular disorders None View
Phlebitis None Vascular disorders None View