Study: NCT01009515

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Induration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Hemoglobin levels decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Leukopenia (leukocytes decreased)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 19 at risk

Adverse event: Lymphopenia (lymphocytes decreased)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 19 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 19 at risk

Adverse event: Hypotension (Low blood pressure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Alopecia (Hair loss)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 19 at risk

Adverse event: Dermatology/Skin - Other: Folliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Skin hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pruritus (Itching)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 19 at risk

Adverse event: Increased sweating
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Anorexia (Decreased appetite)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Dyspepsia (Indigestion)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 19 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Urinary bladder haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Localised oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 19 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 19 at risk

Adverse event: Hyperbilirubinemia (high bilirubin levels)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hypercalcemia (high calcium levels)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hyperglycemia (high blood sugar)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 19 at risk

Adverse event: Hyperkalemia (high potassium levels)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hypermagnesemia (high magnesium levels)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hypoalbuminemia (low albumin protein levels)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Hypocalcemia (low calcium levels)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hypokalemia (low potassium levels)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Hypomagnesemia (low magnesium levels)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Hyponatremia (low sodium levels)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Hypophosphatemia (low phosphate levels)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Increased lactate dehydrogenase levels
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Laboratory test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Musculoskeletal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 19 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Ear, nose and throat examination abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Pharyngolaryngeal pain (throat pain)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Hypoxia (low blood oxygen)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Urinary frequency increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Urinary frequency decreased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 19 at risk