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 @ 11:59 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT01142661
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01142661
Study Brief: Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies
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 Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death. None None 7 9 9 9 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
Tachycardia None Cardiac disorders None View
Hematemesis None Gastrointestinal disorders None View
Pneumonia None Infections and infestations None View
Progressive Disease None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Syncope None Nervous system disorders None View
Alcohol Poisoning None Musculoskeletal and connective tissue disorders None View
Small Bowel Obstruction None Gastrointestinal disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia None Blood and lymphatic system disorders None View
Anemia None Blood and lymphatic system disorders None View
Leukopenia None Blood and lymphatic system disorders None View
Splenomegaly None Blood and lymphatic system disorders None View
Thrombocytopenia None Congenital, familial and genetic disorders None View
Tachyarrhythmia None Eye disorders None View
Lacrimation Increased None Eye disorders None View
Photopsia None Eye disorders None View
Vision Blurred None Gastrointestinal disorders None View
Abdominal Distension None Gastrointestinal disorders None View
Abdominal Hernia None General disorders None View
Ascites None Gastrointestinal disorders None View
Gingival Bleeding None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Hypoaesthesia Oral None Gastrointestinal disorders None View
Mouth Ulceration None Investigations None View
Oral Discomfort None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Fatigue None General disorders None View
Peripheral Edema None General disorders None View
Cyst None General disorders None View
Mucosal Inflammation None General disorders None View
Oral Herpes None Infections and infestations None View
Skin Infection None Injury, poisoning and procedural complications None View
Urinary Tract Infection None Infections and infestations None View
Contusion None Injury, poisoning and procedural complications None View
Occult Blood Positive None Investigations None View
Decreased Appetite None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Fluid Retention None Metabolism and nutrition disorders None View
Hypocalcemia 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 Pregnancy, puerperium and perinatal conditions 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
Headache None Nervous system disorders None View
Ataxia None Nervous system disorders None View
Dysaesthesia None Nervous system disorders None View
Neuropathy Peripheral None Nervous system disorders None View
Oropharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Upper Airway Cough Syndrome None Respiratory, thoracic and mediastinal disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Pruritis None Skin and subcutaneous tissue disorders None View
Jaundice None Hepatobiliary disorders None View
Insomnia None Psychiatric disorders None View
Phlebitis None Vascular disorders None View
Phlebitis Superficial None Vascular disorders None View
Vision Impairment None Eye disorders None View
Constipation None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Neutrophil Count Decreased None Investigations None View
Blood Alkaline Phosphatase Increased None Investigations None View
Blood Bilirubin Increased None Investigations None View
Hemoglobin Decreased None Investigations None View
Peripheral Sensory Neuropathy None Nervous system disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View