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 @ 2:12 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT00706095
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00706095
Study Brief: Study Of Eribulin (E7389) In Patients With Advanced Solid Tumors And Normal Or Reduced Hepatic Function As Per Child-Pugh System
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 1.4 mg/m^2 E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m\^2 for normal hepatic function. None None 1 6 6 6 View
E7389 1.1 mg/m^2 E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m\^2 for mild hepatic impairment (Child-Pugh A) None None 4 7 7 7 View
E7389 0.7 mg/m^2 E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m\^2 for moderate hepatic impairment (Child-Pugh B) None None 3 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Duodenal Obstruction None Gastrointestinal disorders None View
Gastrointestinal Hemorrhage None Gastrointestinal disorders None View
Ileus None Gastrointestinal disorders None View
Esophageal Varices Hemorrhage None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Blood Bilirubin Increased None Investigations None View
Blood Creatinine Increased None Investigations None View
Dehydration None Metabolism and nutrition disorders None View
Malignant Ascites None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant Neoplasm Progression None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Rib Fracture None Injury, poisoning and procedural complications None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Confusional State None Psychiatric disorders None View
Pleural Effusion None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Abdominal Pain Upper None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Abdominal Distention None Gastrointestinal disorders None View
Dry Mouth None Gastrointestinal disorders None View
Hematochezia None Gastrointestinal disorders None View
Melena None Gastrointestinal disorders None View
Fatigue None General disorders None View
Edema Peripheral None General disorders None View
Pyrexia None General disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Muscle Spasms None Musculoskeletal and connective tissue disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Muscular Weakness None Musculoskeletal and connective tissue disorders None View
Muscular Stiffness None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Weight Decreased None Investigations None View
Blood Bilirubin Increased None Investigations None View
Aspartate Aminotransferase Increased None Investigations None View
Blood Creatinine Increased None Investigations None View
Peripheral Sensory Neuropathy None Nervous system disorders None View
Dysgeusia None Nervous system disorders None View
Headache None Nervous system disorders None View
Paresthesia None Nervous system disorders None View
Peripheral Motor Neuropathy None Nervous system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Anemia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Anorexia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition 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
Pharyngolaryngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Hypotension None Vascular disorders None View
Confusional State None Psychiatric disorders None View