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: 2025-12-25 @ 4:41 AM
Ignite Modification Date: 2025-12-26 @ 3:43 AM
NCT ID: NCT01030718
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01030718
Study Brief: Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Treated Participants Imatinib resistant or intolerant CML-CP disease cohort, Imatinib resistant or intolerant CML-AP/BP disease cohort, and Ph+ ALL subjects with resistance or intolerance to past therapy. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID. None None 33 54 54 54 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
Disseminated intravascular coagulation None Blood and lymphatic system disorders None View
Leukopenia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Atrial tachycardia None Cardiac disorders None View
Cardio-respiratory arrest None Cardiac disorders None View
Anal fistula None Gastrointestinal disorders None View
Enterocolitis None Gastrointestinal disorders None View
Gastrointestinal haemorrhage None Gastrointestinal disorders None View
Haematochezia None Gastrointestinal disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Ileus None Gastrointestinal disorders None View
Periodontitis None Gastrointestinal disorders None View
Pyrexia None General disorders None View
Malaise None General disorders None View
Therapeutic response decreased None General disorders None View
Disease progression None General disorders None View
Pneumonia None Infections and infestations None View
Enteritis infectious None Infections and infestations None View
Cellulitis None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Perianal abscess None Infections and infestations None View
Pseudomembranous colitis None Infections and infestations None View
Enterocolitis infectious None Infections and infestations None View
Subdural haematoma None Injury, poisoning and procedural complications None View
Brain herniation None Injury, poisoning and procedural complications None View
Drug toxicity None Injury, poisoning and procedural complications None View
Fracture None Injury, poisoning and procedural complications None View
Haemothorax None Injury, poisoning and procedural complications None View
Overdose None Injury, poisoning and procedural complications None View
Contusion None Injury, poisoning and procedural complications None View
Platelet count decreased None Investigations None View
Haemoglobin decreased None Investigations None View
Alanine aminotransferase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Haematocrit decreased None Investigations None View
Neutrophil count decreased None Investigations None View
Red blood cell count decreased None Investigations None View
White blood cell count decreased None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Intervertebral disc protrusion None Musculoskeletal and connective tissue disorders None View
Acute lymphocytic leukaemia recurrent None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tumour lysis syndrome None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Colon cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant pleural effusion None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Blast cell crisis None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung neoplasm malignant None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral haemorrhage None Nervous system disorders None View
Convulsion None Nervous system disorders None View
Subarachnoid haemorrhage None Nervous system disorders None View
Brain mass None Nervous system disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Interstitial lung disease None Respiratory, thoracic and mediastinal disorders None View
Pulmonary haemorrhage None Respiratory, thoracic and mediastinal disorders None View
Pulmonary oedema None Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders None View
Skin ulcer None Skin and subcutaneous tissue disorders None View
Haematoma None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia None Blood and lymphatic system disorders None View
Febrile neutropenia 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
Cardiomegaly None Cardiac disorders None View
Palpitations None Cardiac disorders None View
Pericardial effusion None Cardiac disorders None View
Sinus bradycardia None Cardiac disorders None View
Hypothyroidism None Endocrine disorders None View
Eyelid oedema None Eye disorders None View
Conjunctival haemorrhage None Eye disorders None View
Conjunctival hyperaemia None Eye disorders None View
Vision blurred None Eye disorders None View
Conjunctivitis None Eye disorders None View
Diarrhoea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Toothache None Gastrointestinal disorders None View
Abdominal distension None Gastrointestinal disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Cheilitis None Gastrointestinal disorders None View
Gingivitis None Gastrointestinal disorders None View
Haematochezia None Gastrointestinal disorders None View
Abdominal pain lower None Gastrointestinal disorders None View
Gingival bleeding None Gastrointestinal disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Stomach discomfort None Gastrointestinal disorders None View
Dental caries None Gastrointestinal disorders None View
Gastrointestinal haemorrhage None Gastrointestinal disorders None View
