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 @ 10:00 PM
Ignite Modification Date: 2025-12-25 @ 7:37 PM
NCT ID: NCT00531232
Description: Reported AEs and deaths were TEAEs that developed, worsened, or became serious during the treatment period (from signature of the informed consent form up to 45 days post last dose of study drug). Analysis was performed on FAS.
Frequency Threshold: 5
Time Frame: AE data were collected from signature of the informed consent form up to 45 days post last dose of study drug (maximum study duration: up to 4 years).
Study: NCT00531232
Study Brief: A Dose Confirmation Study of Oral Clofarabine for Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Clofarabine 25 mg/Day Participants received Clofarabine 25 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years). 14 None 19 24 24 24 View
Clofarabine 35 mg/Day Participants received Clofarabine 35 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years). 7 None 6 8 8 8 View
Clofarabine 55 mg/Day Participants received Clofarabine 55 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years). 4 None 4 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pseudomonal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Splenic Infarction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Clostridium Difficile Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Enterobacter Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Escherichia Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Herpes Simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Lobar Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Mycobacterium Avium Complex Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Oesophageal Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia Fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sinusitis Fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Staphylococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Streptococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Subdural Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood Lactate Dehydrogenase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Staphylococcus Test Positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Failure To Thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Tumour Lysis Syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Acute Myeloid Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Haemorrhage Intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Haemorrhagic Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Ureteric Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Pleuritic Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Disseminated Intravascular Coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Lymphadenopathy Mediastinal SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Retroperitoneal Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Aortic Valve Calcification SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Aortic Valve Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Arteriosclerosis Coronary Artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Dilatation Atrial SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Dilatation Ventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Left Ventricular Hypertrophy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Lipomatous Hypertrophy Of The Interatrial Septum SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Mitral Valve Incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Pulmonary Valve Incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Supraventricular Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Tricuspid Valve Incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Ventricular Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.1 View
Conjunctival Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Eye Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Retinal Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal Tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Faecal Incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gingival Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Ileus Paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Lip Dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Lip Haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Loose Tooth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Mouth Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Oral Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Reflux Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Tongue Discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Umbilical Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Feeling Jittery SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Generalised Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Gallbladder Disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hepatic Cyst SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Fungal Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Herpes Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Allergic Transfusion Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Bloody Airway Discharge SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Transfusion Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Cardiac Murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Ejection Fraction Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Electrocardiogram Qt Prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Electrocardiogram St-T Change SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Electrocardiogram St-T Segment Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Occult Blood Positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Qrs Axis Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Sputum Culture Positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Troponin I Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Urinary Casts SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Fluid Overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Tumour Lysis Syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Adrenal Adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Arachnoid Cyst SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cerebral Atrophy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cerebral Ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Hallucination, Visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Mental Status Changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Ketonuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal Cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Lung Infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Nasal Cyst SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Paranasal Sinus Hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Paranasal Sinus Mucosal Hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pharyngeal Erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pleural Fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pleuritic Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pulmonary Mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Blood Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Decubitus Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Drug Eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Ingrowing Nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Night Sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Palmar-Plantar Erythrodysaesthesia Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Swelling Face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Aortic Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Jugular Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Vascular Calcification SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View