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 @ 5:40 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT02649868
Description: None
Frequency Threshold: 0
Time Frame: Up to one year post procedure
Study: NCT02649868
Study Brief: LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic 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
Hepatic Tumors Bead Embolization Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure. 3 None 6 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retroperitoneal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sudden hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroparesis postoperative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Administration site lymphadenopathy SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Face edema SYSTEMATIC_ASSESSMENT General disorders None View
Facial pain SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flank pain SYSTEMATIC_ASSESSMENT General disorders None View
Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders None View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Night sweats SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pelvic mass SYSTEMATIC_ASSESSMENT General disorders None View
Biloma SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Medical device site bruise SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Absolute neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood lactate dehydrogenase SYSTEMATIC_ASSESSMENT Investigations None View
International normalized ratio increased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia nervosa SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Confusional state SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Paralysis recurrent laryngeal nerve SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sleep apnea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin papilloma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Procedural haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Subclavian vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View