Study: NCT01740557

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 8 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 7 affected / 8 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 8 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 8 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 8 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 8 at risk

Adverse event: Monocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Absolute basophil cound decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Back Pain (right side lower back)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Bibasilar
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 8 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 8 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 8 at risk

Adverse event: Diminished lung sounds- right
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diminished lung sounds- left
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Diminished lung sound bilateral
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 8 at risk

Adverse event: Dermititis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Dark discoloration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 8 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Decreased protein
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Edema (face)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Edema (trunk)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: ECG QT
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Elevated LDH
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Gastric haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Gastitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Tinea Cruris (fungal goin infection)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Lung cracles- right
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 8 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Generalised edema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 8 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 8 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 8 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 8 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 8 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 8 at risk

Adverse event: Hypothyrodism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 8 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 8 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 8 at risk

Adverse event: Localised oedema
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Calcium ionised
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 8 at risk

Adverse event: Calcium ionised
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 8 at risk

Adverse event: Alkaline phosphate decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oliguria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Lung Infection (pneumonia)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 8 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Phosphorus increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 8 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Protein decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Palpations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Paresthesia (left shoulder)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Peripheral sensory neuropathy (bilateral hands/feet)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 8 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash masculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 8 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 8 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Superventricular tachycardis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sommolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Candida infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Total protein decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Blood uric acid decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 8 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 8 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk