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 @ 9:24 PM

Ignite Modification Date: 2025-12-25 @ 7:09 PM

NCT ID: NCT00100932

Description: None

Frequency Threshold: 5

Time Frame: None

Study: NCT00100932

Study Brief: Phase II Study Of E7389, Halichondrin B Analogue, In Patients With Advanced Non-Small Cell Lung Cancer, NSCLC, Who Progressed During Or After Platinum-Based Doublet 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 28 Day Cycle	E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.	None	None	33	77	77	77	View
E7389 21 Day Cycle	E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.	None	None	11	26	26	26	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Febrile Neutropenia	None	Blood and lymphatic system disorders	None	View
Neutropenia	None	Blood and lymphatic system disorders	None	View
Pancytopenia	None	Blood and lymphatic system disorders	None	View
Cardiac Tamponade	None	Cardiac disorders	None	View
Abdominal Pain	None	Gastrointestinal disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Diarrhea	None	Gastrointestinal disorders	None	View
Diverticular Perforation	None	Gastrointestinal disorders	None	View
Gastritis	None	Gastrointestinal disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Stomatitis	None	Gastrointestinal disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Asthenia	None	General disorders	None	View
Chest Pain	None	General disorders	None	View
Disease Progression	None	General disorders	None	View
Pain	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Cellulitis	None	Infections and infestations	None	View
Neutropenic Sepsis	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Pyrothorax	None	Infections and infestations	None	View
Sepsis	None	Infections and infestations	None	View
Blood Pressure Systolic Inspiratory Decreased	None	Investigations	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Hyponatremia	None	Metabolism and nutrition disorders	None	View
Malignant Neoplasm Progression	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Metastases to Central Nervous System	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Metastasis	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Coordination Abnormal	None	Nervous system disorders	None	View
Dysarthria	None	Nervous system disorders	None	View
Neuropathy Peripheral	None	Nervous system disorders	None	View
Status Epilepticus	None	Nervous system disorders	None	View
Hallucinations, Visual	None	Psychiatric disorders	None	View
Mental Status Changes	None	Psychiatric disorders	None	View
Dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
Hemoptysis	None	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleural Effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary Embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Arrest	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Distress	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Deep Vein Thrombosis	None	Vascular disorders	None	View
Hypotension	None	Vascular disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	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
Atrial Fibrillation	None	Cardiac disorders	None	View
Tachycardia	None	Cardiac disorders	None	View
Abdominal Pain	None	Gastrointestinal disorders	None	View
Abdominal Pain Upper	None	Gastrointestinal disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Diarrhea	None	Gastrointestinal disorders	None	View
Dry Mouth	None	Gastrointestinal disorders	None	View
Dysphagia	None	Gastrointestinal disorders	None	View
Dyspepsia	None	Gastrointestinal disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Stomatitis	None	Gastrointestinal disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Asthenia	None	General disorders	None	View
Chest Pain	None	General disorders	None	View
Chills	None	General disorders	None	View
Fatigue	None	General disorders	None	View
Gait Disturbance	None	General disorders	None	View
Mucosal Inflammation	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
Bronchitis	None	Infections and infestations	None	View
Candidiasis	None	Infections and infestations	None	View
Herpes Zoster	None	Infections and infestations	None	View
Oral Candidiasis	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Sinusitis	None	Infections and infestations	None	View
Upper Respiratory Tract Infection	None	Infections and infestations	None	View
Urinary Tract Infection	None	Infections and infestations	None	View
Excoriation	None	Injury, poisoning and procedural complications	None	View
Alanine Aminotransferase Increased	None	Investigations	None	View
Breath Sounds Abnormal	None	Investigations	None	View
Weight Decreased	None	Investigations	None	View
Anorexia	None	Metabolism and nutrition disorders	None	View
Decreased Appetite	None	Gastrointestinal disorders	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Hyperglycemia	None	Gastrointestinal disorders	None	View
Hypokalemia	None	Metabolism and nutrition disorders	None	View
Hypomagnesemia	None	Metabolism and nutrition disorders	None	View
Hyponatremia	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
Flank Pain	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 Chest Pain	None	Musculoskeletal and connective tissue disorders	None	View
Myalgia	None	Musculoskeletal and connective tissue disorders	None	View
Pain in Extremity	None	Musculoskeletal and connective tissue disorders	None	View
Shoulder 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	None	Nervous system disorders	None	View
Neuropathy Peripheral	None	Nervous system disorders	None	View
Paraesthesia	None	Nervous system disorders	None	View
Peripheral Sensory Neuropathy	None	Nervous system disorders	None	View
Somnolence	None	Nervous system disorders	None	View
Anxiety	None	Psychiatric disorders	None	View
Confusional State	None	Psychiatric disorders	None	View
Depression	None	Psychiatric disorders	None	View
Insomnia	None	Psychiatric disorders	None	View
Pollakiuria	None	Renal and urinary disorders	None	View
Cough	None	Respiratory, thoracic and mediastinal disorders	None	View
Dysphonia	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
Hemoptysis	None	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
Pharyngolaryngeal Pain	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleural Effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary Embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Rales	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Rhinitis Allergic	None	Respiratory, thoracic and mediastinal disorders	None	View
Rhinorrhea	None	Respiratory, thoracic and mediastinal disorders	None	View
Rhonchi	None	Respiratory, thoracic and mediastinal disorders	None	View
Wheezing	None	Respiratory, thoracic and mediastinal disorders	None	View
Alopecia	None	Skin and subcutaneous tissue disorders	None	View
Night Sweats	None	Skin and subcutaneous tissue disorders	None	View
Rash	None	Skin and subcutaneous tissue disorders	None	View
Deep Vein Thrombosis	None	Vascular disorders	None	View
Hypotension	None	Vascular disorders	None	View
Phlebitis	None	Vascular disorders	None	View