Study: NCT01049776

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 32 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: yes
Organ System: Cardiac disorders
Notes: nonspecific T-wave abnormality
Frequency: 1 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: lymphopenia
Frequency: 1 affected / 32 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 32 at risk

Adverse event: Blood/Bone Marrow- AML
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 32 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 32 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 32 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 32 at risk

Adverse event: Cardiac Arrythmia- Systolic Anterior Motion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Troponin I
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 32 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 32 at risk

Adverse event: Left Ventricular Systolic Dysfunction (LVSD)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Prolonged QTc Interval
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 32 at risk

Adverse event: Supraventricular and Nodal Arrhthymia- Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 32 at risk

Adverse event: Supraventricular and Nodal Arrhthymia- Sinus Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 32 at risk

Adverse event: Supraventricular and Nodal Arrhthymia- Sinus Tachycardi
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 32 at risk

Adverse event: Ventricular Arrythmia- PVCs
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 32 at risk

Adverse event: PTT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 32 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 32 at risk

Adverse event: Rigors/Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 32 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 14 affected / 32 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 32 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hot Flashes/Flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 32 at risk

Adverse event: Thyroid Function, low
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 32 at risk

Adverse event: Thyroid Function, high
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 32 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 32 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 32 at risk

Adverse event: Dry Mouth/Salivary Gland
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 32 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 32 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Distention/Bloating- Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hemorrhage, GI- Lower GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hemorrhage, GU- Urinary NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hemorrhage, Pulmonary/Upper Respiratory- Nose
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hemorrhage, Pulmonary/Upper Respiratory- Respiratory Tract NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Liver Dysfunction/Failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 32 at risk

Adverse event: Infection- Blood
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Infection- Bronchitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 32 at risk

Adverse event: Infection- Lung (Pneumonia)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 32 at risk

Adverse event: Infection- Respiratory Tract NOS
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Infection- Sinus
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 32 at risk

Adverse event: Infection- Skin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Infection- Stomach
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Infection- Thrush
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 32 at risk

Adverse event: Infection- Wound
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Infection- Upper Respiratory
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Infection- Urinary Tract
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 32 at risk

Adverse event: Infection- Upper Airway NOS
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Infection- Oral Cavity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Albumin, serum- low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 32 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 32 at risk

Adverse event: ALT (SGPT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 32 at risk

Adverse event: AST (SGOT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 32 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 32 at risk

Adverse event: Calcium, serum- high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Calcium, serum- low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 32 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 32 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 32 at risk

Adverse event: Glucose, serum- high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 32 at risk

Adverse event: Glucose, serum- low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Lipase
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Magnesium, serum- high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Magnesium, serum- low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 32 at risk

Adverse event: Phosphate, serum- low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Potassium, serum- high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 32 at risk

Adverse event: Potassium, serum- low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 32 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 32 at risk

Adverse event: Sodium, serum- high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Sodium, serum- low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 32 at risk

Adverse event: Triglyceride, serum- high
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Bicarbonate, serum low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Muscle Weakness- generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 32 at risk

Adverse event: Muscle Weakness- upper extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Musculoskeletal/Soft Tissue- Leg Cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Musculoskeletal/Soft Tissue- Muscle Spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Musculoskeletal/Soft Tissue- Plantar Fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 32 at risk

Adverse event: Laryngeal nerve dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Mood Alteration- Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Neurology- Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Neuropathy: Motor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Neuropathy: Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 32 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Syncope (Fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Mood Alteration- Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Somnolence/Depressed Level of Consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Apnoea
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vision- Blurred Vision
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 32 at risk

Adverse event: Vision- Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vision- Flashing Lights/Floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Watery Eyes
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 32 at risk

Adverse event: Pain- Abdomen
Serious: no
Organ System: General disorders
Frequency: 13 affected / 32 at risk

Adverse event: Pain- Back
Serious: no
Organ System: General disorders
Frequency: 13 affected / 32 at risk

Adverse event: Pain- Bone
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Pain- Chest
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Pain- External Ear
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain- Extremity, Limb
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Pain- Finger
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain- Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 32 at risk

Adverse event: Pain- Joint
Serious: no
Organ System: General disorders
Frequency: 9 affected / 32 at risk

Adverse event: Pain- Muscle
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Pain- Neck
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pain- Throat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain- General NOS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Pain- Shoulder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Bronchospasm/Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 32 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Voice Changes/Dysathria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hiccoughs (Hiccups/Singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pneumonitis/Pulmonary Infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Incontinence, Urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Syndromes- Systemic Inflammatory Response System (SIRS)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk