Study: NCT01659567

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Anemia fourth degree
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 516 at risk

Adverse event: Thrombocytopenia fourth degree
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Neutropenia fourth degree
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 516 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 516 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Lingual bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 516 at risk

Adverse event: Agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 516 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 516 at risk

Adverse event: Thyrotoxicosis second degree
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 516 at risk

Adverse event: Thrombocytopenia second degree
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Thrombocytopenia third degree
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 516 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 516 at risk

Adverse event: Leukopenia second degree
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 516 at risk

Adverse event: Leukopenia third degree
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 516 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 516 at risk

Adverse event: Neutropenia second degree
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 516 at risk

Adverse event: Neutropenia third degree
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 516 at risk

Adverse event: Liver enzymes incresed (ALT, AST other)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 516 at risk

Adverse event: ST elevation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 516 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Paresthesia (numbness in hands)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Hemorrhoid varicose veins
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Hyperaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Flushing
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Alopecia/hair loss
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 516 at risk

Adverse event: Itching/pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 516 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 516 at risk

Adverse event: Anal pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 516 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 516 at risk

Adverse event: Herpes rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 516 at risk

Adverse event: Left nostril furuncle
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 516 at risk

Adverse event: Sweating - general
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 516 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 516 at risk

Adverse event: Toxidermia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 516 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 516 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 516 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 516 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 516 at risk

Adverse event: Muscle weakness in legs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 516 at risk

Adverse event: Allergic reactions
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 516 at risk

Adverse event: Autoimmune thyroiditis
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 516 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 516 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 516 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Sexual potency impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 516 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Flue-like syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 516 at risk

Adverse event: Sour throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 516 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Abdominal pain upper/epigastric pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 516 at risk

Adverse event: Meteorism (flatulence)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 516 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 128 affected / 516 at risk

Adverse event: Adynamy
Serious: no
Organ System: General disorders
Frequency: 10 affected / 516 at risk

Adverse event: General weakness
Serious: no
Organ System: General disorders
Frequency: 75 affected / 516 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 516 at risk

Adverse event: Sweating - general
Serious: no
Organ System: General disorders
Frequency: 1 affected / 516 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 516 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 516 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 516 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 516 at risk

Adverse event: Scalding during urination/urine scald
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 516 at risk

Adverse event: Sexual potency impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 516 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 516 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 516 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 516 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 516 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 516 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 516 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 516 at risk

Adverse event: Emotional liability
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 516 at risk