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 @ 7:24 PM
Ignite Modification Date: 2025-12-25 @ 5:04 PM
NCT ID: NCT00482703
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00482703
Study Brief: A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Total None None None 10 23 23 23 View
Dasatinib 100 mg Once-daily (QD) Starting Dose Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity. None None 4 11 11 11 View
Dasatinib 50 mg Twice-daily (BID) Starting Dose Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity. None None 6 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Enterocolitis None Gastrointestinal disorders None View
Gastrointestinal haemorrhage None Gastrointestinal disorders None View
Pyrexia None General disorders None View
Pneumonia None Infections and infestations None View
Gastroenteritis viral None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Glucose tolerance impaired None Metabolism and nutrition disorders None View
Myelodysplastic syndrome None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Interstitial lung disease None Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia None Blood and lymphatic system disorders None View
Iron deficiency anaemia None Blood and lymphatic system disorders None View
Conjunctivitis None Eye disorders None View
Conjunctivitis allergic None Eye disorders None View
Retinopathy None Eye disorders None View
Irritable bowel syndrome None Gastrointestinal disorders None View
Oedema mouth None Gastrointestinal disorders None View
Stomach discomfort None Gastrointestinal disorders None View
Gastric dysplasia None Gastrointestinal disorders None View
Gastroenteritis None Infections and infestations None View
Red blood cell count decreased None Investigations None View
Blood sodium decreased None Investigations None View
Haemoglobin decreased None Investigations None View
Liver function test abnormal None Investigations None View
Weight decreased None Investigations None View
Blood potassium increased None Investigations None View
Blood pressure decreased None Investigations None View
C-reactive protein increased None Investigations 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
Neck pain None Musculoskeletal and connective tissue disorders None View
Spinal osteoarthritis None Musculoskeletal and connective tissue disorders None View
Uterine leiomyoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Histiocytosis haematophagic None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Headache None Nervous system disorders None View
Somnolence None Nervous system disorders None View
Insomnia None Psychiatric disorders None View
Apathy None Psychiatric disorders None View
Pollakiuria None Renal and urinary disorders None View
Gynaecomastia None Reproductive system and breast disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Interstitial lung disease None Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal discomfort None Respiratory, thoracic and mediastinal disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Skin depigmentation None Skin and subcutaneous tissue disorders None View
Acne None Skin and subcutaneous tissue disorders None View
Skin exfoliation None Skin and subcutaneous tissue disorders None View
Urticaria None Skin and subcutaneous tissue disorders None View
Hypertension None Vascular disorders None View
Hypotension None Vascular disorders None View
Pericardial effusion None Cardiac disorders None View
Cardiac failure None Cardiac disorders None View
Eustachian tube obstruction None Ear and labyrinth disorders None View
Eyelid oedema None Eye disorders None View
Cataract None Eye disorders None View
Diarrhoea None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Dental caries None Gastrointestinal disorders None View
Gastritis None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Abdominal distension None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Enterocolitis None Gastrointestinal disorders None View
Gastric ulcer None Gastrointestinal disorders None View
Gastritis erosive None Gastrointestinal disorders None View
Gingival bleeding None Gastrointestinal disorders None View
Gingivitis None Gastrointestinal disorders None View
Pyrexia None General disorders None View
Oedema peripheral None General disorders None View
Malaise None General disorders None View
Chest pain None General disorders None View
Face oedema None General disorders None View
Oedema None General disorders None View
Fatigue None General disorders None View
Feeling abnormal None General disorders None View
Feeling hot None General disorders None View
Localised oedema None General disorders None View
Seasonal allergy None Immune system disorders None View
Nasopharyngitis None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Bronchitis None Infections and infestations None View
Rhinitis None Infections and infestations None View
Enteritis infectious None Infections and infestations None View
Contusion None Injury, poisoning and procedural complications None View
Tooth fracture None Injury, poisoning and procedural complications None View
Platelet count decreased None Investigations None View
Neutrophil count decreased None Investigations None View
White blood cell count decreased None Investigations None View
Alanine aminotransferase increased None Investigations None View
Lymphocyte count decreased None Investigations None View
Blood creatine phosphokinase increased None Investigations None View
Blood lactate dehydrogenase increased None Investigations None View
Blood phosphorus decreased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Blood albumin decreased None Investigations None View
Blood creatinine increased None Investigations None View
Blood alkaline phosphatase increased None Investigations None View
Blood potassium decreased None Investigations None View
Blood urea increased None Investigations None View
Blood uric acid increased None Investigations None View
Electrocardiogram QT corrected interval prolonged None Investigations None View
Gamma-glutamyltransferase increased None Investigations None View
Weight increased None Investigations None View
Protein urine present None Investigations None View
Blood calcium decreased None Investigations None View
Blood fibrinogen increased None Investigations None View
Blood folate decreased None Investigations None View
Haematocrit decreased None Investigations None View
Intraocular pressure increased None Investigations None View
Lymphocyte count increased None Investigations None View
Neutrophil count increased None Investigations None View
Protein total increased None Investigations None View
Vitamin B12 decreased None Investigations None View
Hypophosphataemia None Metabolism and nutrition disorders None View
Anorexia None Metabolism and nutrition disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Hyperuricaemia None Metabolism and nutrition disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Flank pain None Musculoskeletal and connective tissue disorders None View
Carpal tunnel syndrome None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Dizziness postural None Nervous system disorders None View
Dysgeusia None Nervous system disorders None View
Dermatitis contact None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View