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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:17 AM
NCT ID: NCT00716820
Description: The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 1.0
Time Frame: None
Study: NCT00716820
Study Brief: Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sunitinib Malate Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert. None None 259 472 429 472 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Device related sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Cholangitis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pyelonephritis acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Neutropenic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gingival abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Intervertebral discitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Peritonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gastric cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Tumour necrosis NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Gastrointestinal stromal tumour NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Thrombotic microangiopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Haemorrhagic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View
Hypopituitarism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Cachexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyperamylasaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypercreatininaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Tumour lysis syndrome NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Loss of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Altered state of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Ruptured cerebral aneurysm NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Cardiac failure acute NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardio-respiratory arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Aneurysm ruptured NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Interstitial lung disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Laryngeal oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary haemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Gastroduodenal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastric perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrointestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gingival bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Enterocolonic fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Small intestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrointestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Large intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pancreatic enzyme abnormality NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Jaundice cholestatic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Acute generalised exanthematous pustulosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dermatitis bullous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Nephrotic syndrome NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Chronic kidney disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Vesical fistula NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Haematocrit decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood uric acid increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Glomerular filtration rate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Clavicle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Neoplasm progression NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Hyperammonaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Hepatic failure NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Cholangitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Renal disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Multi-organ failure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Red blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Bone marrow failure NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Hepatic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Liver disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Rhabdomyolysis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Posterior reversible encephalopathy syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Intra-abdominal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hyperuricaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Disseminated intravascular coagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Tumour haemorrhage NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Bone marrow failure NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Left ventricular dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Eyelid oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Cheilitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Glossitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Proctalgia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Anal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pancreatic enzyme abnormality NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Performance status decreased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Liver disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Periodontitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Haematocrit decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Ejection fraction decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood thyroid stimulating hormone increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood uric acid increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Red blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hyperamylasaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyperlipasaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyperuricaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Yellow skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Pigmentation disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Haemorrhage subcutaneous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Skin discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View