Gingival swelling None Gastrointestinal disorders None View
Pyrexia None General disorders None View
Malaise None General disorders None View
Oedema None General disorders None View
Oedema peripheral None General disorders None View
Face oedema None General disorders None View
Pain None General disorders None View
Chest pain None General disorders None View
Chills None General disorders None View
Chest discomfort None General disorders None View
Fatigue None General disorders None View
Hypothermia None General disorders None View
Seasonal allergy None Immune system disorders None View
Nasopharyngitis None Infections and infestations None View
Folliculitis None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Infection None Infections and infestations None View
Influenza None Infections and infestations None View
Excoriation None Injury, poisoning and procedural complications None View
Transfusion reaction None Injury, poisoning and procedural complications None View
Wound None Injury, poisoning and procedural complications None View
Neutrophil count decreased None Investigations None View
Platelet count decreased None Investigations None View
White blood cell count decreased None Investigations None View
Blood lactate dehydrogenase increased None Investigations None View
Lymphocyte count decreased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Alanine aminotransferase increased None Investigations None View
Blood creatine phosphokinase increased None Investigations None View
Gamma-glutamyltransferase increased None Investigations None View
Haematocrit decreased None Investigations None View
Haemoglobin decreased None Investigations None View
Red blood cell count decreased None Investigations None View
Blood phosphorus decreased None Investigations None View
Blood albumin decreased None Investigations None View
Protein urine present None Investigations None View
White blood cell count increased None Investigations None View
Protein total decreased None Investigations None View
Blood alkaline phosphatase increased None Investigations None View
Weight increased None Investigations None View
Blood urine present None Investigations None View
Weight decreased None Investigations None View
Blood uric acid increased None Investigations None View
CD4 lymphocytes decreased None Investigations None View
Blood creatinine increased None Investigations None View
Blood urea increased None Investigations None View
Urinary sediment abnormal None Investigations None View
Reticulocyte count decreased None Investigations None View
Urobilin urine present None Investigations None View
Blood potassium decreased None Investigations None View
Electrocardiogram QT corrected interval prolonged None Investigations None View
Glucose urine present None Investigations None View
Protein urine None Investigations None View
Blood bilirubin increased None Investigations None View
Blood magnesium increased None Investigations None View
Blood potassium increased None Investigations None View
C-reactive protein increased None Investigations None View
Liver function test abnormal None Investigations None View
Lymphocyte count increased None Investigations None View
Neutrophil count increased None Investigations None View
CD4 lymphocytes increased None Investigations None View
Blood pressure increased None Investigations None View
Blood sodium decreased None Investigations None View
Prothrombin time prolonged None Investigations None View
Reticulocyte count increased None Investigations None View
Platelet count increased None Investigations None View
Activated partial thromboplastin time prolonged None Investigations None View
Blood chloride decreased None Investigations None View
Eosinophil count increased None Investigations None View
Urine ketone body present None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Decreased appetite None Metabolism and nutrition disorders None View
Hypophosphataemia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Musculoskeletal stiffness None Musculoskeletal and connective tissue disorders None View
Skin papilloma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Headache None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Hypoaesthesia None Nervous system disorders None View
Dysgeusia None Nervous system disorders None View
Insomnia None Psychiatric disorders None View
Haematuria 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
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
Rhinorrhoea None Respiratory, thoracic and mediastinal disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Erythema None Skin and subcutaneous tissue disorders None View
Haemorrhage subcutaneous None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Purpura None Skin and subcutaneous tissue disorders None View
Acne None Skin and subcutaneous tissue disorders None View
Petechiae None Skin and subcutaneous tissue disorders None View
Eczema None Skin and subcutaneous tissue disorders None View
Skin exfoliation None Skin and subcutaneous tissue disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Rash papular None Skin and subcutaneous tissue disorders None View
Hypertension None Vascular disorders None View
Hypotension None Vascular disorders None View
Joint swelling None Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders None View