Study: NCT01769209

Adverse event: Neutropenic fever (febrile neutropenia)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Disseminated intravascular coagulation (DIC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Colon and caecum inflammation (typhilitis, colitis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hepatobilliary Disorders-Other, veno-occlusive disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Septic shock (sepsis)
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 18 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Neutropenic fever (febrile neutropenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 18 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 18 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 18 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 18 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 18 at risk

Adverse event: Heart palpitations (tachycardia)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 18 at risk

Adverse event: Heart failure (congestive heart failure)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 18 at risk

Adverse event: Decreased hearing (hearing impaired)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 18 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting (nausea)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 18 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 18 at risk

Adverse event: Gastroesophageal reflux disease (GERD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 18 at risk

Adverse event: Colon and caecum inflammation (typhilitis, colitis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 18 at risk

Adverse event: Perianal pain ( Anal pain)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Swelling (edema)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 18 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Hepatobilliary Disorders-Other, liver abscess
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Infections and infestations-Other,thrush
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 18 at risk

Adverse event: Respiratory infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 18 at risk

Adverse event: Infections and infestations-Other, Herpes simplex virus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 18 at risk

Adverse event: Septic shock (sepsis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory syncytial virus (RSV)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 18 at risk

Adverse event: Infections and infestations-Other, Herpes simplex virus Line, sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 18 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 18 at risk

Adverse event: Partial thromboplastin time (PTT) high
Serious: no
Organ System: Investigations
Frequency: 7 affected / 18 at risk

Adverse event: Aspartate aminotransferase (AST) elevated
Serious: no
Organ System: Investigations
Frequency: 14 affected / 18 at risk

Adverse event: Alanine aminotransferase (ALT) elevated
Serious: no
Organ System: Investigations
Frequency: 15 affected / 18 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 18 at risk

Adverse event: Alkaline Phosphatase elevated
Serious: no
Organ System: Investigations
Frequency: 9 affected / 18 at risk

Adverse event: Gamma-glutamyl transferase (GGT) elevated
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 18 at risk

Adverse event: Lipase high
Serious: no
Organ System: Investigations
Frequency: 6 affected / 18 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 18 at risk

Adverse event: Apetite loss (anorexia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 18 at risk

Adverse event: Hypoalbuminemia (Albumin low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 18 at risk

Adverse event: Hypertriglyceridemia (Triglycerides high)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Hypernatremia -Sodium high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Hyponatremia -Sodium low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 18 at risk

Adverse event: Hypokalemia -Potassium low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 18 at risk

Adverse event: Hyperkalemia -Potassium high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hypomagnesemia -Magnesium low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 18 at risk

Adverse event: Hypocalcemia -Calcium low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 18 at risk

Adverse event: Hypophosphatemia -Phosphorus low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 18 at risk

Adverse event: Metabolism and Nutrition Disorders-Other Phosphorus high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hyperglycemia (Glucose high)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 18 at risk

Adverse event: Hypoglycemia -Glucose low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 18 at risk

Adverse event: Leg weakness (generalized muscle weakness )
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, musculoskeletal Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 18 at risk

Adverse event: Avascular necrosis (Bone infarct)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 18 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Restless leg (akathisia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 18 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 18 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 18 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 18 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain during urination (dysuria)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Scrotal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Breath shortness (Dyspnea)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Chest pain (pleuritic pain)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nosebleed (Epistaxis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Skin ulceration -Lip lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: High blood pressure (hypertension)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 18 at risk

Adverse event: Low blood pressure (hyportension)
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 18 at risk