Study: NCT00411671

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 105 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 105 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 105 at risk

Adverse event: Ruptured Graft
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gastric ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Mental Status Changed
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 105 at risk

Adverse event: Acute Deterioration of General Health
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Troponin
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 105 at risk

Adverse event: Itchy Reddened Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Mild Swelling of the Finger Joints
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Bladder perforation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Pain, Breast Area
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Scrotal abscess
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypotonic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypovolemic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Non Functioning Right Kidney
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Perinephric abscess
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Generalized Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Decompensation Hydroelectrolytic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 105 at risk

Adverse event: Rectal tenesmus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Inflammed Caecum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 105 at risk

Adverse event: Bartholin Cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 105 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Gastrointestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 105 at risk

Adverse event: Hand Foot Syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Ejection fraction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 105 at risk

Adverse event: Fatal Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 105 at risk

Adverse event: Fatal Disseminated Intravasular Coagulation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Chloasma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Partial Thromboplastin Time Increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Bruising of Left Extremity
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Tetany
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 105 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 105 at risk

Adverse event: Myopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Toxic skin eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Vitiligo
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Malignant ascites
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Liver carcinoma ruptured
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hemianopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: ADH Secretion Abnormality
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 105 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cadiogenic Shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 105 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Interstitial Infiltrates
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Fatal Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Fatal Pustulosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Oversedation from Oxycontin
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pseudomonas Stutzeri Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 105 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Immune system disorders
Frequency: 6 affected / 105 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 105 at risk

Adverse event: Left Hemiparesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Rupture of Hepatocellular Carcinoma
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: General Health Degradation
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 105 at risk

Adverse event: Somnolence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 105 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 105 at risk

Adverse event: Fatal Cardiopulmonary Decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Streptococcus Positive
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Transient Troponin I elevated
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 105 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: GGTP Increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cheilitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Erosive Gastropathy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gastric Angiodysplasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Clostridium Difficile
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 105 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 105 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Aplastic Bone Marrow
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 105 at risk

Adverse event: Fatal Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Fatal Ischemic Heart Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Retinal vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 105 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 105 at risk

Adverse event: Rectal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Liver Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Thrombosis Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Limb discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pericarditis constrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 105 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Joint swelling
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 105 at risk

Adverse event: Fatal Subdural Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Fatal Brain Edema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hepatic infarction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Anal incontinence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Erythropoiesis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hepatic necrosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Liver Hemorrhage
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: C-reactive protein increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gouty arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Periapical Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Pneumatosis Intestinalis with Pneumoperitoneum
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cavitation of Pulmonary Hilar Mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Female genital tract fistula
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 105 at risk

Adverse event: Enterocutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 105 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: Necrosis of a Pleural Metastasis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Bronchopleural fistula
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Variceal Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cerebral Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Squamous Cell Cancer of Lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 105 at risk

Adverse event: Induration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 105 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 105 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 105 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 105 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 105 at risk

Adverse event: Elevated LDH
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Erythema Multiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 105 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 105 at risk

Adverse event: Fever Unknown Origin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Fever Without Neutropenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hand-Foot Syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 105 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 105 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 105 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Metabolic Laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Mood Alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 105 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pain (Chest Wall)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pain (Head/Headache)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Pain (NOS)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pain (Oral Cavity)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 105 at risk

Adverse event: Petechiae
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 105 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Syndromes (other)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 105 at risk